A Phase 2 Study to Evaluate the Efficacy and Safety of AMG 334 in Migraine Prevention

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01952574
First received: August 30, 2013
Last updated: July 11, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention Phase
Migraine
Drug: AMG 334
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AMG 334 in Migraine Prevention

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    To evaluate the effect of AMG 334 compared to placebo on the change from baseline in monthly migraine days, in subjects with episodic migraine


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    To evaluate the effect of AMG 334 compared to placebo on the proportion of subjects with at least 50% reduction from baseline in monthly migraine days

  • 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 ] [ Designated as safety issue: No ]
    To evaluate the effect of AMG 334 compared to placebo as measured by reduction from baseline in monthly migraine attacks

  • 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 ] [ Designated as safety issue: Yes ]
    To evaluate the safety and tolerability of AMG 334


Enrollment: 483
Study Start Date: August 2013
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AMG 334 Dose Level 1
Lowest dose of Active AMG 334 Investigational Product
Drug: AMG 334
Investigational Product
Experimental: AMG 334 Dose Level 2
Middle dose of Active AMG 334 Investigational Product
Drug: AMG 334
Investigational Product
Experimental: AMG 334 Dose Level 3
Highest dose of Active AMG 334 Investigational Product
Drug: AMG 334
Investigational Product
Placebo Comparator: Placebo
AMG 334 Placebo Comparator
Drug: Placebo
Placebo Comparator

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01952574

  Show 66 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01952574     History of Changes
Other Study ID Numbers: 20120178
Study First Received: August 30, 2013
Last Updated: July 11, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Denmark: Danish Health and Medicines Authority
Finland: Finnish Medicines Agency
Germany: Paul-Ehrlich-Institut Federal Institute for Vaccines and BiomedicinesNorway: Norwegian Medicines Agency
Sweden: Medical Products Agency

Keywords provided by Amgen:
migraine, headache, prevention, prophylaxis

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 18, 2014