A Safety and Efficacy Study to Evaluate AMG 334 in Migraine Prevention

NCT02630459 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 475

Last updated 2022-10-12

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Summary

Randomized, double-blind, placebo-controlled, parallel-group, multicenter study followed by an open-label treatment phase (OLTP). To evaluate the effect of erenumab (AMG 334) compared to placebo on the change from baseline in monthly migraine days.

Conditions

Interventions

DRUG

Placebo

placebo via subcutaneous injection

DRUG

Erenumab

erenumab via subcutaneous injection

DRUG

Erenumab

erenumab via autoinjector (AI)/pen

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-06
Primary Completion
2017-09-25
Completion
2019-06-05
FDA Drug
Yes

Countries

  • Japan

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02630459 on ClinicalTrials.gov