To Evaluate the Blockade of CGRP in Preventing PACAP-38 Induced Migraine-like Attacks With AMG 334 in Migraine Patients

• Status: Completed
• Trial end date: 2017-11-08
• Target enrollment: 0
• Participant gender: All

Summary

Phase I, Randomized, Parallel-group, Double-Blind, Placebo-Controlled, Single Dose Study to Evaluate the Blockade of CGRP Receptor by AMG 334 in Preventing PACAP-38 Induced Migraine-like Attacks in Migraine Patients.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Erenumab; Pituitary Adenylate Cyclase-Activating Polypeptide

Criteria

Inclusion Criteria:

• Adults ≥ 18 to ≤ 45 years of age upon entry into screening

• History of migraine headaches without aura for ≥ 6 months prior to screening according to the International Headache Society (IHS) International Classification of Headache Disorders (ICHD-II) (Headache Classification Committee of the International Headache Society, 2004) based on medical records and/or patient self-report

• Migraine frequency: ≥ 1 and ≤ 5 migraine days per month in each of the 3 months prior to screening

Exclusion Criteria:

• History of migraine with aura, cluster headache or hemiplegic migraine headache according to the IHS Classification ICHD-II (Headache Classification Committee of the International Headache Society, 2004) based on medical records and/or patient self-report

• ≥ 6 migraine days per month in the last 3 months prior to study enrollment and during screening period

• Other headache disorders (except for episodic tension-type headache <5 days/month)