Overview

This trial is active, not recruiting.

Condition migraine
Treatments amg 334, placebo
Phase phase 3
Sponsor Amgen
Start date July 2015
End date September 2016
Trial size 955 participants
Trial identifier NCT02456740, 20120296, 2014-004464-38

Summary

Randomized, stratified, double-blind, placebo-controlled, parallel-group, multi-center study followed by active-treatment phase. To evaluate the effect of AMG 334 compared to placebo on the change from baseline in monthly migraine days.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Low dose of Active AMG 334 Investigational Product
amg 334
Investigational Product
(Experimental)
High dose of Active AMG 334 Investigational Product
amg 334
Investigational Product
(Placebo Comparator)
AMG 334 Placebo Comparator
placebo
Placebo Comparator

Primary Outcomes

Measure
Change from baseline in mean monthly migraine days
time frame: Completion of double blind treatment phase at 24 weeks.

Secondary Outcomes

Measure
Proportion of subjects with at least 50% reduction from baseline in monthly migraine days
time frame: Completion of double blind treatment phase at 24 weeks
Change from baseline in mean monthly acute migraine-specific medication treatment days.
time frame: Completion of double blind treatment phase at 24 weeks
Change from baseline in physical impairment.
time frame: Completion of double blind treatment phase at 24 weeks
Change from baseline on impact on everyday activities.
time frame: Completion of double blind treatment phase at 24 weeks

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria:-History of migraine (with or without aura) for ≥ 12 months prior to screening according to the IHS Classification ICHD-3 (Headache Classification Committee of the International Headache Society, 2013) - Migraine frequency: ≥ 4 and < 15 migraine days per month on average across the 3 months prior to screening and during baseline - Headache frequency: < 15 headache days per month on average across the 3 months prior to screening and baseline - Demonstrated at least 80% compliance with the eDiary. Exclusion Criteria: - Older than 50 years of age at migraine onset - History of cluster headache or hemiplegic migraine headache - Unable to differentiate migraine from other headache - No therapeutic response with > 2 medication categories for prophylactic treatment of migraine after an adequate therapeutic trial - Used a prohibited medication, device, or procedure within 2 months prior to the start of the baseline phase or during the baseline phase - Concomitant use of 2 or more medications with possible migraine prophylactic effects within 2 months prior to the start of the baseline phase or during the baseline phase. If only 1 prophylactic medication is used, the dose must be stable within 2 months prior to the start of the baseline phase and throughout the study

Additional Information

Official title A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AMG 334 in Migraine Prevention
Description Randomized, stratified, double-blind, placebo-controlled, parallel-group, multi-center study followed by active-treatment phase. Adults with one-year history of episodic migraine and currently, previously or never received migraine prophylactic medication will be randomized to one of two AMG 334 treatment groups or a placebo treatment group during the double blind treatment phase. During the active treatment phase, subjects will be randomized to one of the two AMG 334 treatment groups.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Amgen.