Overview

This trial is active, not recruiting.

Condition migraine
Treatments amg 334, placebo
Phase phase 2
Sponsor Amgen
Start date August 2013
End date September 2014
Trial size 483 participants
Trial identifier NCT01952574, 20120178

Summary

Randomized, double-blind, placebo-controlled, parallel-group, multi-center study followed by open-label 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 safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
Lowest dose of Active AMG 334 Investigational Product
amg 334
Investigational Product
(Experimental)
Middle dose of Active AMG 334 Investigational Product
amg 334
Investigational Product
(Experimental)
Highest dose of Active AMG 334 Investigational Product
amg 334
Investigational Product
(Placebo Comparator)
AMG 334 Placebo Comparator
placebo
Placebo Comparator

Primary Outcomes

Measure
Change in monthly migraine days from baseline in the last 4 weeks of the 12-week double-blind treatment phase
time frame: Completion of double-blind treatment phase at 12 weeks

Secondary Outcomes

Measure
Proportion of subjects with at least a 50% reduction from baseline in monthly migraine days in the last 4 weeks of the 12-week double-blind treatment phase
time frame: Completion of double-blind treatment phase at 12 weeks
Change in monthly migraine attacks from baseline in the last 4 weeks of the 12-week double-blind treatment phase
time frame: Completion of double-blind treatment phase at 12 weeks
Adverse events, clinical laboratory values, electrocardiogram, vital signs, anti-AMG 334 antibodies
time frame: Completion of double-blind treatment phase at 12 weeks and open-label treatment phase and safety follow-up at end of study

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

Inclusion Criteria: - History of migraine for more than12 months prior to screening - Migraine frequency: ≥ 4 and ≤ 14 migraine days per month in each of the 3 months prior to screening and during baseline phase - Headache frequency: < 15 headache days per month (with > 50% of the headache days being migraine days) in each of the 3 months prior to screening and during baseline phase - Demonstrated at least 80% compliance with the eDiary during baseline phase Exclusion Criteria: - Older than 50 years of age at migraine onset - History of cluster headache or basilar or hemiplegic migraine headache - Unable to differentiate migraine from other headaches - Failed > 2 medication categories due to lack of efficacy for prophylactic treatment of migraine after an adequate therapeutic trial - Used a prohibited migraine prophylactic medication, device or procedure within 2 months prior to the start of the baseline phase - Overuse of acute migraine medications in any month during the 3 months prior to screening or during screening

Additional Information

Official title A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AMG 334 in Migraine Prevention
Description Randomized, double-blind, placebo-controlled, parallel-group, multi-center study followed by open-label phase. Adults with a one-year history of episodic migraine and not receiving migraine prophylaxis medication will be randomized to one of three AMG 334 treatment groups or a placebo treatment group.
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Amgen.