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Use of the Avulux® Lenses as an Aid in Reducing the Impact of Migraine Headaches

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04341298
Recruitment Status : Completed
First Posted : April 10, 2020
Results First Posted : January 9, 2023
Last Update Posted : January 9, 2023
Sponsor:
Collaborator:
Imarc Research, Inc.
Information provided by (Responsible Party):
Avulux, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Migraine
Interventions Other: 11-point pain scale
Other: Headache diary
Device: Avulux®
Device: Sham Avulux®
Enrollment 78
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Avulux® Device Control/Sham Device
Hide Arm/Group Description

Subjects will be instructed to use the glasses for four weeks. They will be instructed to put the glasses on at the first signs or symptoms consistent with the onset of a migraine attack or at the first onset of aura and keep the glasses on until their headache has resolved.

11-point pain scale: Subjects will be asked to rate their headache pain using an 11-point scale, i.e. on an integer scale from 0 to 10 inclusive, with 0 indicating no pain and 10 indicating the worst pain imaginable.

Headache diary: Subjects will be asked to record specific information for the first (and all subsequent) severe or very severe migraine headaches that they experience while enrolled in the study.

Avulux®: Avulux® device

Subjects will be instructed to use the glasses for four weeks. They will be instructed to put the glasses on at the first signs or symptoms consistent with the onset of a migraine attack or at the first onset of aura and keep the glasses on until their headache has resolved.

11-point pain scale: Subjects will be asked to rate their headache pain using an 11-point scale, i.e. on an integer scale from 0 to 10 inclusive, with 0 indicating no pain and 10 indicating the worst pain imaginable.

Headache diary: Subjects will be asked to record specific information for the first (and all subsequent) severe or very severe migraine headaches that they experience while enrolled in the study.

Sham Avulux®: Sham Avulux®

Period Title: Overall Study
Started 38 40
Completed 38 40
Not Completed 0 0
Arm/Group Title Avulux® Device Control/Sham Device Total
Hide Arm/Group Description

Subjects will be instructed to use the glasses for four weeks. They will be instructed to put the glasses on at the first signs or symptoms consistent with the onset of a migraine attack or at the first onset of aura and keep the glasses on until their headache has resolved.

11-point pain scale: Subjects will be asked to rate their headache pain using an 11-point scale, i.e. on an integer scale from 0 to 10 inclusive, with 0 indicating no pain and 10 indicating the worst pain imaginable.

Headache diary: Subjects will be asked to record specific information for the first (and all subsequent) severe or very severe migraine headaches that they experience while enrolled in the study.

Avulux®: Avulux® device

Subjects will be instructed to use the glasses for four weeks. They will be instructed to put the glasses on at the first signs or symptoms consistent with the onset of a migraine attack or at the first onset of aura and keep the glasses on until their headache has resolved.

11-point pain scale: Subjects will be asked to rate their headache pain using an 11-point scale, i.e. on an integer scale from 0 to 10 inclusive, with 0 indicating no pain and 10 indicating the worst pain imaginable.

Headache diary: Subjects will be asked to record specific information for the first (and all subsequent) severe or very severe migraine headaches that they experience while enrolled in the study.

Sham Avulux®: Sham Avulux®

Total of all reporting groups
Overall Number of Baseline Participants 38 40 78
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 38 participants 40 participants 78 participants
48.1  (13.3) 44.3  (13.9) 46.2  (13.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 40 participants 78 participants
Female
31
  81.6%
33
  82.5%
64
  82.1%
Male
7
  18.4%
7
  17.5%
14
  17.9%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 40 participants 78 participants
White
31
  81.6%
34
  85.0%
65
  83.3%
Black or African-American
4
  10.5%
3
   7.5%
7
   9.0%
Hispanic or Latino
1
   2.6%
0
   0.0%
1
   1.3%
Asian
0
   0.0%
1
   2.5%
1
   1.3%
Other
2
   5.3%
2
   5.0%
4
   5.1%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 38 participants 40 participants 78 participants
38
 100.0%
40
 100.0%
78
 100.0%
1.Primary Outcome
Title Change in 11-point Pain Scale Score After Two Hours (First Severe Headache)
Hide Description Change in migraine pain from baseline to 2 hours after device application, based on first severe or very severe migraine headache experienced by a study subject (i.e. baseline pain score of 6 or higher). Pain scale is an 11-point scale, with integer values from 0 (no pain) to 10 (worst pain imaginable) inclusive.
Time Frame from baseline to 2 hours after device application
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population consists of the participants who experienced a minimum of one severe headache during the study and for whom pain scores were reported at baseline and 2 hours after device application for their first severe headache.
Arm/Group Title Avulux® Device Control/Sham Device
Hide Arm/Group Description:

Subjects will be instructed to use the glasses for four weeks. They will be instructed to put the glasses on at the first signs or symptoms consistent with the onset of a migraine attack or at the first onset of aura and keep the glasses on until their headache has resolved.

11-point pain scale: Subjects will be asked to rate their headache pain using an 11-point scale, i.e. on an integer scale from 0 to 10 inclusive, with 0 indicating no pain and 10 indicating the worst pain imaginable.

Headache diary: Subjects will be asked to record specific information for the first (and all subsequent) severe or very severe migraine headaches that they experience while enrolled in the study.

Avulux®: Avulux® device

Subjects will be instructed to use the glasses for four weeks. They will be instructed to put the glasses on at the first signs or symptoms consistent with the onset of a migraine attack or at the first onset of aura and keep the glasses on until their headache has resolved.

11-point pain scale: Subjects will be asked to rate their headache pain using an 11-point scale, i.e. on an integer scale from 0 to 10 inclusive, with 0 indicating no pain and 10 indicating the worst pain imaginable.

Headache diary: Subjects will be asked to record specific information for the first (and all subsequent) severe or very severe migraine headaches that they experience while enrolled in the study.

Sham Avulux®: Sham Avulux®

Overall Number of Participants Analyzed 26 29
Mean (Standard Deviation)
Unit of Measure: score on a scale
-1.42  (1.90) -1.14  (1.43)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Avulux® Device, Control/Sham Device
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.65
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Change in 11-point Pain Scale Score After Four Hours (First Severe Headache)
Hide Description Change in migraine pain from baseline to 4 hours after device application, based on first severe or very severe migraine headache experienced by a study subject (i.e. baseline pain score of 6 or higher). Pain scale is an 11-point scale, with integer values from 0 (no pain) to 10 (worst pain imaginable) inclusive.
Time Frame from baseline to four hours after device application
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population consists of the participants who experienced a minimum of one severe headache during the study and for whom pain scores were reported at baseline and 4 hours after device application for their first severe headache.
Arm/Group Title Avulux® Device Control/Sham Device
Hide Arm/Group Description:

Subjects will be instructed to use the glasses for four weeks. They will be instructed to put the glasses on at the first signs or symptoms consistent with the onset of a migraine attack or at the first onset of aura and keep the glasses on until their headache has resolved.

11-point pain scale: Subjects will be asked to rate their headache pain using an 11-point scale, i.e. on an integer scale from 0 to 10 inclusive, with 0 indicating no pain and 10 indicating the worst pain imaginable.

Headache diary: Subjects will be asked to record specific information for the first (and all subsequent) severe or very severe migraine headaches that they experience while enrolled in the study.

Avulux®: Avulux® device

Subjects will be instructed to use the glasses for four weeks. They will be instructed to put the glasses on at the first signs or symptoms consistent with the onset of a migraine attack or at the first onset of aura and keep the glasses on until their headache has resolved.

11-point pain scale: Subjects will be asked to rate their headache pain using an 11-point scale, i.e. on an integer scale from 0 to 10 inclusive, with 0 indicating no pain and 10 indicating the worst pain imaginable.

Headache diary: Subjects will be asked to record specific information for the first (and all subsequent) severe or very severe migraine headaches that they experience while enrolled in the study.

Sham Avulux®: Sham Avulux®

Overall Number of Participants Analyzed 21 25
Mean (Standard Deviation)
Unit of Measure: score on a scale
-2.67  (2.67) -2.80  (2.66)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Avulux® Device, Control/Sham Device
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.87
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Other Pre-specified Outcome
Title Number of Subjects With Quantifiable Improvement in Pain Score After Two Hours (First Severe Headache)
Hide Description Number of subjects who show quantifiable improvement in overall migraine impact, as measured by a change in migraine pain from severe (i.e. baseline pain score of 6 or higher) to mild/no pain (defined as a pain score of 3 or less) after an elapsed time of 2 hours following application of the device, based on first severe or very severe migraine headache experienced by a study subject. Pain scale is an 11-point scale, with integer values from 0 (no pain) to 10 (worst pain imaginable) inclusive.
Time Frame from baseline to 2 hours after device application
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population consists of the participants who experienced a minimum of one severe headache during the study and for whom pain scores were reported at baseline and 2 hours after device application for their first severe headache.
Arm/Group Title Avulux® Device Control/Sham Device
Hide Arm/Group Description:

Subjects will be instructed to use the glasses for four weeks. They will be instructed to put the glasses on at the first signs or symptoms consistent with the onset of a migraine attack or at the first onset of aura and keep the glasses on until their headache has resolved.

11-point pain scale: Subjects will be asked to rate their headache pain using an 11-point scale, i.e. on an integer scale from 0 to 10 inclusive, with 0 indicating no pain and 10 indicating the worst pain imaginable.

Headache diary: Subjects will be asked to record specific information for the first (and all subsequent) severe or very severe migraine headaches that they experience while enrolled in the study.

Avulux®: Avulux® device

Subjects will be instructed to use the glasses for four weeks. They will be instructed to put the glasses on at the first signs or symptoms consistent with the onset of a migraine attack or at the first onset of aura and keep the glasses on until their headache has resolved.

11-point pain scale: Subjects will be asked to rate their headache pain using an 11-point scale, i.e. on an integer scale from 0 to 10 inclusive, with 0 indicating no pain and 10 indicating the worst pain imaginable.

Headache diary: Subjects will be asked to record specific information for the first (and all subsequent) severe or very severe migraine headaches that they experience while enrolled in the study.

Sham Avulux®: Sham Avulux®

Overall Number of Participants Analyzed 26 29
Measure Type: Count of Participants
Unit of Measure: Participants
2
   7.7%
4
  13.8%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Avulux® Device, Control/Sham Device
Comments Each subject was stratified by baseline pain score for the first severe headache that they experienced (score of 6-7 vs. 8-10). The total number of subjects, and the number of subjects with a pain score of 3 or less after 2 hours, were tabulated within each stratum. A Cochran-Mantel-Haenszel test was conducted to test the hypothesis of lack of association between the proportion of subjects reporting mild or no symptoms after 2 hours and the type of device, across all strata.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.66
Comments [Not Specified]
Method Mantel Haenszel
Comments Subjects were stratified based on baseline pain score (6-7 vs. 8-10) prior to analysis using Cochran-Mantel-Haenszel test
4.Other Pre-specified Outcome
Title Number of Subjects Who Require the Use of Abortive Medications (First Severe Headache)
Hide Description Number of subjects who require abortive headache medication (e.g. analgesic or triptan) to control their first severe or very severe migraine headache (i.e. baseline pain score of 6 or higher) within 8 hours following application of the device. Pain scale is an 11-point scale, with integer values from 0 (no pain) to 10 (worst pain imaginable) inclusive.
Time Frame baseline to 8 hours after device application
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population consists of the participants who experienced a minimum of one severe headache during the study and who recorded whether abortive medications were used within 8 hours of device application for their first severe headache.
Arm/Group Title Avulux® Device Control/Sham Device
Hide Arm/Group Description:

Subjects will be instructed to use the glasses for four weeks. They will be instructed to put the glasses on at the first signs or symptoms consistent with the onset of a migraine attack or at the first onset of aura and keep the glasses on until their headache has resolved.

11-point pain scale: Subjects will be asked to rate their headache pain using an 11-point scale, i.e. on an integer scale from 0 to 10 inclusive, with 0 indicating no pain and 10 indicating the worst pain imaginable.

Headache diary: Subjects will be asked to record specific information for the first (and all subsequent) severe or very severe migraine headaches that they experience while enrolled in the study.

Avulux®: Avulux® device

Subjects will be instructed to use the glasses for four weeks. They will be instructed to put the glasses on at the first signs or symptoms consistent with the onset of a migraine attack or at the first onset of aura and keep the glasses on until their headache has resolved.

11-point pain scale: Subjects will be asked to rate their headache pain using an 11-point scale, i.e. on an integer scale from 0 to 10 inclusive, with 0 indicating no pain and 10 indicating the worst pain imaginable.

Headache diary: Subjects will be asked to record specific information for the first (and all subsequent) severe or very severe migraine headaches that they experience while enrolled in the study.

Sham Avulux®: Sham Avulux®

Overall Number of Participants Analyzed 26 30
Measure Type: Count of Participants
Unit of Measure: Participants
11
  42.3%
11
  36.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Avulux® Device, Control/Sham Device
Comments Each subject was stratified by baseline pain score for the first severe headache that they experienced (score of 6-7 vs. 8-10). The total number of subjects, and the number of subjects requiring abortive medication within 8 hours were tabulated within each stratum. A Cochran-Mantel-Haenszel test was conducted to test the hypothesis of lack of association between the proportion of subjects requiring abortive medication within 8 hours and the type of device, across all strata.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.59
Comments [Not Specified]
Method Mantel Haenszel
Comments Subjects were stratified based on baseline pain score (6-7 vs. 8-10) prior to analysis using Cochran-Mantel-Haenszel test
5.Other Pre-specified Outcome
Title Number of Subjects Suffering From Light Sensitivity After 2 Hours (First Severe Headache)
Hide Description Number of subjects suffering from light sensitivity after elapsed time of 2 hours following application of the device, based on first severe or very severe migraine headache experienced by a study subject (i.e. baseline pain score of 6 or higher). Pain scale is an 11-point scale, with integer values from 0 (no pain) to 10 (worst pain imaginable) inclusive.
Time Frame 2 hours after device application
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population consists of the participants who experienced a minimum of one severe headache during the study and who recorded whether light sensitivity was experienced two hours after device application for their first severe headache.
Arm/Group Title Avulux® Device Control/Sham Device
Hide Arm/Group Description:

Subjects will be instructed to use the glasses for four weeks. They will be instructed to put the glasses on at the first signs or symptoms consistent with the onset of a migraine attack or at the first onset of aura and keep the glasses on until their headache has resolved.

11-point pain scale: Subjects will be asked to rate their headache pain using an 11-point scale, i.e. on an integer scale from 0 to 10 inclusive, with 0 indicating no pain and 10 indicating the worst pain imaginable.

Headache diary: Subjects will be asked to record specific information for the first (and all subsequent) severe or very severe migraine headaches that they experience while enrolled in the study.

Avulux®: Avulux® device

Subjects will be instructed to use the glasses for four weeks. They will be instructed to put the glasses on at the first signs or symptoms consistent with the onset of a migraine attack or at the first onset of aura and keep the glasses on until their headache has resolved.

11-point pain scale: Subjects will be asked to rate their headache pain using an 11-point scale, i.e. on an integer scale from 0 to 10 inclusive, with 0 indicating no pain and 10 indicating the worst pain imaginable.

Headache diary: Subjects will be asked to record specific information for the first (and all subsequent) severe or very severe migraine headaches that they experience while enrolled in the study.

Sham Avulux®: Sham Avulux®

Overall Number of Participants Analyzed 25 29
Measure Type: Count of Participants
Unit of Measure: Participants
9
  36.0%
16
  55.2%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Avulux® Device, Control/Sham Device
Comments Each subject was stratified by baseline pain score for the first severe headache that they experienced (score of 6-7 vs. 8-10). The total number of subjects, and the number of subjects experiencing light sensitivity after 2 hours, were tabulated within each stratum. A Cochran-Mantel-Haenszel test was conducted to test the hypothesis of lack of association between the proportion of subjects reporting light sensitivity after 2 hours and the type of device, across all strata.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.19
Comments [Not Specified]
Method Mantel Haenszel
Comments Subjects were stratified based on baseline pain score (6-7 vs. 8-10) prior to analysis using Cochran-Mantel-Haenszel test
6.Other Pre-specified Outcome
Title Number of Subjects Suffering From Light Sensitivity After 4 Hours (First Severe Headache)
Hide Description Number of subjects suffering from light sensitivity after elapsed time of 4 hours following application of the device, based on first severe or very severe migraine headache experienced by a study subject (i.e. baseline pain score of 6 or higher). Pain scale is an 11-point scale, with integer values from 0 (no pain) to 10 (worst pain imaginable) inclusive.
Time Frame 4 hours after device application
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population consists of the participants who experienced a minimum of one severe headache during the study and who recorded whether light sensitivity was experienced four hours after device application for their first severe headache.
Arm/Group Title Avulux® Device Control/Sham Device
Hide Arm/Group Description:

Subjects will be instructed to use the glasses for four weeks. They will be instructed to put the glasses on at the first signs or symptoms consistent with the onset of a migraine attack or at the first onset of aura and keep the glasses on until their headache has resolved.

11-point pain scale: Subjects will be asked to rate their headache pain using an 11-point scale, i.e. on an integer scale from 0 to 10 inclusive, with 0 indicating no pain and 10 indicating the worst pain imaginable.

Headache diary: Subjects will be asked to record specific information for the first (and all subsequent) severe or very severe migraine headaches that they experience while enrolled in the study.

Avulux®: Avulux® device

Subjects will be instructed to use the glasses for four weeks. They will be instructed to put the glasses on at the first signs or symptoms consistent with the onset of a migraine attack or at the first onset of aura and keep the glasses on until their headache has resolved.

11-point pain scale: Subjects will be asked to rate their headache pain using an 11-point scale, i.e. on an integer scale from 0 to 10 inclusive, with 0 indicating no pain and 10 indicating the worst pain imaginable.

Headache diary: Subjects will be asked to record specific information for the first (and all subsequent) severe or very severe migraine headaches that they experience while enrolled in the study.

Sham Avulux®: Sham Avulux®

Overall Number of Participants Analyzed 20 25
Measure Type: Count of Participants
Unit of Measure: Participants
7
  35.0%
10
  40.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Avulux® Device, Control/Sham Device
Comments Each subject was stratified by baseline pain score for the first severe headache that they experienced (score of 6-7 vs. 8-10). The total number of subjects, and the number of subjects experiencing light sensitivity after 4 hours, were tabulated within each stratum. A Cochran-Mantel-Haenszel test was conducted to test the hypothesis of lack of association between the proportion of subjects reporting light sensitivity after 4 hours and the type of device, across all strata.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments [Not Specified]
Method Mantel Haenszel
Comments Subjects were stratified based on baseline pain score (6-7 vs. 8-10) prior to analysis using Cochran-Mantel-Haenszel test
7.Post-Hoc Outcome
Title Change in 11-point Pain Scale Score After Two Hours (All Headaches)
Hide Description Change in migraine pain from baseline to 2 hours after device application, based on all migraine headaches experienced by a study subjects (i.e. baseline pain score of 2 or greater). Pain scale is an 11-point scale, with integer values from 0 (no pain) to 10 (worst pain imaginable) inclusive.
Time Frame from baseline to 2 hours after device application
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Avulux® Device Control/Sham Device
Hide Arm/Group Description:

Subjects will be instructed to use the glasses for four weeks. They will be instructed to put the glasses on at the first signs or symptoms consistent with the onset of a migraine attack or at the first onset of aura and keep the glasses on until their headache has resolved.

11-point pain scale: Subjects will be asked to rate their headache pain using an 11-point scale, i.e. on an integer scale from 0 to 10 inclusive, with 0 indicating no pain and 10 indicating the worst pain imaginable.

Headache diary: Subjects will be asked to record specific information for all migraine headaches (baseline pain score of 2 or greater) that they experience while enrolled in the study.

Avulux®: Avulux® device

Subjects will be instructed to use the glasses for four weeks. They will be instructed to put the glasses on at the first signs or symptoms consistent with the onset of a migraine attack or at the first onset of aura and keep the glasses on until their headache has resolved.

11-point pain scale: Subjects will be asked to rate their headache pain using an 11-point scale, i.e. on an integer scale from 0 to 10 inclusive, with 0 indicating no pain and 10 indicating the worst pain imaginable.

Headache diary: Subjects will be asked to record specific information for all migraine headaches (baseline pain score of 2 or greater) that they experience while enrolled in the study.

Sham Avulux®: Sham Avulux®

Overall Number of Participants Analyzed 38 40
Mean (Standard Deviation)
Unit of Measure: score on a scale
-1.91  (2.13) -1.05  (1.82)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Avulux® Device, Control/Sham Device
Comments Null hypothesis is that 2 hour difference in pain score is equivalent between study arms, after adjusting for baseline pain score and headache medication use.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.021
Comments [Not Specified]
Method Mixed Models Analysis
Comments Pain score difference after 2 hours modeled as a function of study arm, baseline pain score and headache medication use.
8.Post-Hoc Outcome
Title Change in 11-point Pain Scale Score After Four Hours (All Headaches)
Hide Description Change in migraine pain from baseline to 4 hours after device application, based on all migraine headaches experienced by a study subjects (i.e. baseline pain score of 2 or greater). Pain scale is an 11-point scale, with integer values from 0 (no pain) to 10 (worst pain imaginable) inclusive.
Time Frame from baseline to 4 hours after device application
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Avulux® Device Control/Sham Device
Hide Arm/Group Description:

Subjects will be instructed to use the glasses for four weeks. They will be instructed to put the glasses on at the first signs or symptoms consistent with the onset of a migraine attack or at the first onset of aura and keep the glasses on until their headache has resolved.

11-point pain scale: Subjects will be asked to rate their headache pain using an 11-point scale, i.e. on an integer scale from 0 to 10 inclusive, with 0 indicating no pain and 10 indicating the worst pain imaginable.

Headache diary: Subjects will be asked to record specific information for all migraine headaches (baseline pain score of 2 or greater) that they experience while enrolled in the study.

Avulux®: Avulux® device

Subjects will be instructed to use the glasses for four weeks. They will be instructed to put the glasses on at the first signs or symptoms consistent with the onset of a migraine attack or at the first onset of aura and keep the glasses on until their headache has resolved.

11-point pain scale: Subjects will be asked to rate their headache pain using an 11-point scale, i.e. on an integer scale from 0 to 10 inclusive, with 0 indicating no pain and 10 indicating the worst pain imaginable.

Headache diary: Subjects will be asked to record specific information for all migraine headaches (baseline pain score of 2 or greater) that they experience while enrolled in the study.

Sham Avulux®: Sham Avulux®

Overall Number of Participants Analyzed 38 40
Mean (Standard Deviation)
Unit of Measure: score on a scale
-3.46  (2.87) -2.10  (2.80)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Avulux® Device, Control/Sham Device
Comments Null hypothesis is that 4 hour difference in pain score is equivalent between study arms, after adjusting for baseline pain score and headache medication use.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.019
Comments [Not Specified]
Method Mixed Models Analysis
Comments Pain score difference after 4 hours modeled as a function of study arm, baseline pain score and headache medication use.
9.Post-Hoc Outcome
Title Number of Headaches With Associated Light Sensitivity After 2 Hours (All Headaches)
Hide Description Number of headaches with associated light sensitivity after elapsed time of 2 hours following application of the device, based on all migraine headaches experienced by study subjects (i.e. baseline pain score of 2 or higher). Pain scale is an 11-point scale, with integer values from 0 (no pain) to 10 (worst pain imaginable) inclusive.
Time Frame from baseline to 2 hours after device application
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Avulux® Device Control/Sham Device
Hide Arm/Group Description:

Subjects will be instructed to use the glasses for four weeks. They will be instructed to put the glasses on at the first signs or symptoms consistent with the onset of a migraine attack or at the first onset of aura and keep the glasses on until their headache has resolved.

11-point pain scale: Subjects will be asked to rate their headache pain using an 11-point scale, i.e. on an integer scale from 0 to 10 inclusive, with 0 indicating no pain and 10 indicating the worst pain imaginable.

Headache diary: Subjects will be asked to record specific information for all migraine headaches (baseline pain score of 2 or greater) that they experience while enrolled in the study.

Avulux®: Avulux® device

Subjects will be instructed to use the glasses for four weeks. They will be instructed to put the glasses on at the first signs or symptoms consistent with the onset of a migraine attack or at the first onset of aura and keep the glasses on until their headache has resolved.

11-point pain scale: Subjects will be asked to rate their headache pain using an 11-point scale, i.e. on an integer scale from 0 to 10 inclusive, with 0 indicating no pain and 10 indicating the worst pain imaginable.

Headache diary: Subjects will be asked to record specific information for all migraine headaches (baseline pain score of 2 or greater) that they experience while enrolled in the study.

Sham Avulux®: Sham Avulux®

Overall Number of Participants Analyzed 38 40
Overall Number of Units Analyzed
Type of Units Analyzed: Headaches
97 102
Measure Type: Number
Unit of Measure: headaches
31 63
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Avulux® Device, Control/Sham Device
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Null hypothesis is that proportion of headaches with light sensitivity experienced after 2 hours is equivalent between study arms, after adjusting for baseline pain score and headache medication use.
Statistical Test of Hypothesis P-Value 0.028
Comments [Not Specified]
Method Mixed Models Analysis
Comments Proportion of headaches with light sensitivity after 2 hours modeled as a function of study arm, baseline pain score and headache medication use.
10.Post-Hoc Outcome
Title Number of Headaches With Associated Light Sensitivity After 4 Hours (All Headaches)
Hide Description Number of headaches with associated light sensitivity after elapsed time of 4 hours following application of the device, based on all migraine headaches experienced by study subjects (i.e. baseline pain score of 2 or higher). Pain scale is an 11-point scale, with integer values from 0 (no pain) to 10 (worst pain imaginable) inclusive.
Time Frame from baseline to 4 hours after device application
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Avulux® Device Control/Sham Device
Hide Arm/Group Description:

Subjects will be instructed to use the glasses for four weeks. They will be instructed to put the glasses on at the first signs or symptoms consistent with the onset of a migraine attack or at the first onset of aura and keep the glasses on until their headache has resolved.

11-point pain scale: Subjects will be asked to rate their headache pain using an 11-point scale, i.e. on an integer scale from 0 to 10 inclusive, with 0 indicating no pain and 10 indicating the worst pain imaginable.

Headache diary: Subjects will be asked to record specific information for all migraine headaches (baseline pain score of 2 or greater) that they experience while enrolled in the study.

Avulux®: Avulux® device

Subjects will be instructed to use the glasses for four weeks. They will be instructed to put the glasses on at the first signs or symptoms consistent with the onset of a migraine attack or at the first onset of aura and keep the glasses on until their headache has resolved.

11-point pain scale: Subjects will be asked to rate their headache pain using an 11-point scale, i.e. on an integer scale from 0 to 10 inclusive, with 0 indicating no pain and 10 indicating the worst pain imaginable.

Headache diary: Subjects will be asked to record specific information for all migraine headaches (baseline pain score of 2 of greater) that they experience while enrolled in the study.

Sham Avulux®: Sham Avulux®

Overall Number of Participants Analyzed 38 40
Overall Number of Units Analyzed
Type of Units Analyzed: Headaches
84 86
Count of Units
Unit of Measure: headaches
24
  28.6%
34
  39.5%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Avulux® Device, Control/Sham Device
Comments Null hypothesis is that proportion of headaches with light sensitivity experienced after 4 hours is equivalent between study arms, after adjusting for baseline pain score and headache medication use.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.46
Comments [Not Specified]
Method Mixed Models Analysis
Comments Proportion of headaches with light sensitivity after 4 hours modeled as a function of study arm, baseline pain score and headache medication use.
Time Frame 4 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Avulux® Device Control/Sham Device
Hide Arm/Group Description

Subjects will be instructed to use the glasses for four weeks. They will be instructed to put the glasses on at the first signs or symptoms consistent with the onset of a migraine attack or at the first onset of aura and keep the glasses on until their headache has resolved.

11-point pain scale: Subjects will be asked to rate their headache pain using an 11-point scale, i.e. on an integer scale from 0 to 10 inclusive, with 0 indicating no pain and 10 indicating the worst pain imaginable.

Headache diary: Subjects will be asked to record specific information for the first (and all subsequent) severe or very severe migraine headaches that they experience while enrolled in the study.

Avulux®: Avulux® device

Subjects will be instructed to use the glasses for four weeks. They will be instructed to put the glasses on at the first signs or symptoms consistent with the onset of a migraine attack or at the first onset of aura and keep the glasses on until their headache has resolved.

11-point pain scale: Subjects will be asked to rate their headache pain using an 11-point scale, i.e. on an integer scale from 0 to 10 inclusive, with 0 indicating no pain and 10 indicating the worst pain imaginable.

Headache diary: Subjects will be asked to record specific information for the first (and all subsequent) severe or very severe migraine headaches that they experience while enrolled in the study.

Sham Avulux®: Sham Avulux®

All-Cause Mortality
Avulux® Device Control/Sham Device
Affected / at Risk (%) Affected / at Risk (%)
Total   0/38 (0.00%)      0/40 (0.00%)    
Hide Serious Adverse Events
Avulux® Device Control/Sham Device
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/38 (0.00%)      0/40 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Avulux® Device Control/Sham Device
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/38 (2.63%)      0/40 (0.00%)    
Gastrointestinal disorders     
vomiting   1/38 (2.63%)  1 0/40 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Difficulty breathing   1/38 (2.63%)  1 0/40 (0.00%)  0
Skin and subcutaneous tissue disorders     
Hives   1/38 (2.63%)  1 0/40 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Institution can independently publish 12 months from completion of the Study. Investigator shall submit the manuscript of any proposed publication to Sponsor at least 30 days before publication, and Sponsor shall have the right to review and comment upon the manuscript in order to protect Sponsor's Confidential Information. Upon Sponsor's request, publication shall be delayed up to 90 additional days.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Charles Posternack, President
Organization: Avulux
Phone: 833-288-5890
EMail: cposternack@avulux.com
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Responsible Party: Avulux, Inc.
ClinicalTrials.gov Identifier: NCT04341298    
Other Study ID Numbers: 20200480
First Submitted: April 8, 2020
First Posted: April 10, 2020
Results First Submitted: January 25, 2022
Results First Posted: January 9, 2023
Last Update Posted: January 9, 2023