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

Completed

Conditions: migraine
10019231

Registration Number: NL-OMON45872

Lead Sponsor: Amgen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

* 18 to * 45 years of age at time of screening.
Migraine headaches without aura * 6 months prior to screening.
* 1 and * 5 migraine days per month in each of the 3 months prior to screening.

Exclusion Criteria

History of migraine with aura, cluster headachte or hemiplegic migraine headache.
Other headache disorders (except for episodic tension-type headache <5days/month.
Recent nicotine or tobacco users (should have stopped approximately 6 months prior to screening).
Pregnant or breastfeeding women.
More exclusion criteria can be found on page 33 to 36 of the protocol amendment 4 dd 21Oct16

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Occurrence of a migraine-like attack within 24 hours of challenge-agent<br /><br>infusion</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary Endpoints:<br /><br>* Occurrence of a headache within 24 hours of challenge-agent infusion<br /><br>* Treatment-emergent adverse events<br /><br>* Clinical significant changes in vital signs, ECGs, physical examinations,<br /><br>laboratory safety tests and neurological assessments<br /><br>* AMG 334 PK parameters, including C1 hour and AUC84d<br /><br>* Anti-AMG 334 antibodies<br /><br><br /><br>Exploratory Endpoints:<br /><br>* Severity of PACAP-38 induced migraine-like attacks and headaches<br /><br>* Duration of PACAP-38 induced migraine-like attacks and headaches<br /><br>* Migraine characteristics: localization, accompanying symptoms and<br /><br>pre-monitory symptoms.<br /><br>* PACAP-38 related treatment-emergent adverse events<br /><br>* Evaluate the concentration of PACAP-38 and CGRP following administration of<br /><br>AMG 334</p><br>