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A Study With Lu AG09222 in Adults With Migraine Who Have Not Been Helped by Prior Preventive Treatments

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ClinicalTrials.gov Identifier: NCT05133323
Recruitment Status : Completed
First Posted : November 24, 2021
Results First Posted : February 8, 2024
Last Update Posted : March 13, 2024
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Migraine
Interventions Drug: Lu AG09222
Drug: Placebo
Enrollment 237
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lu AG09222 High Dose Lu AG09222 Low Dose Placebo
Hide Arm/Group Description Participants received a single dose of Lu AG09222 by intravenous (IV) infusion. Participants received a single dose of Lu AG09222 by IV infusion. Participants received a single dose of placebo matching to Lu AG09222 by IV infusion.
Period Title: Overall Study
Started 97 46 94
Received at Least 1 Dose of Study Drug 97 46 94
Completed 95 45 93
Not Completed 2 1 1
Reason Not Completed
Lack of Efficacy             0             0             1
Withdrawal by Subject             2             1             0
Arm/Group Title Lu AG09222 High Dose Lu AG09222 Low Dose Placebo Total
Hide Arm/Group Description Participants received a single dose of Lu AG09222 by intravenous (IV) infusion. Participants received a single dose of Lu AG09222 by IV infusion. Participants received a single dose of placebo matching to Lu AG09222 by IV infusion. Total of all reporting groups
Overall Number of Baseline Participants 97 46 94 237
Hide Baseline Analysis Population Description
The all-participants-treated set (APTS) represents all randomized participants who received an infusion of investigational medicinal product
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 97 participants 46 participants 94 participants 237 participants
42.5  (9.88) 42.5  (9.35) 42.5  (9.51) 42.5  (9.59)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 97 participants 46 participants 94 participants 237 participants
Female
89
  91.8%
38
  82.6%
81
  86.2%
208
  87.8%
Male
8
   8.2%
8
  17.4%
13
  13.8%
29
  12.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 97 participants 46 participants 94 participants 237 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
97
 100.0%
46
 100.0%
94
 100.0%
237
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Change From Baseline in the Number of Monthly Migraine Days (MMDs)
Hide Description

The Migraine Day definition was based on the International Headache Society (IHS) guidelines for controlled trials of preventive treatment of chronic migraine and episodic migraine in adults. A Migraine Day was defined as a day with a headache that:

  • lasts ≥4 hours and meets International Classification of Headache Disorders Third Edition (ICHD-3) guidelines criteria C and D for migraine without aura
  • or lasts ≥30 minutes and where the participant had an aura with the headache (migraine with aura),
  • or lasts ≥30 minutes and meets two of the three ICHD-3 criteria B (without the condition on 72 hours), C and D for migraine without aura (probable migraine),
  • or a day with a headache that is successfully treated with a triptan, ergotamine, or other migraine-specific acute medication
Time Frame Baseline, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
The APTS represents all randomized participants who received an infusion of investigational medicinal product
Arm/Group Title Lu AG09222 High Dose Lu AG09222 Low Dose Placebo
Hide Arm/Group Description:
Participants received a single dose of Lu AG09222 by intravenous (IV) infusion.
Participants received a single dose of Lu AG09222 by IV infusion.
Participants received a single dose of placebo matching to Lu AG09222 by IV infusion.
Overall Number of Participants Analyzed 97 46 94
Least Squares Mean (Standard Error)
Unit of Measure: days
-6.2  (0.66) -6.0  (0.94) -4.2  (0.67)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lu AG09222 High Dose, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0106
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.0
Confidence Interval (1-Sided) 90%
-0.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.89
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With ≥50% Reduction From Baseline in MMDs
Hide Description

The Migraine Day definition was based on the International Headache Society (IHS) guidelines for controlled trials of preventive treatment of chronic migraine and episodic migraine in adults. A Migraine Day was defined as a day with a headache that:

  • lasts ≥4 hours and meets International Classification of Headache Disorders Third Edition (ICHD-3) guidelines criteria C and D for migraine without aura
  • or lasts ≥30 minutes and where the participant had an aura with the headache (migraine with aura),
  • or lasts ≥30 minutes and meets two of the three ICHD-3 criteria B (without the condition on 72 hours), C and D for migraine without aura (probable migraine),
  • or a day with a headache that is successfully treated with a triptan, ergotamine, or other migraine-specific acute medication
Time Frame Baseline, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
The APTS represents all randomized participants who received an infusion of investigational medicinal product
Arm/Group Title Lu AG09222 High Dose Lu AG09222 Low Dose Placebo
Hide Arm/Group Description:
Participants received a single dose of Lu AG09222 by intravenous (IV) infusion.
Participants received a single dose of Lu AG09222 by IV infusion.
Participants received a single dose of placebo matching to Lu AG09222 by IV infusion.
Overall Number of Participants Analyzed 97 46 94
Measure Type: Number
Unit of Measure: percentage of participants
32.2 36.1 26.8
3.Secondary Outcome
Title Change From Baseline in the Number of Monthly Headache Days (MHDs)
Hide Description A Headache Day was defined as a day with a headache that lasted ≥30 minutes or that meets the definition of a Migraine Day.
Time Frame Baseline, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
The APTS represents all randomized participants who received an infusion of investigational medicinal product. Here, 'Number of participants analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title Lu AG09222 High Dose Lu AG09222 Low Dose Placebo
Hide Arm/Group Description:
Participants received a single dose of Lu AG09222 by intravenous (IV) infusion.
Participants received a single dose of Lu AG09222 by IV infusion.
Participants received a single dose of placebo matching to Lu AG09222 by IV infusion.
Overall Number of Participants Analyzed 96 44 93
Least Squares Mean (Standard Error)
Unit of Measure: days
-5.8  (0.65) -5.9  (0.93) -4.1  (0.67)
Time Frame Up to 12 weeks
Adverse Event Reporting Description The APTS represents all randomized participants who received an infusion of investigational medicinal product
 
Arm/Group Title Lu AG09222 High Dose Lu AG09222 Low Dose Placebo
Hide Arm/Group Description Participants received a single dose of Lu AG09222 by intravenous (IV) infusion. Participants received a single dose of Lu AG09222 by IV infusion. Participants received a single dose of placebo matching to Lu AG09222 by IV infusion.
All-Cause Mortality
Lu AG09222 High Dose Lu AG09222 Low Dose Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/97 (0.00%)      0/46 (0.00%)      0/94 (0.00%)    
Hide Serious Adverse Events
Lu AG09222 High Dose Lu AG09222 Low Dose Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/97 (1.03%)      0/46 (0.00%)      0/94 (0.00%)    
Musculoskeletal and connective tissue disorders       
Sympathetic Posterior Cervical Syndrome † 1  1/97 (1.03%)  1 0/46 (0.00%)  0 0/94 (0.00%)  0
1
Term from vocabulary, MedDRA v25.0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lu AG09222 High Dose Lu AG09222 Low Dose Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   18/97 (18.56%)      4/46 (8.70%)      8/94 (8.51%)    
General disorders       
Fatigue † 1  5/97 (5.15%)  5 2/46 (4.35%)  2 1/94 (1.06%)  1
Infections and infestations       
Covid-19 † 1  7/97 (7.22%)  7 2/46 (4.35%)  2 3/94 (3.19%)  3
Nasopharyngitis † 1  7/97 (7.22%)  7 0/46 (0.00%)  0 4/94 (4.26%)  5
1
Term from vocabulary, MedDRA v25.0
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Email contact via
Organization: H. Lundbeck A/S
Phone: +4536301311
EMail: LundbeckClinicalTrials@Lundbeck.com
Layout table for additonal information
Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT05133323    
Other Study ID Numbers: 19678A
First Submitted: November 15, 2021
First Posted: November 24, 2021
Results First Submitted: January 15, 2024
Results First Posted: February 8, 2024
Last Update Posted: March 13, 2024