A Multicenter Assessment of ALD403 in Chronic Migraine

Phase 2

Completed

Conditions: Migraine Disorders

Interventions: Biological: ALD403
Biological: Placebo

Registration Number: NCT02275117

Lead Sponsor: Alder Biopharmaceuticals, Inc.

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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 665

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ALD403 Dose Level 3	ALD403	ALD403 Dose Level 3 (IV)
ALD403 Dose Level 4	ALD403	ALD403 Dose Level 4 (IV)
ALD403 Dose Level 2	ALD403	ALD403 Dose Level 2 (IV)
ALD403 Dose Level 1	ALD403	ALD403 Dose Level 1 (IV)
Placebo	Placebo	Placebo (IV)

Primary Outcome Measures

Name	Time	Method
75% Migraine Responder Rate	12 Weeks	Participants with an average reduction in migraine days of at least 75% over Weeks 1 to 12, as compared with baseline.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Monthly Headache Episodes, Weeks 1-12	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
Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12	Baseline to 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.
Change From Baseline in Monthly Migraine Attacks, Weeks 1-12	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
100% Migraine Responder Rate	Weeks 1-12	Participants with an average reduction in migraine days of at least 100% over Weeks 1 to 12, as compared with baseline
The Change From Baseline in Monthly Headache Days, Weeks 1-12	Weeks 1-12	Monthly headache days, as measured by eDiary. 4-weekly intervals averaged across weeks 1-12.
Percent Change From Baseline in Migraine Days	Weeks 1-12	Monthly migraine days, as measured by eDiary. 4-weekly intervals averaged across weeks 1-12.
50% Migraine Responder Rate	Weeks 1-12	Participants with an average reduction in migraine days of at least 50% over Weeks 1 to 12, as compared with baseline
50% Headache Responder Rate	Weeks 1-12	Participants with an average reduction in headache days of at least 50% over Weeks 1 to 12, as compared with baseline
100% Headache Responder Rate	Weeks 1-12	Participants with an average reduction in headache days of at least 100% over Weeks 1 to 12, as compared with baseline
The Change From Baseline in Monthly Migraine Days, Weeks 1-12	Weeks 1-12	Monthly migraine days, as measured by eDiary. 4-weekly intervals averaged across weeks 1-12.
Percent Change From Baseline in Headache Days	Weeks 1-12	Monthly headache days, as measured by eDiary. 4-weekly intervals averaged across weeks 1-12.
Change From Baseline in Percentage of Severe Migraines	Weeks 1-12	The change from baseline in percentage of migraines that are classified as severe over Weeks 1-12
Time to First Migraine After Dosing	Baseline to Week 49 (End of Study)	The median number of days after dosing a participant had the next migraine using the eDiary as the recall method
Change From Baseline to Weeks 9-12 in Percentage of Migraines With Use of Acute Medication	Weeks 9-12	The percent of migraines with acute medication usage. Participants with no migraines will be included with a rate of zero.
Change From Baseline to Weeks 9-12 in Percentage of Headaches With Use of Acute Medication	Weeks 9-12	The percent of headaches with acute medication usage. Participants with no headaches will be included with a rate of zero.
Change From Baseline in Percentage of Severe Headaches	Weeks 9-12	The change from baseline in percentage of headaches that are classified as severe over Weeks 9-12
The Change From Baseline to Week 12 in HIT-6 Total Score	Baseline to 12	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".
Change From Baseline in Monthly Headache Hours, Weeks 1-12	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.
Change From Baseline in Monthly Migraine Hours, Weeks 1-12	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.