Study Complete
Sponsor ID
20140207
To Evaluate the Blockade of CGRP in Preventing PACAP-38 Induced Migraine-like Attacks with AMG 334 in Migraine Patients
Study Details
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.
Protocol Summary
Primary Outcome Measures
Occurrence of a migraine-like attack within 24 hours of challenge agent infusion
Timeframe: 1 day
Secondary Outcome Measures
Occurrence of a headache within 24 hours of challenge-agent infusion
Timeframe: 1 day
Treatment-emergent adverse events
Timeframe: 85 days
Clinical significant changes in vital signs, electrocardiograms (ECGs), physical examinations, laboratory safety tests and neurological assessments
Timeframe: 85 days
Erenumab pharmacokinetic (PK) parameters, including serum concentration time at 1 hour (C1h) and area under the concentration-time curve from time 0 to 84 days (AUC84d)
Timeframe: 85 days
Anti-erenumab antibodies
Timeframe: 85 days
Locations
Location
Research Site
Anaheim, CA, United States, 92801
Status
Completed
Location
Research Site
Leuven, Belgium, 3000
Status
Recruiting
Location
Research Site
Leiden, Netherlands, 2333 CL
Status
Recruiting