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

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ClinicalTrials.gov Identifier: NCT02456740
Recruitment Status : Completed
First Posted : May 28, 2015
Results First Posted : July 10, 2018
Last Update Posted : October 9, 2019
Sponsor:
Information provided by (Responsible Party):
Amgen

Tracking Information
First Submitted Date  ICMJE May 14, 2015
First Posted Date  ICMJE May 28, 2015
Results First Submitted Date  ICMJE June 12, 2018
Results First Posted Date  ICMJE July 10, 2018
Last Update Posted Date October 9, 2019
Actual Study Start Date  ICMJE July 17, 2015
Actual Primary Completion Date September 5, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 13, 2018)
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 treatment phase ]
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 change from baseline in monthly migraine days was calculated as the average number of migraine days per month during the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatment phase - the number of migraine days during the 4-week baseline phase.
Original Primary Outcome Measures  ICMJE
 (submitted: May 26, 2015)
Change from baseline in mean monthly migraine days [ Time Frame: Completion of double blind treatment phase at 24 weeks. ]
To evaluate the effect of AMG 334 compared to placebo on the change from baseline in monthly migraine days, in subjects with episodic migraine
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 13, 2018)
  • 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 treatment phase ]
    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 with aura. At least a 50% reduction from baseline in monthly migraine days was determined if the change in monthly migraine days from the 4-week baseline phase to the last 3 months (mean of months 4, 5 and 6) of the 24-week double-blind treatment phase * 100 / baseline monthly migraine days was less than or equal to -50%.
  • 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 treatment phase ]
    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 migraine medications and ergotamine-based migraine medications. The change from baseline in monthly acute migraine-specific treatment days was calculated as the average number of migraine-specific treatment days per month during the last 3 months of the 24-week double-blind treatment phase - the number of migraine-specific treatment days during the 4-week baseline phase.
  • 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 treatment phase ]
    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 question. Participants completed the MPFID daily in an electronic diary based on the past 24 hours. Participants responded to each item on a 5-point scale, with difficulty items ranging from "Without any difficulty" (1) to "Unable to do" (5) and frequency items ranging from "None of the time" (1) to "All of the time" (5). For each domain, the scores were calculated as the sum of the responses and rescaled to 0 - 100, with higher scores representing greater impact of migraine. Change from baseline was calculated as (mean monthly average physical impairment scores as measured by the MPFID over the last 3 months of the double-blind treatment period) - (baseline monthly average physical impairment scores as measured by the MPFID).
  • 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 treatment phase ]
    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 question. Participants completed the MPFID daily in an electronic diary based on the past 24 hours. Participants responded to each item on a 5-point scale, with difficulty items ranging from "Without any difficulty" (1) to "Unable to do" (5) and frequency items ranging from "None of the time" (1) to "All of the time" (5). For each domain, the scores were calculated as the sum of the responses and rescaled to 0 - 100, with higher scores representing greater impact of migraine. Change from baseline was calculated as (mean monthly impact on everyday activities scores as measured by the MPFID over the last 3 months of the double-blind treatment period) - (baseline monthly impact on everyday activities scores as measured by the MPFID).
Original Secondary Outcome Measures  ICMJE
 (submitted: May 26, 2015)
  • 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. ]
    To evaluate the effect of AMG 334 compared to placebo on the change from baseline on the proportion of subjects with at least 50% reduction from baseline in monthly migraine days, in subjects with episodic migraine
  • Change from baseline in mean monthly acute migraine-specific medication treatment days. [ Time Frame: Completion of double blind treatment phase at 24 weeks. ]
    To evaluate the effect of AMG 334 compared to placebo on the change from baseline in monthly acute migraine-specific medication treatment days, in subjects with episodic migraine
  • Change from baseline in physical impairment. [ Time Frame: Completion of double blind treatment phase at 24 weeks. ]
    To evaluate the effect of AMG 334 compared to placebo on the change from baseline in physical impairment as assessed by migraine physical function impact diary, in subjects with episodic migraine.
  • Change from baseline on impact on everyday activities. [ Time Frame: Completion of double blind treatment phase at 24 weeks. ]
    To evaluate the effect of AMG 334 compared to placebo on the change from baseline on impact on everyday activities as assessed by migraine physical function impact diary, in subjects with episodic migraine
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in Migraine Prevention
Official Title  ICMJE A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AMG 334 in Migraine Prevention
Brief Summary 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.
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Migraine
Intervention  ICMJE
  • Drug: Erenumab
    Administered by subcutaneous injection once a month
    Other Names:
    • AMG 334
    • Aimovig™
  • Drug: Placebo
    Administered by subcutaneous injection once a month
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Placebo
  • 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.
    Intervention: Drug: Erenumab
  • 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.
    Intervention: Drug: Erenumab
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 26, 2016)
955
Original Estimated Enrollment  ICMJE
 (submitted: May 26, 2015)
852
Actual Study Completion Date  ICMJE June 19, 2017
Actual Primary Completion Date September 5, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Belgium,   Canada,   Czechia,   Finland,   Germany,   Netherlands,   Poland,   Slovakia,   Sweden,   Turkey,   United Kingdom,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02456740
Other Study ID Numbers  ICMJE 20120296
2014-004464-38 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amgen
Study Sponsor  ICMJE Amgen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP