This trial is active, not recruiting.

Condition migraine disorders
Treatments ald403, placebo
Phase phase 2
Sponsor Alder Biopharmaceuticals, Inc.
Start date October 2014
End date March 2016
Trial size 617 participants
Trial identifier NCT02275117, ALD403-CLIN-005


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose prevention
ALD403 Dose Level 1 (IV)
ALD403 Dose Level 2 (IV)
ALD403 Dose Level 3 (IV)
ALD403 Dose Level 4 (IV)
(Placebo Comparator)
Placebo (IV)

Primary Outcomes

Change in migraine days from baseline to week 12.
time frame: 12 weeks

Secondary Outcomes

Evaluate safety of ALD403: laboratory variables, ECG and adverse events
time frame: 49 weeks
Cmax - Peak plasma concentration of ALD403
time frame: 49 weeks
Tmax - Time to achieve peak plasma concentration of ALD403
time frame: 49 weeks
AUC - Area under the plasma concentration vs.time curve of ALD403
time frame: 49 weeks

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

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

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Alder Biopharmaceuticals, Inc..