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Trial record 1 of 1 for:    20170703
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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 : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
Amgen

Tracking Information
First Submitted Date  ICMJE May 23, 2019
First Posted Date  ICMJE June 3, 2019
Last Update Posted Date April 8, 2021
Actual Study Start Date  ICMJE October 7, 2019
Estimated Primary Completion Date September 15, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 6, 2020)
Number of participants with absence of Medication Overuse Headache (MOH) at Month 6 [ Time Frame: Month 6 (week 24) of the double-blind treatment period ]
Absence of medication overuse headache (MOH) at month 6 is defined as a mean monthly acute headache medication days (AHMD) < 10 days over months 4, 5, and 6 (week 13 through 24) OR mean monthly headache days (MHD) < 14 days over months 4, 5, and 6 (week 13 through 24) of the double-blind treatment period (DBTP) where AHMD include any eDiary day in which an acute headache medication intake is reported.
Original Primary Outcome Measures  ICMJE
 (submitted: May 31, 2019)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2020)
  • Number of participants with change from baseline in mean monthly acute headache medication days (AHMD) [ Time Frame: Over Months 4, 5, and 6 (week 13 through 24) of the double-blind treatment phase ]
    Change from baseline in mean monthly AHMD over months 4, 5, and 6 (week 13 through 24) of the DBTP.
  • Number of participants with sustained Medication Overuse Headache (MOH) remission [ Time Frame: Over Months 3 (week 12) and 6 (week 24) of the double-blind treatment phase ]
    Sustained MOH remission during DBTP, as defined by absence of MOH at months 3 (week 12) and 6 (week 24) 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.
  • Number of participants with change from baseline in mean monthly average physical impairment domain scores as measured by the migraine physical function impact diary (MPFID) [ Time Frame: Over Months 4, 5, and 6 (week 13 through 24) 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 (week 13 through 24) of the DBTP.
  • 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 (week 13 through 24) 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 (week 13 through 24) of the DBTP.
  • Number of participants with change from baseline in mean HIT-6 score [ Time Frame: Over Months 4, 5, and 6 (week 13 through 24) of the double-blind treatment phase ]
    Change from baseline in mean HIT-6 score over months 4, 5, and 6 (week 13 through 24) of the DBTP.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 31, 2019)
  • 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
  • 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
  • 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
  • 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
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Efficacy and Safety of Erenumab in Adults With Medication Overuse Headache
Official Title  ICMJE 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
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).
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Migraine Headache
Intervention  ICMJE
  • Drug: Erenumab 70 mg
    Erenumab once every 4 weeks. Subcutaneous injection.
    Other Name: Aimovig
  • Drug: Erenumab 140mg
    Erenumab once every 4 weeks. Subcutaneous injection.
    Other Name: Aimovig
  • Drug: Placebo
    Placebo once every 4 weeks. Subcutaneous injection.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Placebo
  • Active Comparator: 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.
    Intervention: Drug: Erenumab 70 mg
  • Active Comparator: 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.
    Intervention: Drug: Erenumab 140mg
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 31, 2019)
687
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 30, 2023
Estimated Primary Completion Date September 15, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 prior to start of baseline
  • 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 preventive treatment
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com
Listed Location Countries  ICMJE Australia,   Austria,   Czechia,   Finland,   France,   Hungary,   Italy,   Poland,   Portugal,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03971071
Other Study ID Numbers  ICMJE 20170703
2018-003342-16 ( 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  ICMJE
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 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 URL below.
URL: http://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 April 2021

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