Clinical Trial Summary : 20150308
Study to Evaluate the Efficacy and Safety of AMG 301 in Migraine Prevention FDA Regulated: Yes

This study has been completed.
Verified by Amgen, July 2019

Sponsored by: Amgen
Information provided by: Amgen

Delayed Results Posting
Delay Type: Certify Initial Approval
Intervention Name: AMG 301
FDA Application Numbers:
Requested Submission Date:  
Explanation:

Purpose

To evaluate the effect of AMG 301 compared to placebo on the change from the baseline period in monthly migraine days in subjects with migraine.


Condition Intervention Phase
Chronic Migraine or Episodic Migraine
Drug: Placebo
Drug: AMG 301
Drug: AMG 301
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
No Masking: false
Official Title: A Phase 2a Randomized Double-blind Placebo Controlled Study to Evaluate the Efficacy and Safety of AMG 301 in Migraine Prevention


Further study details as provided by Amgen

Primary Outcome Measures:
  • Change from the baseline period in monthly migraine days. The monthly migraine days will be calculated using the migraine days over the last 4 weeks of the 12-week double-blind treatment period. [ Time Frame: Last 4 weeks ]
    To evaluate the effect of AMG 301 compared to placebo on the change from the baseline period in monthly migraine days in subjects with migraine.

Secondary Outcome Measures:
  • At least a 50% reduction from the baseline period in monthly migraine days in the last 4 weeks of the 12-week double-blind treatment period [ Time Frame: Last 4 weeks ]
    To evaluate the effect of AMG 301 compared to placebo on the proportion of subject with at least 50% reduction from the baseline period in monthly migraine days

  • Change from the baseline period in monthly acute migraine-specific medication days in the last 4 weeks of the 12-week double-blind treatment period. [ Time Frame: Last 4 weeks ]
    To evaluate the effect of AMG 301 compared to placebo on the change from the baseline period in monthly acute migraine-specific medication treatment days.

  • Change from the baseline period in mean physical impairment domain scores as measured by the MPFID over the last 4 weeks of the 12-week double-blind treatment period. [ Time Frame: Last 4 weeks ]
    To evaluate the effect of AMG 301 compared to placebo on the change from the baseline period in monthly physical impairment domain score as measured by the Migraine Physical Function Impact Diary (MPFID).

  • Change from the baseline period in mean impact on everyday activities domain scores as measured by the MPFID over the last 4 weeks of the 12-week double-blind treatment period. [ Time Frame: Last 4 weeks ]
    To evaluate the effect of AMG 301 compared to placebo on the change from the baseline period in monthly impact on everyday activities domain score as measured by the MPFID.

Enrollment: 343
Study Start Date:2017 September DDDD Study Start Date Type: Actual

Study Completion Date: February 2019
Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Placebo Comparator: Placebo
AMG 301 Placebo Comparator
Drug: Placebo
Placebo Comparator
Experimental: AMG 301 High
High dose of AMG 301 Investigational Product
Drug: AMG 301
Investigational Product
Experimental: AMG 301 Low
Low dose of AMG 301 Investigational Product
Drug: AMG 301
Investigational Product

Detailed Description:
A Phase 2a, randomized, double-blind, placebo-controlled, 3-arm parallel group study to evaluate the efficacy and safety of AMG 301 in subjects with chronic migraine or episodic migraine.


Eligibility

Ages Eligible for Study:  18 Years  to 60 Years
Genders Eligible for Study:  Both
Gender Based:  No
Gender Eligibility Description: 
Accepts Healthy Volunteers:  No

Criteria

Inclusion Criteria:
• Adults ≥ 18 to ≤ 60 years of age at the time of signing the informed consent form.
• History of migraine (with or without aura) for ≥ 12 months before screening according to the International Headache Society (IHS) Classification ICHD-III (Headache Classification Committee of the International Headache Society, 2013)
• Migraine frequency: ≥ 4 migraine days per month on average across the 3 months before screening.
• Failed at least 1 medication for prophylactic treatment of migraine due to tolerability or lack of efficacy

Exclusion Criteria:
• Older than 50 years of age at migraine onset.
• History of cluster headache, hemiplegic migraine headache
• Unable to differentiate migraine from other headaches
• Migraine with continuous pain, in which the subject does not experience any
• free periods (of any duration) during the 1 month before the screening period
• History or evidence of any other clinically significant disorder, condition or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.


Contacts and Locations

Contacts
Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com

 Show 49 Study Locations

Sponsors and Collaborators
Amgen
Oversight
Is FDA Regulated Intervention: Yes
U.S. FDA IND/IDE Study: Yes
Section 801 Trial: Yes

Investigators
Study Director: MD   Amgen

More Information

http://www.amgentrials.com

No publications provided

Responsible Party:
Other Study ID Numbers: 20150308, 2017-000630-57
Health Authority:
U.S. FDA-regulated Drug Yes
U.S. FDA-regulated Device No
Post Prior to Approval/Clearance
Pediatric Postmarket Surveillance
Product Exported From U.S.

Keywords provided by Amgen:

Migraine
Headache
Prevention
Prophylaxis