Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study to Evaluate the Efficacy and Safety of AMG 301 in Migraine Prevention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03238781
Recruitment Status : Completed
First Posted : August 3, 2017
Last Update Posted : February 6, 2019
Sponsor:
Information provided by (Responsible Party):
Amgen

Tracking Information
First Submitted Date  ICMJE August 1, 2017
First Posted Date  ICMJE August 3, 2017
Last Update Posted Date February 6, 2019
Actual Study Start Date  ICMJE September 6, 2017
Actual Primary Completion Date October 16, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 1, 2017)
Change from the baseline period in monthly migraine days. The monthly migraine days will be calculated using the migraine days over the last 4 weeks of the 12-week double-blind treatment period. [ Time Frame: Last 4 weeks ]
To evaluate the effect of AMG 301 compared to placebo on the change from the baseline period in monthly migraine days in subjects with migraine.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03238781 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 1, 2017)
  • At least a 50% reduction from the baseline period in monthly migraine days in the last 4 weeks of the 12-week double-blind treatment period [ Time Frame: Last 4 weeks ]
    To evaluate the effect of AMG 301 compared to placebo on the proportion of subject with at least 50% reduction from the baseline period in monthly migraine days
  • Change from the baseline period in monthly acute migraine-specific medication days in the last 4 weeks of the 12-week double-blind treatment period. [ Time Frame: Last 4 weeks ]
    To evaluate the effect of AMG 301 compared to placebo on the change from the baseline period in monthly acute migraine-specific medication treatment days.
  • Change from the baseline period in mean physical impairment domain scores as measured by the MPFID over the last 4 weeks of the 12-week double-blind treatment period. [ Time Frame: Last 4 weeks ]
    To evaluate the effect of AMG 301 compared to placebo on the change from the baseline period in monthly physical impairment domain score as measured by the Migraine Physical Function Impact Diary (MPFID).
  • Change from the baseline period in mean impact on everyday activities domain scores as measured by the MPFID over the last 4 weeks of the 12-week double-blind treatment period. [ Time Frame: Last 4 weeks ]
    To evaluate the effect of AMG 301 compared to placebo on the change from the baseline period in monthly impact on everyday activities domain score as measured by the MPFID.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Efficacy and Safety of AMG 301 in Migraine Prevention
Official Title  ICMJE A Phase 2a Randomized Double-blind Placebo Controlled Study to Evaluate the Efficacy and Safety of AMG 301 in Migraine Prevention
Brief Summary To evaluate the effect of AMG 301 compared to placebo on the change from the baseline period in monthly migraine days in subjects with migraine.
Detailed Description A Phase 2a, randomized, double-blind, placebo-controlled, 3-arm parallel group study to evaluate the efficacy and safety of AMG 301 in subjects with chronic migraine or episodic migraine.
Study Type  ICMJE Interventional
Study Phase Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Chronic Migraine or Episodic Migraine
Intervention  ICMJE
  • Drug: Placebo
    Placebo Comparator
  • Drug: AMG 301
    Investigational Product
Study Arms
  • Placebo Comparator: Placebo
    AMG 301 Placebo Comparator
    Intervention: Drug: Placebo
  • Experimental: AMG 301 High
    High dose of AMG 301 Investigational Product
    Intervention: Drug: AMG 301
  • Experimental: AMG 301 Low
    Low dose of AMG 301 Investigational Product
    Intervention: Drug: AMG 301
Publications * Not Provided

*   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: August 9, 2018)
343
Original Estimated Enrollment  ICMJE
 (submitted: August 1, 2017)
335
Actual Study Completion Date February 4, 2019
Actual Primary Completion Date October 16, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adults ≥ 18 to ≤ 60 years of age at the time of signing the informed consent form.
  • History of migraine (with or without aura) for ≥ 12 months before screening according to the International Headache Society (IHS) Classification ICHD-III (Headache Classification Committee of the International Headache Society, 2013)
  • Migraine frequency: ≥ 4 migraine days per month on average across the 3 months before screening.
  • Failed at least 1 medication for prophylactic treatment of migraine due to tolerability or lack of efficacy

Exclusion Criteria:

  • Older than 50 years of age at migraine onset.
  • History of cluster headache, hemiplegic migraine headache
  • Unable to differentiate migraine from other headaches
  • Migraine with continuous pain, in which the subject does not experience any pain-free periods (of any duration) during the 1 month before the screening period
  • History or evidence of any other clinically significant disorder, condition or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Canada,   Czechia,   Denmark,   Finland,   Germany,   Sweden,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03238781
Other Study ID Numbers  ICMJE 20150308
2017-000630-57 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
URL: https://www.amgen.com/datasharing
Responsible Party Amgen
Study Sponsor  ICMJE Amgen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date February 2019

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