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Trial record 12 of 242 for:    Recruiting, Not yet recruiting, Available Studies | Headache

A Study to Evaluate the Efficacy and Safety of Erenumab in Adults With Medication Overuse Headache

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ClinicalTrials.gov Identifier: NCT03971071
Recruitment Status : Recruiting
First Posted : June 3, 2019
Last Update Posted : October 31, 2019
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
Study 20170703 is a phase 4, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of erenumab against placebo in subjects with chronic migraine (CM) who have a history of at least 1 preventive treatment failure and are diagnosed with medication overuse headache (MOH).

Condition or disease Intervention/treatment Phase
Migraine Headache Drug: Erenumab 70 mg Drug: Erenumab 140mg Drug: Placebo Phase 4

Detailed Description:

Study 20170703 is a phase 4, randomized, double-blind, double-dummy, parallel-group, placebo-controlled study to evaluate the safety and efficacy of erenumab against placebo in a chronic migraine (CM) population with medication overuse headache (MOH) and prior history of treatment failure. Subjects will be enrolled based on fulfilment of the International Classification of Headache Disorders, 3rd Edition (ICHD-3) CM and MOH criteria and will not be advised to early discontinue acute medication.

Subjects who successfully complete the 24-week double-blind treatment period (DBTP) of the study will be offered an opportunity to continue in an open-label treatment period (OLTP) of 28-weeks duration. Subjects who received erenumab treatment during the DBTP will continue to receive the same erenumab dose during the OLTP. Subjects who received placebo during the DBTP will be allocated in a 1:1 ratio to receive either erenumab 70 mg or 140 mg SC QM during the OLTP. All subjects will remain blinded to their original DBTP treatment assignment.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 687 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 4, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Erenumab in Adults With Chronic Migraine and Medication Overuse Headache
Actual Study Start Date : October 7, 2019
Estimated Primary Completion Date : November 16, 2021
Estimated Study Completion Date : May 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
After subjects complete the baseline period and are found eligible, they will be enrolled and randomized in a 1:1:1 ratio to either erenumab (70mg or 140 mg) or placebo.
Drug: Placebo
Placebo once every 4 weeks. Subcutaneous injection.

Experimental: Erenumab 70 mg
After subjects complete the baseline period and are found eligible, they will be enrolled and randomized in a 1:1:1 ratio to either erenumab (70 mg or 140 mg) or placebo.
Drug: Erenumab 70 mg
Erenumab once every 4 weeks. Subcutaneous injection.
Other Name: Aimovig

Experimental: Erenumab 140 mg
After subjects complete the baseline period and are found eligible, they will be enrolled and randomized in a 1:1:1 ratio to either erenumab (70mg or 140 mg) or placebo.
Drug: Erenumab 140mg
Erenumab once every 4 weeks. Subcutaneous injection.
Other Name: Aimovig




Primary Outcome Measures :
  1. Number of participants with absence of Medication Overuse Headache (MOH) at Month 6 [ Time Frame: Month 6 of the double-blind treatment period ]
    Absence of medication overuse headache (MOH) at month 6 is defined as a mean monthly treatment acute headache medication days (AHMD) < 10 days over months 4, 5, and 6 OR mean monthly headache days (MHD) < 14 days over months 4, 5, and 6 of the double-blind treatment period where AHMD include any eDiary day in which an acute headache medication intake is reported.


Secondary Outcome Measures :
  1. Number of participants with change from baseline in mean monthly acute headache medication days (AHMD) [ Time Frame: Over Months 4, 5, and 6 of the double-blind treatment phase ]
    Change from baseline in mean monthly AHMD over months 4, 5, and 6 of the DBTP

  2. Number of participants with sustained Medication Overuse Headache (MOH) remission [ Time Frame: Over Months 3 and 6 of the double-blind treatment phase ]
    Sustained MOH remission during DBTP, as defined by absence of MOH at months 3 and 6 of the DBTP, and "absence of MOH" is achieved when mean monthly AHMD < 10 days OR mean MHD < 14 days over the respective 3-month period

  3. Number of participants with change from baseline in mean monthly average physical impairment domain scores as measured by the MPFID [ Time Frame: Over Months 4, 5, and 6 of the double-blind treatment phase ]
    Change from baseline in mean monthly average physical impairment domain scores as measured by the MPFID over months 4, 5, and 6 of the DBTP

  4. Number of participants with change from baseline in mean monthly average impact on everyday activities domain scores as measured by the MPFID [ Time Frame: Over Months 4, 5, and 6 of the double-blind treatment phase ]
    Change from baseline in mean monthly average impact on everyday activities domain scores as measured by the MPFID over months 4, 5, and 6 of the DBTP

  5. Number of participants with change from baseline in mean HIT-6 score [ Time Frame: Over Months 4, 5, and 6 of the double-blind treatment phase ]
    Change from baseline in mean HIT-6 score over months 4, 5, and 6 of the DBTP



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

Eligibility criteria will be evaluated during the up to 3-week screening period (part 1) and a 4-week baseline period (part 2). At the end of baseline period, subjects who successfully met eligibility criteria will be randomized on study.

Key Inclusion Criteria Part 1: To be assessed during the 3-week screening period, prior to the baseline period. Subjects are eligible to be included in the study only if all of the following criteria apply:

  • Subject has provided informed consent prior to initiation of any study-specific activities/procedures
  • Age ≥ 18 years on entry into the study
  • Documented history of migraine without aura and/or migraine with aura according to the ICHD-3 classification for ≥ 12 months at screening
  • Documented history of CM for a minimal duration of 6 months before screening
  • Current diagnosis of MOH
  • History of treatment failure with at least 1 preventive treatment as defined as treatment discontinuation due to lack of efficacy, adverse event or general poor tolerability

Key Exclusion Criteria Part 1

Subjects are excluded from the study if any of the following criteria apply:

Disease Related

  • Age > 50 years at migraine onset or > 65 years at CM onset
  • History of hemiplegic migraine, cluster headache or other trigeminal autonomic cephalalgia
  • Current concomitant diagnosis of a secondary type of headache other than MOH
  • No therapeutic response in prevention of migraine after an adequate therapeutic trial of > 3 preventative treatment categories
  • Changes in drug regimen (ie, changes in dose or frequency of use) of an allowed migraine preventive medication within 2 months from screening
  • Received botulinum toxin in the head and/or neck region within 4 months prior to screening
  • Documented history of treatment with an anti-CGRP product
  • Anticipated to require any excluded medication/device or procedure during the study

Other Medical Conditions

  • History or evidence of unstable or clinically significant medical condition that, in the opinion of the investigator or Amgen's physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
  • Evidence of "recreational use" of illicit drugs within 12 months prior to screening, based on medical records, self-report, or a positive drug test performed during screening.

Key Inclusion Criteria Part 2. To be assessed at the end of the baseline period and prior to enrolment into DBTP. Based on information collected through the electronic diary (eDiary) during the baseline period, the following requirements must be met:

-≥ 14 headache days during the 28-day baseline period out of which ≥ 8 headache days meet criteria as migraine days

  • Observation of acute migraine medication overuse during the baseline period. Medication overuse at baseline is defined as:

    • ≥ 10 days of combination treatment OR
    • ≥ 10 days of short-acting opioids/opioid-containing medication OR
    • ≥ 10 days of triptans, ergots, OR
    • ≥ 15 days of NSAIDs or simple analgesics intake
  • At least 2 acute headache medication days per week for each week with at least 5 diary days
  • Demonstrated at least 80% compliance with the eDiary (eg, must complete eDiary items on at least 23 out of 28 days during the baseline period)

Key Exclusion Criteria Part 2

Study Procedures

  • Changed or planning to change the dose of an allowed concomitant medication that may have migraine preventive effect during baseline period or post-randomization
  • Unstable or clinically significant medical condition 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

Contraception, pregnancy or breastfeeding

  • Unwillingness to maintain acceptable contraception method, when applicable
  • Evidence of pregnancy or breastfeeding per subject self-report, medical records or positivity on baseline pregnancy screening tests, through end of 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): NCT03971071


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

Locations
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United States, California
Research Site Recruiting
Santa Monica, California, United States, 90404
United States, District of Columbia
Research Site Recruiting
Washington, District of Columbia, United States, 20037
United States, Florida
Research Site Recruiting
Tampa, Florida, United States, 33612
United States, Kansas
Research Site Recruiting
Overland Park, Kansas, United States, 66212
United States, Louisiana
Research Site Recruiting
New Orleans, Louisiana, United States, 70124
United States, Michigan
Research Site Recruiting
Ann Arbor, Michigan, United States, 48104
United States, Minnesota
Research Site Recruiting
Minneapolis, Minnesota, United States, 55402
United States, Missouri
Research Site Recruiting
Bolivar, Missouri, United States, 65613
Research Site Recruiting
Saint Louis, Missouri, United States, 63141
United States, New York
Research Site Recruiting
Amherst, New York, United States, 14226
United States, Pennsylvania
Research Site Recruiting
Pittsburgh, Pennsylvania, United States, 15236
United States, Tennessee
Research Site Recruiting
Nashville, Tennessee, United States, 37203
Australia, New South Wales
Research Site Recruiting
Sydney, New South Wales, Australia, 2010
Poland
Research Site Recruiting
Legionowo, Poland, 05-120
Research Site Recruiting
Lodz, Poland, 90-338
Research Site Recruiting
Poznan, Poland, 60-848
Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen

Additional Information:
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT03971071     History of Changes
Other Study ID Numbers: 20170703
2018-003342-16 ( EudraCT Number )
First Posted: June 3, 2019    Key Record Dates
Last Update Posted: October 31, 2019
Last Verified: October 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 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. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. 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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amgen:
Chronic Migraine (CM)
Medication Overuse Headache (MOH)
Additional relevant MeSH terms:
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Headache Disorders, Secondary
Headache
Headache Disorders, Primary
Headache Disorders
Migraine Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Erenumab
Antibodies, Monoclonal
Calcitonin Gene-Related Peptide Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Immunologic Factors