A Multicenter Assessment of ALD403 in Frequent Episodic Migraine

• Status: Completed
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alder Biopharmaceuticals, Inc.

Criteria

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