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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02066415
First Posted: February 19, 2014
Last Update Posted: September 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Amgen
  Purpose
To evaluate the effect of AMG 334 compared to placebo on the change from baseline in monthly migraine days

Condition Intervention Phase
Treatment for Prevention of Chronic Migraine Drug: AMG 334 Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study of Patients With Chronic Migraine.

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 ]

Secondary Outcome Measures:
  • Proportion of subjects with at least a 50% reduction from baseline in monthly migraine days [ Time Frame: Completion of double-blind treatment phase at 12 weeks ]
  • Change in monthly acute migraine-specific medication treatment days [ Time Frame: Completion of double-blind treatment phase at 12 weeks ]
  • Change in monthly cumulative hours of headache [ Time Frame: Completion of double-blind treatment phase at 12 weeks ]

Enrollment: 667
Study Start Date: March 2014
Study Completion Date: April 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AMG 334 Dose Level 1
AMG 334 Dose Level 1 (SC)
Drug: AMG 334
Investigational Product
Experimental: AMG 334 Dose Level 2
AMG 334 Dose Level 2 (SC)
Drug: AMG 334
Investigational Product
Placebo Comparator: Placebo
Placebo -(SC)
Drug: AMG 334
Investigational Product
Drug: Placebo
Placebo Comparator

Detailed Description:
Phase 2, multicenter, randomized, double-blind, placebo-controlled study of patients with chronic migraine. Approximately 651 subjects will be randomized to receive either placebo, or one of two AMG 334 subcutaneous (SC) doses every month for the duration of the 12-week double-blind treatment phase. There will also be safety follow-up visit after the treatment phase.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • History of at least 5 attacks of migraine without aura and/or migraine with visual sensory, speech and/or language, retinal or brainstem aura.
  • History of ≥ 15 headache days per month of which ≥ 8 headache days were assessed by the subject as migraine day.
  • ≥ 4 distinct headache episodes, each lasting ≥ 4 hours OR if shorter, associated with use of a triptan or ergot-derivative on the same calendar day based on the eDiary calculations.
  • Demonstrated at least 80% compliance with the eDiary.

Exclusion Criteria:

  • History of cluster headache or hemiplegic migraine headache
  • Unable to differentiate migraine from other headaches
  • Failed > 3 medication categories due to lack of efficacy for prophylactic treatment of migraine .
  • Received botulinum toxinin head or neck region within 4 months prior to screening.
  • Used a prohibited migraine prophylactic medication, device or procedure within 2 months prior to the start of the baseline phase
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02066415


  Show 74 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02066415     History of Changes
Other Study ID Numbers: 20120295
First Submitted: February 17, 2014
First Posted: February 19, 2014
Last Update Posted: September 27, 2016
Last Verified: September 2016

Keywords provided by Amgen:
Chronic Migraine

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