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

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ClinicalTrials.gov Identifier: NCT03238781
Recruitment Status : Active, not recruiting
First Posted : August 3, 2017
Last Update Posted : October 22, 2018
Sponsor:
Information provided by (Responsible Party):
Amgen

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.

Condition or disease Intervention/treatment Phase
Chronic Migraine or Episodic Migraine Drug: Placebo Drug: AMG 301 Phase 2

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 : Interventional  (Clinical Trial)
Actual Enrollment : 343 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 2a Randomized Double-blind Placebo Controlled Study to Evaluate the Efficacy and Safety of AMG 301 in Migraine Prevention
Actual Study Start Date : September 6, 2017
Actual Primary Completion Date : October 16, 2018
Estimated Study Completion Date : February 4, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
Placebo Comparator: Placebo
AMG 301 Placebo Comparator
Drug: Placebo
Placebo Comparator

Experimental: AMG 301 High
High dose of AMG 301 Investigational Product
Drug: AMG 301
Investigational Product

Experimental: AMG 301 Low
Low dose of AMG 301 Investigational Product
Drug: AMG 301
Investigational Product




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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).

  4. 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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT03238781


  Show 49 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT03238781     History of Changes
Other Study ID Numbers: 20150308
2017-000630-57 ( EudraCT Number )
First Posted: August 3, 2017    Key Record Dates
Last Update Posted: October 22, 2018
Last Verified: October 2018
Individual Participant Data (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
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
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

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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