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

Completed · Phase 1 · Has a placebo group

Conditions studied: Migraine

In brief

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.

Key facts

Study ID

NCT02542605

Run by

Amgen

People needed

35

Starts

2015-11-11

Expected to finish

2017-11-08

Last updated by the study team

2019-06-03

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Research Site — Anaheim, California, United States
• Research Site — Leuven, Belgium
• Research Site — Leiden, Netherlands

Full record on ClinicalTrials.gov

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