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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Amgen
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT02066415
First received: February 17, 2014
Last updated: August 4, 2014
Last verified: August 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Change in monthly migraine attacks from baseline [ Time Frame: Completion of double-blind treatment phase at 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 490
Study Start Date: February 2014
Estimated Study Completion Date: August 2016
Estimated 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 490 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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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.
  • 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
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: NCT02066415

Contacts
Contact: Amgen Call Center 866-572-6436

  Show 47 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02066415     History of Changes
Other Study ID Numbers: 20120295
Study First Received: February 17, 2014
Last Updated: August 4, 2014
Health Authority: Denmark: Danish Health and Medicines Authority
Germany: Paul-Ehrlich-Institut
Finland: Finnish Medicines Agency
Norway: Norwegian Medicines Agency
Sweden: Medical Products Agency
United States: Food and Drug Administration
Canada: Health Canada
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

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

ClinicalTrials.gov processed this record on September 22, 2014