Clinical Trial Summary : 20120296
Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in Migraine Prevention  (STRIVE) FDA Regulated: Yes

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

Sponsored by: Amgen
Information provided by: Amgen

Purpose

The primary objective of the study was to evaluate the effect of erenumab compared to placebo on the change from baseline in monthly migraine days.


Condition Intervention Phase
Migraine
Drug: Erenumab
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind   (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AMG 334 in Migraine Prevention


Further study details as provided by Amgen

Primary Outcome Measures:
  • Change from baseline in mean monthly migraine days [ Time Frame: Completion of double blind treatment phase at 24 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 50% reduction from baseline in monthly migraine days [ Time Frame: Completion of double blind treatment phase at 24 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 from baseline in mean monthly acute migraine-specific medication treatment days. [ Time Frame: Completion of double blind treatment phase at 24 weeks ] [ Designated as safety issue: No ]
    To evaluate the effect of AMG 334 compared to placebo on the change from baseline in monthly acute migraine-specific medication treatment days

  • Change from baseline in physical impairment. [ Time Frame: Completion of double blind treatment phase at 24 weeks ] [ Designated as safety issue: No ]
    To evaluate the effect of AMG 334 compared to placebo on change from baseline in mean physical impairment domain score as measured by the Migraine Physical Function Impact Diary (MPFID)

  • Change from baseline on impact on everyday activities. [ Time Frame: Completion of double blind treatment phase at 24 weeks ] [ Designated as safety issue: No ]
    To evaluate the effect of AMG 334 compared to placebo on change from baseline in mean impact on everyday activities domain score as measured by the MPFID

Enrollment: 955
Study Start Date:2015 July DDDD Study Start Date Type: Actual

Study Completion Date: June 2017
Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Placebo Comparator: Placebo
Participants received placebo once a month (QM) by subcutaneous injection on day 1 and weeks 4, 8, 12, 16,
and 20 in the 24-week double-blind treatment phase. At week 24, participants were re-randomized to receive either erenumab 70 mg or erenumab 140 mg, administered QM at weeks 24, 28, 32, 36, 40, 44, and 48, with actual dose blinded.
Drug: Placebo
Administered by subcutaneous injection once a month
Experimental: Erenumab 70 mg QM
Participants received erenumab 70 mg QM by subcutaneous injection on day 1 and weeks 4, 8, 12, 16, and 20 in the 24-week double-blind treatment phase. At week 24, participants were re-randomized to receive either erenumab 70 mg or erenumab 140 mg, administered QM at weeks 24, 28, 32, 36, 40, 44, and 48, with actual dose blinded.
Drug: Erenumab
Administered by subcutaneous injection once a month
Other Name: AMG 334
Other Name: Aimovig™
Experimental: Erenumab 140 mg QM
Participants received erenumab 140 mg QM by subcutaneous injection on day 1 and weeks 4, 8, 12, 16, and 20 in the 24-week double-blind treatment phase. At week 24, participants were re-randomized to receive either erenumab 70 mg or erenumab 140 mg, administered QM at weeks 24, 28, 32, 36, 40, 44, and 48, with actual dose blinded.
Drug: Erenumab
Administered by subcutaneous injection once a month
Other Name: AMG 334
Other Name: Aimovig™

Detailed Description:
This was a multicenter, randomized, double-blind,
placebo-controlled, parallel-group trial. The trial consisted of four phases: screening (≤ 3 weeks of initial screening and a 4-week baseline phase); the double-blind treatment phase (24 weeks) in which participants received placebo or erenumab 70 mg or 140 mg daily; the active-treatment phase, in which participants underwent repeat randomization and were assigned to receive 70 mg or 140 mg of erenumab (28 weeks); and a safety follow-up phase (12 weeks).


Eligibility

Ages Eligible for Study:  18 Years  to 65 Years
Genders Eligible for Study:  Both
Gender Based: 
Gender Eligibility Description: 
Accepts Healthy Volunteers:  No

Criteria

Inclusion Criteria:
• History of migraine (with or without aura) for ≥ 12 months prior to screening according to the International Headache Society (IHS) International Classification of Headache Disorders (ICHD-3) classification
• Migraine frequency: ≥ 4 and < 15 migraine days per month on average across the 3 months prior to screening and during baseline
• Headache frequency: < 15 headache days per month on average across the 3 months prior to screening and baseline
• Demonstrated at least 80% compliance with the eDiary.

Exclusion Criteria:
• Older than 50 years of age at migraine onset
• History of cluster headache or hemiplegic migraine headache
• Unable to differentiate migraine from other headache
• No therapeutic response with > 2 medication categories for prophylactic treatment of migraine after an adequate therapeutic trial
• Used a prohibited medication, device, or procedure within 2 months prior to the start of the baseline phase or during the baseline phase
• Concomitant use of 2 or more medications with possible migraine prophylactic effects within 2 months prior to the start of the baseline phase or during the baseline phase. If only 1 prophylactic medication is used, the dose must be stable within 2 months prior to the start of the baseline phase and throughout the study


Contacts and Locations

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

 Show 132 Study Locations

Sponsors and Collaborators
Amgen
Oversight
Is FDA Regulated Intervention: Yes
U.S. FDA IND/IDE Study: Yes
Section 801 Trial: Yes
Unapproved/Uncleared Device: No

Investigators
Study Director: MD   Amgen

More Information
Responsible Party: Global Development Leader, Amgen Inc.
Other Study ID Numbers: 20120296, 2014-004464-38
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Finland: Finnish Medicines Agency
Germany: The Federal Institute for Drugs and Medical Devices
UK: Medicines and Healthcare Products Regulatory Agency (MHRA
Belgium: FAMHP - Federal Agency for Medicines and Health Products
Sweden: Medical Products Agency
Poland: The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Czech Republic: Statni ustav pro kontrolu leciv
Slovakia: State Institute For Drug Control
Austria: Bundesamt für Sicherheit im Gesundheitswesen (BASG)
Turkey: Turkish Medicines and Medical Devices Agency
Netherlands: Warenwet (NVWA)
U.S. FDA-regulated Drug
U.S. FDA-regulated Device
Post Prior to Approval/Clearance
Pediatric Postmarket Surveillance
Product Exported From U.S.

Keywords provided by Amgen:

Migraine
Headache
Prevention
Prophylaxis