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

  • STATUS
    Recruiting
  • End date
    Mar 30, 2023
  • participants needed
    687
  • sponsor
    Amgen
Updated on 4 November 2020
Investigator
Amgen Call Center
Primary Contact
Research Site (7.3 mi away) Contact
+75 other location
headache
erenumab
chronic migraine
migraine with aura
common migraine

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).

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.

Details
Treatment Placebo, Erenumab 70 mg, Erenumab 140mg
Clinical Study IdentifierNCT03971071
SponsorAmgen
Last Modified on4 November 2020

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Eligibility

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Inclusion Criteria

Is your age between 18 yrs and 99 yrs?
Gender: Male or Female
Do you have any of these conditions: Migraine and Cluster Headaches or Migraine (Pediatric) or Migraine (Adult) or Primary Stabbing Headache or Migraine?
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
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
days of combination treatment OR
days of short-acting opioids/opioid-containing medication OR
days of triptans, ergots, OR
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
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