A Multicenter Assessment of ALD403 in Frequent Episodic Migraine

Phase 3CompletedNCT02559895

Alder Biopharmaceuticals, Inc.898 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

898

Conditions

Migraine Disorders

Interventions

ALD403DRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of migraine at ≤ 50 years of age (ICHD-II, 2004 Section 1) * History of migraine ≥ 12 months with * ≤ 14 headache days of which at least 4 have to be migraine days (migraine days count as headache days) in each 28 day period in the 3 months prior to screening * During the 28 days following the screening visit, the subject experiences ≤ 14 headache days of which at least 4 have to be migraine days (migraine days count as headache days) as recorded in the eDiary * No use of any botulinum toxin for migraine or for any other medical/cosmetic reasons requiring injections in the head, face, or neck 4 months prior to screening and during the 28 day period prior to randomization * Headache eDiary was completed on at least 25 of the 28 days prior to randomization Exclusion Criteria: * Confounding pain syndromes, e.g. fibromyalgia, 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- II, 2004 Section 1), 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 * 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 (87)

Outcomes

Primary Outcomes

Change From Baseline in Monthly Migraine Days (Weeks 1-12)

Monthly migraine days are summarized in 28-day intervals, and averaged across Weeks 1-12

Time frame: Week 1-12

Secondary 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: Week 1-12

75% Migraine Responder Rate

Participants with an average reduction in migraine days of at least 75% over Weeks 1 to 4, as compared with baseline.

Time frame: Week 1-4

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: Week 1-12

Percentage of Participants With a Migraine on the Day After Dosing

The percentage of participants with a migraine on the day after dosing, where Day 0 is treatment day and Day 1 is the day after dosing

Time frame: 1 day

75% Headache Responder Rate

Participants with an average reduction in headache days of at least 75% over Weeks 1 to 12, as compared with baseline.

Time frame: Week 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: Week 1-12

Data from ClinicalTrials.gov

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Research Site

Birmingham, Alabama, United States

Research Site

Phoenix, Arizona, United States

Research Site

Tucson, Arizona, United States

Research Site

Little Rock, Arkansas, United States

Research Site

Anaheim, California, United States

Research Site

Fresno, California, United States

Research Site

Fullerton, California, United States

Research Site

Long Beach, California, United States

Research Site

Montclair, California, United States

Research Site

Oceanside, California, United States

...and 77 more locations

100% Migraine Responder Rate

Participants with a reduction in migraine days of 100% over Weeks 1 to 12, as compared with baseline

Time frame: Week 1-12

100% Headache Responder Rate

Participants with a reduction in headache days of 100% over Weeks 1 to 12, as compared with baseline.

Time frame: Week 1-12

Change From Baseline in Acute Migraine Medication Days (Weeks 1-12)

The change in number of days with any triptan or ergotamine use as recorded in the eDiary.

Time frame: Week 1-12

Change From Baseline in Average Daily Migraine Prevalence to Week 4

The change in the percentage of days where a participant has a migraine from baseline to Week 4.

Time frame: Baseline to Week 4

Change From Baseline to Week 12 in Percentage of Migraines With Use of Acute Medication

The percentage of migraines with acute medication usage. Participants with no migraines will be included with a rate of zero.

Time frame: Week 1-12

Change From Baseline to Week 12 in Percentage of Headaches With Use of Acute Medication

The percentage of headaches with acute medication usage. Participants with no headaches will be included with a rate of zero.

Time frame: Week 1-12

Change From Baseline in Monthly Headache Days (Weeks 1-12)

Monthly headache days are summarized in 28-day intervals, and averaged across Weeks 1-12.

Time frame: Week 1-12

Percent of Headaches With Severe Intensity

Summary of percent of headaches with severe intensity over Weeks 1-12.

Time frame: Week 1-12

Percent of Migraines With Severe Intensity

Summary of percent of migraines with severe intensity over Week 1-12.

Time frame: Week 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: Week 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: Week 1-12

Change From Baseline of Short Form Health Survey (SF-36 v 2.0) Scale Scores

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. All scales are on a range of 0 to 100, with 0 being the worst and 100 being the best. Scales are reported separately. Increases from baseline indicate improvement.

Time frame: Baseline to Week 12

Health Related Quality of Life (EQ-5D-5L) at Week 12

The EQ-5D-5L is a descriptive system of health-related quality of life states consisting of 5 dimension/questions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses. The responses record five levels of severity (no problems/slight problems/moderate problems/severe problems/extreme problems) within a particular EQ-5D dimension.

Time frame: Week 12

Change in Baseline of Allodynia Symptom Checklist-12 (ASC-12) Total Score

The ASC-12 includes 12 questions about the frequency of various allodynia symptoms in association with headache attacks. For individuals with more than one type of headache, questions are directed to the "most severe type of headache." Each item is measured in a Likert type scale option with response categories: "Does not apply to me", "never", "rarely", "less than half the time", and "half the time or more". ASC items were scored as 0 (i.e., never, rarely or does not apply to me), 1 (less than half the time), and 2 (half the time or more), yielding scores that ranged from 0 to 24. If a single item is missing, it is scored as a 0. If more than one item is missing the total score will be missing. The interpretation of the total score is, 0-2: none; 3-5: mild; 6-8: moderate; greater than or equal to 9: severe.

Time frame: Baseline to Week 12