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Study to Evaluate the Efficacy and Safety of AMG 334 Compared to Placebo in Migraine Prevention (ARISE)

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ClinicalTrials.gov Identifier: NCT02483585
Recruitment Status : Completed
First Posted : June 29, 2015
Last Update Posted : June 6, 2017
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
A Phase 3, Randomized, Double-blind, Placebo-controlled Study followed by open-label treatment phase. To evaluate the effect of AMG 334 compared to placebo on the change from baseline in monthly migraine days, in subjects with episodic migraine

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

Detailed Description:
A Phase 3, Randomized, Double-blind, Placebo-controlled Study followed by open-label treatment phase. Adults with a history of migraine with or without aura for ≥ 12 months and who experience ≥ 4 to < 15 migraine days per month with < 15 headache days per month will be randomized 1:1 to placebo or AMG 334. Double-blind AMG 334 or placebo will be administered during the 12-week double-blind treatment phase and open-label AMG 334 will be administered during the 28-week open-label treatment phase. Investigational product doses are fixed and will not be adjusted for individual subjects during the study.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 577 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 20, 2015
Actual Primary Completion Date : July 11, 2016
Actual Study Completion Date : March 20, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
Experimental: AMG 334
AMG 334 or placebo will be administered during the 12-week double-blind treatment phase and open-label AMG 334 will be administered during the 28-week open-label treatment phase.
Drug: AMG 334
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 the double-blind treatment phase at month 3. ]
    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 a 50% reduction from baseline in monthly migraine days [ Time Frame: Completion of the double-blind treatment phase at month 3 ]
    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 monthly acute migraine-specific medication treatment days [ Time Frame: Completion of the double-blind treatment phase at month 3 ]
    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 the double-blind treatment phase at month 3 ]
    To evaluate the effect of AMG 334 compared to placebo on the proportion of subjects with at least a 5-point reduction from baseline in mean physical impairment domain score as measured by the MPFID

  4. Change from baseline in impact on everyday activities [ Time Frame: Completion of the double-blind treatment phase at month 3 ]
    To evaluate the effect of AMG 334 compared to placebo on the proportion of subjects with at least a 5-point reduction from baseline in mean impact on everyday activities domain score as measured by the Migraine Physical Function Impact Diary (MPFID)



Information from the National Library of Medicine

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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 Migraines
  • High migraine frequency
  • Demonstrated 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 headaches
  • No therapeutic response with > 2 categories for prophylactic treatment of migraine after an adequate therapeutic trial.
  • 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
  • Used a prohibited medication, device, or procedure within 2 months prior to the start of the baseline phase or during the baseline phase.
  • Received botulinum toxin
  • Anticipated to require any excluded medication, device, or procedure during the study.
  • Active chronic pain syndromes (such as fibromyalgia and chronic pelvic pain).
  • History of major psychiatric disorder.
  • History of seizure disorder or other significant neurological conditions other than migraine.
  • Human immunodeficiency virus (HIV) infection by history.
  • Myocardial infarction (MI), stroke, transient ischemic attack (TIA), unstable angina, or coronary artery bypass surgery or other revascularization procedure within 12 months prior to screening.
  • The subject is at risk of self-harm or harm to others. Previously randomized into an AMG 334 study.
  • Unlikely to be able to complete all protocol required study visits or procedures, and/or to comply with all required study procedures.

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): NCT02483585


  Show 76 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: NCT02483585     History of Changes
Other Study ID Numbers: 20120297
2014-004463-20 ( EudraCT Number )
First Posted: June 29, 2015    Key Record Dates
Last Update Posted: June 6, 2017
Last Verified: May 2017

Keywords provided by Amgen:
Migraine
Headache
Episodic
Prevention
Prophylaxis

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