Phase 2 N=665 Randomized Double-blind Prevention

A Multicenter Assessment of ALD403 in Chronic Migraine

Migraine Disorders

Bottom Line

View on ClinicalTrials.gov: NCT02275117 ↗

Enrolled (actual)

665

Serious AEs

2.1%

Results posted

Mar 2020

Primary outcome: Primary: 75% Migraine Responder Rate — 38; 37; 33; 33 Participants — p=0.0330

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: ALD403 (Biological); Placebo (Biological)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Alder Biopharmaceuticals, Inc.
Primary completion: Mar 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY 75% Migraine Responder Rate	38; 37; 33; 33; 24	0.0330 sig
SECONDARY 50% Migraine Responder Rate	65; 65; 65; 54; 47	—
SECONDARY 50% Headache Responder Rate	59; 55; 55; 48; 39	—
SECONDARY 100% Headache Responder Rate	4; 0; 0; 1; 1	—
SECONDARY 100% Migraine Responder Rate	9; 6; 5; 10; 3	—
SECONDARY The Change From Baseline in Monthly Headache Days, Weeks 1-12	-9.6; -8.9; -9.2; -7.5; -6.9	—
SECONDARY The Change From Baseline in Monthly Migraine Days, Weeks 1-12	-8.2; -7.7; -7.9; -6.7; -5.6	—
SECONDARY Change From Baseline in Percentage of Severe Migraines	-20.7; -15.9; -17.2; -16.1; -9.7	—
SECONDARY Change From Baseline in Percentage of Severe Headaches	-19.91; -10.36; -12.17; -11.42; -6.48	—
SECONDARY The Change From Baseline to Week 12 in HIT-6 Total Score	-60.4; -43.4; -34.9; -34.8; -28.4	—
SECONDARY Percent Change From Baseline in Headache Days	-46.12; -43.09; -44.37; -37.20; -34.02	—
SECONDARY Percent Change From Baseline in Migraine Days	-48.88; -46.79; -46.74; -40.80; -35.37	—
SECONDARY Time to First Migraine After Dosing	4.0; 4.0; 3.0; 4.0; 2.0	—
SECONDARY Change From Baseline in Monthly Migraine Attacks, Weeks 1-12	-6.8; -6.5; -6.9; -6.2; -5.5	—
SECONDARY Change From Baseline in Monthly Headache Episodes, Weeks 1-12	-8.2; -8.0; -8.3; -7.3; -7.0	—
SECONDARY Change From Baseline in Monthly Migraine Hours, Weeks 1-12	-70.9; -64.2; -63.1; -49.2; -34.9	—
SECONDARY Change From Baseline in Monthly Headache Hours, Weeks 1-12	-73.9; -60.9; -62.9; -47.5; -38.7	—
SECONDARY Change From Baseline to Weeks 9-12 in Percentage of Migraines With Use of Acute Medication	-15.43; -10.36; -4.44; -10.03; -9.60	—
SECONDARY Change From Baseline to Weeks 9-12 in Percentage of Headaches With Use of Acute Medication	-5.98; -3.27; 1.52; -3.14; -3.42	—
SECONDARY Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12	50.5; 50.6; 51.1; 50.3; 50.2; 53.6	—

Summary

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

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02275117). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.