A Multicenter Assessment of ALD403 in Chronic Migraine

Phase 2CompletedNCT02275117

Alder Biopharmaceuticals, Inc.665 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

665

Conditions

Migraine Disorders

Interventions

ALD403BIOLOGICAL

PlaceboBIOLOGICAL

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Locations (92)

Outcomes

Primary Outcomes

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.

Time frame: 12 Weeks

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: Weeks 1-12

Change From Baseline in Percentage of Severe Migraines

Data from ClinicalTrials.gov

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Research Site

Huntsville, Alabama, United States

Research Site

Mobile, Alabama, United States

Research Site

Phoenix, Arizona, United States

Research Site

Scottsdale, Arizona, United States

Research Site

Hot Springs, Arkansas, United States

Research Site

Little Rock, Arkansas, United States

Research Site

Anaheim, California, United States

Research Site

Encino, California, United States

Reserach Site

Long Beach, California, United States

Research Site

Los Angeles, California, United States

...and 82 more locations

The change from baseline in percentage of migraines that are classified as severe over Weeks 1-12

Time frame: 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

Time frame: 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".

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline to Week 12