NCT02542605

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	Erenumab	Administered once on day 1 of Part B of the study by intravenous infusion.
DRUG	Placebo	Administered once on day 1 of Part B of the study by intravenous infusion.
DRUG	PACAP-38 Challenge Agent	Administered by intravenous infusion during Part A of the study for dose selection for Part B. Administered by intravenous infusion on day 8 in Part B as a challenge agent to induce a migraine-like attack.

Timeline

• Start date: 2015-11-11
• Primary completion: 2017-09-28
• Completion: 2017-11-08
• First posted: 2015-09-07
• Last updated: 2019-06-03
• Results posted: 2019-06-03

Locations

3 sites across 3 countries: United States, Belgium, Netherlands