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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.

Tracking Information
First Submitted Date  ICMJE April 8, 2020
First Posted Date  ICMJE April 10, 2020
Results First Submitted Date  ICMJE January 25, 2022
Results First Posted Date  ICMJE January 9, 2023
Last Update Posted Date January 9, 2023
Actual Study Start Date  ICMJE April 6, 2020
Actual Primary Completion Date August 26, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 11, 2022)
Change in 11-point Pain Scale Score After Two Hours (First Severe Headache) [ Time Frame: from baseline to 2 hours after device application ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 9, 2020)
11-point pain scale total score at two hours [ Time Frame: 2 hours ]
The primary objective of this study is to evaluate the efficacy of the Avulux® device in reducing the impact of migraine headaches, as measured by improvement in an 11-point pain scale after 2 hours of device application, when compared to a control/sham device.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2022)
Change in 11-point Pain Scale Score After Four Hours (First Severe Headache) [ Time Frame: from baseline to four hours after device application ]
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2020)
11-point pain scale total score at four hours [ Time Frame: four hours ]
The secondary objective of this study is to evaluate the efficacy of the Avulux® device in reducing the impact of migraine headaches, as measured by improvement in an 11-point pain scale after 4 hours of device application, when compared to a control/sham device.
Current Other Pre-specified Outcome Measures
 (submitted: April 11, 2022)
  • Number of Subjects With Quantifiable Improvement in Pain Score After Two Hours (First Severe Headache) [ Time Frame: from baseline to 2 hours after device application ]
    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.
  • Number of Subjects Who Require the Use of Abortive Medications (First Severe Headache) [ Time Frame: baseline to 8 hours after device application ]
    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.
  • Number of Subjects Suffering From Light Sensitivity After 2 Hours (First Severe Headache) [ Time Frame: 2 hours after device application ]
    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.
  • Number of Subjects Suffering From Light Sensitivity After 4 Hours (First Severe Headache) [ Time Frame: 4 hours after device application ]
    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.
Original Other Pre-specified Outcome Measures
 (submitted: April 9, 2020)
  • Quantifiable improvement in overall migraine impact [ Time Frame: 2 hours ]
    To compare the proportion of subjects who show quantifiable improvement in overall migraine impact, as measured by a change in migraine pain from severe to mild/no pain (defined as a pain score of 3 or less), when using the Avulux® device vs. control/sham device after an elapsed time of 2 hours following application of the device.
  • Proportion of subjects who require the use of abortive medications when using the Avulux® device vs. the control/sham device. [ Time Frame: 8 hours ]
    To compare the proportion of subjects who require abortive medication to control their first severe or very severe migraine headache within 8 hours following application of the Avulux® device vs. control/sham device.
  • Proportion of subjects suffering from light sensitivity as a result of their migraine headache [ Time Frame: 2 hours and 4 hours ]
    To compare the proportion of subjects suffering from light sensitivity after elapsed times of 2 hours and 4 hours as a result of their migraine headache when using the Avulux® device vs. control/sham device.
 
Descriptive Information
Brief Title  ICMJE Use of the Avulux® Lenses as an Aid in Reducing the Impact of Migraine Headaches
Official Title  ICMJE Clinical Evaluation of Avulux® Lenses as an Aid in Reducing the Impact of Migraine Headaches
Brief Summary The purpose of this research is to assess how well the Avulux® migraine lenses work in reducing the impact of migraine headaches as measured by improvement in an 11-point pain scale after two and four hours of device application, when compared to a control device.
Detailed Description

Avulux® is intended to reduce the severity of headache pain in adult patients diagnosed with episodic migraine headaches. In this study, the investigative Avulux® device shall consist of a pair of optical filters in the form of spectacle lenses, provided in a standard spectacle frame; the lenses contain a dye that effectively blocks light at specified wavelength ranges while minimizing distortion of the visible spectrum. The optical filters block a portion of the optical spectrum that is suspected to stimulate photophobic responses that trigger some, and exacerbate most, migraines.

The control/sham device for this study shall be a pair of plastic lenses provided in a standard spectacle frame, which will have negligible light-blocking properties at the optical wavelengths which are blocked by the Avulux® device.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
A minimum of 68 subjects will be randomized in to one of two treatment groups in a one-to-one ratio.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:

In this study, the investigative Avulux® device shall consist of a pair of optical filters in the form of spectacle lenses, provided in a standard spectacle frame; the lenses contain a dye that effectively blocks light at specified wavelength ranges while minimizing distortion of the visible spectrum. The optical filters block a portion of the optical spectrum that is suspected to stimulate photophobic responses that trigger some, and exacerbate most, migraines.

The control/sham device for this study shall be a pair of plastic lenses provided in a standard spectacle frame, which will have negligible light-blocking properties at the optical wavelengths which are blocked by the Avulux® device.

Primary Purpose: Treatment
Condition  ICMJE Migraine
Intervention  ICMJE
  • Other: 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.
  • Other: 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.
  • Device: Avulux®
    Avulux® device
  • Device: Sham Avulux®
    Sham Avulux®
Study Arms  ICMJE
  • Experimental: 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.
    Interventions:
    • Other: 11-point pain scale
    • Other: Headache diary
    • Device: Avulux®
  • Sham Comparator: Control/sham 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.
    Interventions:
    • Other: 11-point pain scale
    • Other: Headache diary
    • Device: Sham Avulux®
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 11, 2022)
78
Original Estimated Enrollment  ICMJE
 (submitted: April 9, 2020)
68
Actual Study Completion Date  ICMJE August 26, 2020
Actual Primary Completion Date August 26, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject is 18 years or older
  • Subject is willing and able to provide written informed consent
  • Diagnosis of migraine, based on a history of at least 5 attacks per month with the following primary headache characteristics:

    • Headache attacks lasting 4-72 hours (untreated or unsuccessfully treated)
    • Headache has at least two of the following characteristics:

      • unilateral location
      • pulsating quality
      • moderate or severe pain intensity
      • aggravation by or causing avoidance of routine physical activity (e.g. walking or climbing stairs)
    • Headache occurs with at least one of the following symptoms:

      • nausea and/or vomiting
      • photophobia and phonophobia
  • Subject has experienced at least 4 migraine attacks in the last month, with at least two migraine attacks resulting in severe pain prior to the use of any abortive medications
  • Migraines are not attributed to another disorder

Exclusion Criteria:

  • Subjects participating in another prospective, interventional clinical study
  • Subjects with other light sensitive conditions, such as iritis
  • Subjects who have less than 4 headache days per month with the above characteristics
  • Chronic migraine subjects (defined as subjects who experience a minimum of 15 headache days per month)
  • Subjects with headaches due to medication overuse (defined as regular use of headache medication for a minimum of 10 days per month, for a minimum period of 3 months)
  • Subjects who have had any change in their migraine treatment within 4 weeks prior to study enrollment
  • Subjects whose family members are currently participating in this study, or are employees of the study site, Avulux, or the coordinating CRO
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04341298
Other Study ID Numbers  ICMJE 20200480
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Avulux, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Avulux, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Imarc Research, Inc.
Investigators  ICMJE Not Provided
PRS Account Avulux, Inc.
Verification Date April 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP