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A Controlled Trial of Erenumab in Migraine Prevention

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ClinicalTrials.gov Identifier: NCT03812224
Recruitment Status : Not yet recruiting
First Posted : January 23, 2019
Last Update Posted : February 7, 2019
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
Study is a phase 3 trial intended to assess the efficacy and safety of erenumab for prevention of migraine in Japanese subjects with episodic migraine (EM) and chronic migraine (CM).

Condition or disease Intervention/treatment Phase
Migraine Drug: Erenumab Phase 3

Detailed Description:
Migraine prevention is an area of a large unmet medical need, with existing therapies often having modest efficacy and poor tolerability. Calcitonin gene-related peptide (CGRP) receptor antagonism is a novel approach to migraine preventive therapy. Erenumab is a human monoclonal antibody against canonical CGRP receptor. The present study is a phase 3 trial intended to assess the efficacy and safety of erenumab for prevention of migraine in Japanese subjects with episodic migraine (EM) and chronic migraine (CM).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 256 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3 Japanese Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Erenumab in Migraine Prevention
Estimated Study Start Date : April 18, 2019
Estimated Primary Completion Date : September 22, 2020
Estimated Study Completion Date : April 6, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
Active Comparator: Erenumab
Dose 1 erenumab
Drug: Erenumab
Dose 1 erenumab or placebo will be dosed every 4 weeks, subcutaneously during the 24-week double blind treatment period.
Other Name: AMG 334

Drug: Erenumab
Dose 1 erenumab will be dosed every 4 weeks, subcutaneously during the 28-week open label treatment period.
Other Name: AMG 334

Placebo Comparator: Placebo
Placebo
Drug: Erenumab
Dose 1 erenumab or placebo will be dosed every 4 weeks, subcutaneously during the 24-week double blind treatment period.
Other Name: AMG 334




Primary Outcome Measures :
  1. Mean Monthly Migraine Days [ Time Frame: 67 weeks ]
    Change from baseline in mean Monthly Migraine Days over months 4, 5, and 6 of the double-blind treatment period (DBTP).


Secondary Outcome Measures :
  1. 50% reduction in MMD [ Time Frame: 67 weeks ]
    Achievement of at least a 50% reduction from baseline in mean MMD over months 4, 5, and 6 of the DBTP.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has provided informed consent/assent prior to initiation of any study specific activities/procedures.
  • Japanese subjects greater than or equal to 20 to less than or equal to 65 years of age upon entry into screening.
  • History of migraine (with or without aura) for greater than or equal to 12 months before screening according to the International Headache Society Classification ICHD-3 (Headache Classification Committee of the International Headache Society, 2018) based on medical records and/or patient self-report
  • Migraine frequency: Chronic Migraine (CM) or Episodic Migraine (EM) over the 3 months before screening (refer to Section 5.6 for definition of migraine day) based on the following criteria:

    1. CM is defined as greater than or equal to 15 headache days per month of which greater than or equal to 8 headache days on average across the 3 months meet criteria as migraine days
    2. EM is defined as less than 15 headache days per month of which at least 4 or more headache days on average across the 3 months meet criteria as migraine days

Exclusion Criteria:

  • Subjects greater than 50 years of age at migraine onset.
  • History of cluster headache or 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.
  • Malignancy, except non-melanoma skin cancers, cervical or breast ductal carcinoma in situ within the last 5 years.

Other exclusion criteria may apply


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): NCT03812224


Contacts
Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT03812224     History of Changes
Other Study ID Numbers: 20170609
First Posted: January 23, 2019    Key Record Dates
Last Update Posted: February 7, 2019
Last Verified: February 2019
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: http://www.amgen.com/datasharing

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

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