A Multicenter Assessment of ALD403 in Chronic Migraine

Study Overview
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Brief Summary
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The purpose of this study is to assess ALD403 in the prevention of migraine headache in chronic migraineurs.

Official Title
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A Parallel Group, Double-Blind, Randomized, Placebo Controlled, Dose-Ranging Phase 2 Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of ALD403 Administered Intravenously in Patients With Chronic Migraine

Conditions
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Migraine Disorders

Intervention / Treatment
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* Biological: ALD403
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of migraine at ≤ 35 years of age with history of chronic migraine ≥ 1 year During the 28 day screening period, must have ≥ 15 headache days of which ≥ 8 days were assessed as migraine days with at least 5 migraine attacks as recorded in the eDiary Headache eDiary was completed on at least 22 of the 28 days prior to randomization Exclusion Criteria: Confounding pain syndromes (e.g. fibromyalgia, chronic low back pain, complex regional pain syndrome) or any pain syndrome that requires regular analgesia Psychiatric conditions that are uncontrolled and untreated, including conditions that are not controlled for a minimum of 6 months prior to screening. History or diagnosis of complicated migraine (ICHD-III beta version, 2013), chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, migraine with brainstem aura, sporadic and familial hemiplegic migraine Unable to differentiate migraine from other headaches Subject has received botulinum toxin for migraine or for any other medical/cosmetic reasons requiring injections in the head, face, or neck within 4 months prior to screening. Have any clinically significant concurrent medical condition Receipt of any monoclonal antibody treatment within 6 months of screening (within or outside a clinical trial) Previously dosed with ALD403 or any monoclonal antibody targeting the CGRP pathway

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALD403 Dose Level 1<br>ALD403 Dose Level 1 (IV) | Biological: ALD403<br> <br> * Other names: Vyepti;|
| Experimental: ALD403 Dose Level 2<br>ALD403 Dose Level 2 (IV) | Biological: ALD403<br> <br> * Other names: Vyepti;|
| Experimental: ALD403 Dose Level 3<br>ALD403 Dose Level 3 (IV) | Biological: ALD403<br> <br> * Other names: Vyepti;|
| Experimental: ALD403 Dose Level 4<br>ALD403 Dose Level 4 (IV) | Biological: ALD403<br> <br> * Other names: Vyepti;|
| Placebo Comparator: Placebo<br>Placebo (IV) | Biological: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 75% Migraine Responder Rate | Participants with an average reduction in migraine days of at least 75% over Weeks 1 to 12, as compared with baseline. | 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 50% Migraine Responder Rate | Participants with an average reduction in migraine days of at least 50% over Weeks 1 to 12, as compared with baseline | Weeks 1-12 | 
| 50% Headache Responder Rate | Participants with an average reduction in headache days of at least 50% over Weeks 1 to 12, as compared with baseline | Weeks 1-12 | 
| 100% Headache Responder Rate | Participants with an average reduction in headache days of at least 100% over Weeks 1 to 12, as compared with baseline | Weeks 1-12 | 
| 100% Migraine Responder Rate | Participants with an average reduction in migraine days of at least 100% over Weeks 1 to 12, as compared with baseline | Weeks 1-12 | 
| The Change From Baseline in Monthly Headache Days, Weeks 1-12 | Monthly headache days, as measured by eDiary. 4-weekly intervals averaged across weeks 1-12. | Weeks 1-12 | 
| The Change From Baseline in Monthly Migraine Days, Weeks 1-12 | Monthly migraine days, as measured by eDiary. 4-weekly intervals averaged across weeks 1-12. | Weeks 1-12 | 
| Change From Baseline in Percentage of Severe Migraines | The change from baseline in percentage of migraines that are classified as severe over Weeks 1-12 | Weeks 1-12 | 
| Change From Baseline in Percentage of Severe Headaches | The change from baseline in percentage of headaches that are classified as severe over Weeks 9-12 | Weeks 9-12 | 
| The Change From Baseline to Week 12 in HIT-6 Total Score | The HIT-6 measures the impact of headache on the participant's functional health and well-being in 6 domains: pain; role functioning (ability to carry out usual activities); social functioning; energy or fatigue; cognition; and emotional distress assessed over the prior 12-week period. The total possible scores range from 36 (no impact) to 78 (worst impact). A score of 60 or above is labeled as severe. | Baseline to 12 | 
| Percent Change From Baseline in Headache Days | Monthly headache days, as measured by eDiary. 4-weekly intervals averaged across weeks 1-12. | Weeks 1-12 | 
| Percent Change From Baseline in Migraine Days | Monthly migraine days, as measured by eDiary. 4-weekly intervals averaged across weeks 1-12. | Weeks 1-12 | 
| Time to First Migraine After Dosing | The median number of days after dosing a participant had the next migraine using the eDiary as the recall method | Baseline to Week 49 (End of Study) | 
| Change From Baseline in Monthly Migraine Attacks, Weeks 1-12 | The number of monthly migraine attacks summarized over Weeks 1-12. A migraine attack is defined as 1 continuously recorded migraine. One attack may result in multiple migraine days | Weeks 1-12 | 
| Change From Baseline in Monthly Headache Episodes, Weeks 1-12 | The number of monthly headache episodes as summarized over Weeks 1-12. A headache episode is defined as 1 continuously recorded headache. One episode may result in multiple headache days | Weeks 1-12 | 
| Change From Baseline in Monthly Migraine Hours, Weeks 1-12 | Migraine hours are the sum of the duration of migraines within 4 week intervals, and the average 4 week duration within 12 week intervals. | Weeks 1-12 | 
| Change From Baseline in Monthly Headache Hours, Weeks 1-12 | Headache hours are the sum of the duration of headaches within 4 week intervals, and the average 4 week duration within 12 week intervals. | Weeks 1-12 | 
| Change From Baseline to Weeks 9-12 in Percentage of Migraines With Use of Acute Medication | The percent of migraines with acute medication usage. Participants with no migraines will be included with a rate of zero. | Weeks 9-12 | 
| Change From Baseline to Weeks 9-12 in Percentage of Headaches With Use of Acute Medication | The percent of headaches with acute medication usage. Participants with no headaches will be included with a rate of zero. | Weeks 9-12 | 
| Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 | The SF-36 is a health survey containing 36 questions consisting of eight scaled scores to measure quality of life over the past 4 weeks (range: 0=worst to 100=best). Increases from baseline indicate improvement. | Baseline to Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Migraine Disorders, ALD403