Simi Valley, California 93065

  • Migraine

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.


Study summary:

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).


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


Study is Available At:


Original ID:

20120296


NCT ID:

NCT02456740


Secondary ID:

2014-004464-38


Study Acronym:

STRIVE


Brief Title:

Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in Migraine Prevention


Official Title:

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AMG 334 in Migraine Prevention


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Amgen


Oversight Authority:

  • United States: Food and Drug Administration
  • Canada: Health Canada
  • Finland: Finnish Medicines Agency
  • Germany: The Federal Institute for Drugs and Medical Devices
  • United Kingdom: Medicines and Healthcare Products Regulatory Agency
  • 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)


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

955


Enrollment Type:

Actual


Overall Contact Information

Official Name:MD
Study Director
Amgen

Study Dates

Start Date:July 17, 2015
Completion Date:June 19, 2017
Completion Type:Actual
Primary Completion Date:September 5, 2016
Primary Completion Type:Actual
Verification Date:September 2019
Last Changed Date:September 26, 2019
First Received Date:May 14, 2015
First Results Date:June 12, 2018

Study Outcomes

Outcome Type:Primary Outcome
Measure:Change From Baseline in Mean Monthly Migraine Days to the Last 3 Months of the Double-blind Treatment Period
Time Frame:4-week baseline phase and the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatme
Safety Issues:False
Description:A migraine day was any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined either as a migraine with or without aura. The
Outcome Type:Secondary Outcome
Measure:Percentage of Participants With at Least a 50% Reduction From Baseline in Monthly Migraine Days in the Last 3 Months of the Double-blind Treatment Phase
Time Frame:4-week baseline phase and the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatme
Safety Issues:False
Description:A migraine day was any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined either as a migraine without aura or a migraine
Outcome Type:Secondary Outcome
Measure:Change From Baseline in Monthly Acute Migraine-specific Medication Treatment Days to the Last 3 Months of the Double-blind Treatment Period
Time Frame:4-week baseline phase and the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatme
Safety Issues:False
Description:Monthly acute migraine-specific medication treatment days is the number of days on which migraine specific medications were used between monthly doses of study drug. Migraine-specific medications includes two categories of medications: triptan-based migra
Outcome Type:Secondary Outcome
Measure:Change From Baseline in Mean Monthly Average Physical Impairment Domain Score Measured by MPFID in the Last 3 Months of the Double-blind Treatment Phase
Time Frame:4-week baseline phase and the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatme
Safety Issues:False
Description:The Migraine Physical Function Impact Diary (MPFID) is a self-administered 13-item instrument measuring physical functioning. It has two domains, Impact on Everyday Activities (7 items) and Physical Impairment (5 items), and one stand-alone global questio
Outcome Type:Secondary Outcome
Measure:Change From Baseline in Mean Monthly Average Impact on Everyday Activities Score Measured by MPFID in the Last 3 Months of the Double-blind Treatment Phase
Time Frame:4-week baseline phase and the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatme
Safety Issues:False
Description:The Migraine Physical Function Impact Diary (MPFID) is a self-administered 13-item instrument measuring physical functioning. It has two domains, Impact on Everyday Activities (7 items) and Physical Impairment (5 items), and one stand-alone global questio

Study Interventions

Intervention Type:Drug
Name:Erenumab
Description:Administered by subcutaneous injection once a month
Arm Name:Erenumab 70 mg QM
Other Name:AMG 334
Intervention Type:Drug
Name:Placebo
Description:Administered by subcutaneous injection once a month
Arm Name:Placebo

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:Placebo
Description: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.
Study Arm Type:Experimental
Arm Name:Erenumab 70 mg QM
Description: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.
Study Arm Type:Experimental
Arm Name:Erenumab 140 mg QM
Description: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.

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Amgen

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Buse DC, Lipton RB, Hallström Y, Reuter U, Tepper SJ, Zhang F, Sapra S, Picard H, Mikol DD, Lenz RA. Migraine-related disability, impact, and health-related quality of life among patients with episodic migraine receiving preventive treatment with erenumab. Cephalalgia. 2018 Sep;38(10):1622-1631. doi: 10.1177/0333102418789072. Epub 2018 Aug 7.
PMID:30086681
Reference Type:Reference
Citation:Goadsby PJ, Reuter U, Hallström Y, Broessner G, Bonner JH, Zhang F, Sapra S, Picard H, Mikol DD, Lenz RA. A Controlled Trial of Erenumab for Episodic Migraine. N Engl J Med. 2017 Nov 30;377(22):2123-2132. doi: 10.1056/NEJMoa1705848.
PMID:29171821
Reference Type:Reference
Citation:Sunfa Cheng, Herman Picard, Feng Zhang, Osa Eisele, Daniel Mikol. Efficacy and safety of erenumab for migraine prevention: an overview. Japanese Journal of Headache 45(3): 493-505, 2019.

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.