CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 35 enrolled
Drug / intervention
Erenumab +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02542605
NCT02542605Phase 1Completed
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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

Amgen·interventional·Posted Sep 7, 2015·Updated Jun 3, 2019

In Brief

A Phase 1 clinical trial evaluating Erenumab, Placebo, and 1 other intervention for Migraine. Completed, enrolled 35 participants across 3 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMigraine
CountriesBelgium, Netherlands, United States
Collaborators--

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 7, 2015
Enrollment StartNov 11, 2015
Primary CompletionSep 28, 2017
Study CompletionNov 8, 2017
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 10.8 years ago

Interventions

Erenumabdrug

Administered once on day 1 of Part B of the study by intravenous infusion.

Placebodrug

Administered once on day 1 of Part B of the study by intravenous infusion.

PACAP-38 Challenge Agentdrug

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.