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

Amgen

Status and phase: Completed; Phase 1

Conditions: Migraine

Treatments: Drug: PACAP-38 Challenge Agent; Drug: Erenumab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02542605

20140207

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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35 participants in 3 patient groups, including a placebo group

PACAP-38 Challenge Agent

Other group

Description:

In Part A, 4 cohorts of 2 to 5 participants sequentially received an intravenous infusion of 10 picomol/kilogram/minute (pmol/kg/minute) PACAP-38 for 2.5, 5, 7.5 and 10 minutes each in order to determine the dose for Part B.

Treatment:

Drug: PACAP-38 Challenge Agent

Placebo

Placebo Comparator group

Description:

Participants were randomized to receive matching erenumab placebo by intravenous administration over 30 minutes on day 1. On day 8 participants were administered the dose of PACAP-38 determined from Part A of the study (100 pmol/kg) and were followed up for 11 weeks.

Treatment:

Drug: Placebo

Drug: PACAP-38 Challenge Agent

Erenumab

Experimental group

Description:

Participants were randomized to receive 140 milligrams (mg) erenumab by intravenous administration over 30 minutes on day 1 in Part B. On day 8 participants were administered the dose of PACAP-38 determined from Part A of the study (100 pmol/kg) and were followed up for 11 weeks.

Treatment:

Drug: Erenumab

Drug: PACAP-38 Challenge Agent