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

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ClinicalTrials.gov Identifier: NCT02456740
Recruitment Status : Completed
First Posted : May 28, 2015
Last Update Posted : June 23, 2017
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
Randomized, stratified, double-blind, placebo-controlled, parallel-group, multi-center study followed by active-treatment phase. To evaluate the effect of AMG 334 compared to placebo on the change from baseline in monthly migraine days.

Condition or disease Intervention/treatment Phase
Migraine Drug: AMG 334 Drug: Placebo Phase 3

Detailed Description:
Randomized, stratified, double-blind, placebo-controlled, parallel-group, multi-center study followed by active-treatment phase. Adults with one-year history of episodic migraine and currently, previously or never received migraine prophylactic medication will be randomized to one of two AMG 334 treatment groups or a placebo treatment group during the double blind treatment phase. During the active treatment phase, subjects will be randomized to one of the two AMG 334 treatment groups.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 955 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Actual Study Start Date : July 17, 2015
Actual Primary Completion Date : September 5, 2016
Actual Study Completion Date : June 19, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
Experimental: AMG 334 Dose level 1
Low dose of Active AMG 334 Investigational Product
Drug: AMG 334
Investigational Product

Experimental: AMG 334 Dose level 2
High dose of Active AMG 334 Investigational Product
Drug: AMG 334
Investigational Product

Placebo Comparator: Placebo
AMG 334 Placebo Comparator
Drug: Placebo
Placebo Comparator




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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 proportion of subjects with at least 50% reduction from baseline in monthly migraine days

  2. 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

  3. 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 change from baseline in mean physical impairment domain score as measured by the Migraine Physical Function Impact Diary (MPFID)

  4. 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 change from baseline in mean impact on everyday activities domain score as measured by the MPFID



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:-History of migraine (with or without aura) for ≥ 12 months prior to screening according to the IHS Classification ICHD-3 (Headache Classification Committee of the International Headache Society, 2013)

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02456740


  Show 129 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02456740     History of Changes
Other Study ID Numbers: 20120296
2014-004464-38 ( EudraCT Number )
First Posted: May 28, 2015    Key Record Dates
Last Update Posted: June 23, 2017
Last Verified: June 2017

Keywords provided by Amgen:
Migraine
Headache
Prevention
Prophylaxis

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases