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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03971071
Registration number
NCT03971071
Ethics application status
Date submitted
23/05/2019
Date registered
3/06/2019
Date last updated
20/03/2024
Titles & IDs
Public title
A Study to Evaluate the Efficacy and Safety of Erenumab in Adults With Medication Overuse Headache
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Scientific 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
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Secondary ID [1]
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2018-003342-16
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Secondary ID [2]
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20170703
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Migraine Headache
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Condition category
Condition code
Neurological
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Other neurological disorders
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Musculoskeletal
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0
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Other muscular and skeletal disorders
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Mental Health
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Addiction
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Public Health
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Other public health
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Erenumab 70 mg
Treatment: Drugs - Erenumab 140 mg
Treatment: Drugs - Placebo
Placebo Comparator: Placebo - After participants 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.
Active Comparator: Erenumab 70 mg - After participants 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.
Active Comparator: Erenumab 140 mg - After participants 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.
Treatment: Drugs: Erenumab 70 mg
Erenumab once every 4 weeks. Subcutaneous injection.
Treatment: Drugs: Erenumab 140 mg
Erenumab once every 4 weeks. Subcutaneous injection.
Treatment: Drugs: Placebo
Placebo once every 4 weeks. Subcutaneous injection.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Absence of Medication Overuse Headaches (MOH) at Month 6
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Assessment method [1]
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Absence of MOH at month 6 was defined as mean monthly acute headache medication days (AHMD) < 10 days over months 4, 5, and 6 (weeks 13 through 24) or mean monthly headache days < 14 days over months 4, 5, and 6 (weeks 13 through 24) of the DBTP where an AHMD was defined as a calendar day in which the participant took at least 1 acute headache medication.
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Timepoint [1]
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Months 4, 5, and 6 (weeks 13 through 24) of the DBTP
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Secondary outcome [1]
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Change From Baseline in Mean Monthly AHMDs Over Months 4, 5, and 6
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Assessment method [1]
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An AHMD was defined as a calendar day in which the participant takes at least 1 acute headache medication. Acute headache medications included triptan-based, ergotamine-based and ditan-based migraine medications, non-opioid and opioid-containing acute headache medications, non-opioid butalbital and opioid-containing butalbital containing medications.
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Timepoint [1]
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Baseline and months 4, 5, and 6 (weeks 13 through 24) of the DBTP
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Secondary outcome [2]
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Number of Participants With Sustained MOH Remission at Month 6
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Assessment method [2]
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Sustained MOH remission was defined as the absence of MOH at month 3 (week 12) and month 6 (week 24) of the DBTP. Absence of MOH was achieved when mean monthly AHMD < 10 days or mean monthly headache days < 14 days over the 3-month period (weeks 12 to 24).
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Timepoint [2]
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Month 3 (week 12) to month 6 (week 24) of the DBTP
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Secondary outcome [3]
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Change From Baseline in Mean Monthly Average Physical Impairment Domain Scores as Measured by the Migraine Physical Function Impact Diary (MPFID)
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Assessment method [3]
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The MPFID is a self-administered 13-item instrument measuring physical functioning, completed daily using the eDiary. The physical impairment domain includes 5 items. Participants respond to items using a 5-point scale, with difficulty items ranging from "Without any difficulty" to "Unable to do", and frequency items ranging from "None of the time" to "All of the time". Each item is assigned a score from 1 to 5, with 5 representing the greatest burden. For each domain, the scores are calculated as the sum of the item responses and the sum is rescaled to a 0 to 100 scale, with higher scores representing greater impact of migraine, i.e., higher burden.
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Timepoint [3]
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Baseline and months 4, 5, and 6 (weeks 13 through 24) of the DBTP
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Secondary outcome [4]
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Change From Baseline in Mean Monthly Average Impact on Everyday Activities Domain Scores as Measured by the MPFID
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Assessment method [4]
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The MPFID is a self-administered 13-item instrument measuring physical functioning, completed daily using the eDiary. The impact on everyday activities domain includes 7 items. Participants respond to items using a 5-point scale, with difficulty items ranging from "Without any difficulty" to "Unable to do", and frequency items ranging from "None of the time" to "All of the time". Each item is assigned a score from 1 to 5, with 5 representing the greatest burden. For each domain, the scores are calculated as the sum of the item responses and the sum is rescaled to a 0 to 100 scale, with higher scores representing greater impact of migraine, i.e., higher burden.
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Timepoint [4]
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Baseline and months 4, 5, and 6 (weeks 13 through 24) of the DBTP
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Secondary outcome [5]
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Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
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Assessment method [5]
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TEAEs were defined as any adverse event (AE) that started on or after first dose of IP, and up to the end of the study (52 weeks).
Any clinically significant changes in vital signs were included as TEAEs.
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Timepoint [5]
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Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP)
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Eligibility
Key inclusion 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, participants 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. Participants are eligible to be included in the study only if all of
the following criteria apply:
- Participant 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
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Minimum age
18
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Maximum age
99
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion Criteria Part 1
Participants 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 preventive 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-calcitonin gene-related peptide 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 participant 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 enrollment 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 nonsteroidal anti-inflammatory drugs 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 participant 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 participant self-report, medical records or
positivity on baseline pregnancy screening tests, through end of study
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
7/10/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
13/06/2023
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Sample size
Target
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Accrual to date
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Final
620
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Holdsworth House Medical Practice - Sydney
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Recruitment hospital [2]
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The Alfred Hospital - Melbourne
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Recruitment postcode(s) [1]
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2010 - Sydney
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Recruitment postcode(s) [2]
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3004 - Melbourne
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Recruitment outside Australia
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California
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Funding & Sponsors
Primary sponsor type
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Name
Amgen
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Ethics approval
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Summary
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 participants with
chronic migraine (CM) who have a history of at least 1 preventive treatment failure and are
diagnosed with medication overuse headache (MOH).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03971071
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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MD
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Amgen
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03971071
Download to PDF