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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03971071




Registration number
NCT03971071
Ethics application status
Date submitted
23/05/2019
Date registered
3/06/2019

Titles & IDs
Public title
A Study to Evaluate the Efficacy and Safety of Erenumab in Adults With Medication Overuse Headache
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
Secondary ID [1] 0 0
2018-003342-16
Secondary ID [2] 0 0
20170703
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Migraine Headache 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Mental Health 0 0 0 0
Addiction
Public Health 0 0 0 0
Other public health

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Absence of Medication Overuse Headaches (MOH) at Month 6
Timepoint [1] 0 0
Months 4, 5, and 6 (weeks 13 through 24) of the DBTP
Secondary outcome [1] 0 0
Change From Baseline in Mean Monthly AHMDs Over Months 4, 5, and 6
Timepoint [1] 0 0
Baseline and months 4, 5, and 6 (weeks 13 through 24) of the DBTP
Secondary outcome [2] 0 0
Number of Participants With Sustained MOH Remission at Month 6
Timepoint [2] 0 0
Month 3 (week 12) to month 6 (week 24) of the DBTP
Secondary outcome [3] 0 0
Change From Baseline in Mean Monthly Average Physical Impairment Domain Scores as Measured by the Migraine Physical Function Impact Diary (MPFID)
Timepoint [3] 0 0
Baseline and months 4, 5, and 6 (weeks 13 through 24) of the DBTP
Secondary outcome [4] 0 0
Change From Baseline in Mean Monthly Average Impact on Everyday Activities Domain Scores as Measured by the MPFID
Timepoint [4] 0 0
Baseline and months 4, 5, and 6 (weeks 13 through 24) of the DBTP
Secondary outcome [5] 0 0
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Timepoint [5] 0 0
Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP)

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

Key
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/10/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/06/2023
Sample size
Target
Accrual to date
Final
620
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Holdsworth House Medical Practice - Sydney
Recruitment hospital [2] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Sydney
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
District of Columbia
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Idaho
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Kansas
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Louisiana
Country [9] 0 0
United States of America
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Massachusetts
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United States of America
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Michigan
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United States of America
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Minnesota
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United States of America
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Missouri
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United States of America
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New Hampshire
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United States of America
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New York
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United States of America
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North Carolina
Country [16] 0 0
United States of America
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Ohio
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United States of America
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Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
Tennessee
Country [19] 0 0
United States of America
State/province [19] 0 0
Texas
Country [20] 0 0
United States of America
State/province [20] 0 0
Utah
Country [21] 0 0
United States of America
State/province [21] 0 0
West Virginia
Country [22] 0 0
United States of America
State/province [22] 0 0
Wisconsin
Country [23] 0 0
Austria
State/province [23] 0 0
Innsbruck
Country [24] 0 0
Austria
State/province [24] 0 0
Klagenfurt
Country [25] 0 0
Austria
State/province [25] 0 0
Linz
Country [26] 0 0
Austria
State/province [26] 0 0
Wien
Country [27] 0 0
Czechia
State/province [27] 0 0
Brno
Country [28] 0 0
Czechia
State/province [28] 0 0
Praha 2
Country [29] 0 0
Czechia
State/province [29] 0 0
Praha 4
Country [30] 0 0
Czechia
State/province [30] 0 0
Praha
Country [31] 0 0
Czechia
State/province [31] 0 0
Prerov
Country [32] 0 0
Czechia
State/province [32] 0 0
Rychnov nad Kneznou
Country [33] 0 0
Finland
State/province [33] 0 0
Helsinki
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Finland
State/province [34] 0 0
Oulu
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Finland
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Tampere
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Finland
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Turku
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France
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Bron cedex
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France
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Lille
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France
State/province [39] 0 0
Marseille cedex 05
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France
State/province [40] 0 0
Nice cedex 1
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France
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Paris
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France
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Poitiers Cedex
Country [43] 0 0
France
State/province [43] 0 0
Pringy Cedex
Country [44] 0 0
France
State/province [44] 0 0
Saint-Etienne cedex 2
Country [45] 0 0
Hungary
State/province [45] 0 0
Budapest
Country [46] 0 0
Hungary
State/province [46] 0 0
Debrecen
Country [47] 0 0
Hungary
State/province [47] 0 0
Miskolc
Country [48] 0 0
Hungary
State/province [48] 0 0
Szeged
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Italy
State/province [49] 0 0
Bologna
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Italy
State/province [50] 0 0
Catanzaro
Country [51] 0 0
Italy
State/province [51] 0 0
Firenze
Country [52] 0 0
Italy
State/province [52] 0 0
Milano
Country [53] 0 0
Italy
State/province [53] 0 0
Palermo
Country [54] 0 0
Italy
State/province [54] 0 0
Pavia
Country [55] 0 0
Italy
State/province [55] 0 0
Roma
Country [56] 0 0
Poland
State/province [56] 0 0
Ksawerow
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Poland
State/province [57] 0 0
Legionowo
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Poland
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Lodz
Country [59] 0 0
Poland
State/province [59] 0 0
Poznan
Country [60] 0 0
Poland
State/province [60] 0 0
Sochaczew
Country [61] 0 0
Portugal
State/province [61] 0 0
Amadora
Country [62] 0 0
Portugal
State/province [62] 0 0
Lisboa
Country [63] 0 0
Portugal
State/province [63] 0 0
Torres Vedras
Country [64] 0 0
Spain
State/province [64] 0 0
Andalucía
Country [65] 0 0
Spain
State/province [65] 0 0
Aragón
Country [66] 0 0
Spain
State/province [66] 0 0
Castilla León
Country [67] 0 0
Spain
State/province [67] 0 0
Cataluña
Country [68] 0 0
Spain
State/province [68] 0 0
Comunidad Valenciana
Country [69] 0 0
United Kingdom
State/province [69] 0 0
Glasgow
Country [70] 0 0
United Kingdom
State/province [70] 0 0
Hull
Country [71] 0 0
United Kingdom
State/province [71] 0 0
Liverpool
Country [72] 0 0
United Kingdom
State/province [72] 0 0
London
Country [73] 0 0
United Kingdom
State/province [73] 0 0
Newcastle Upon Tyne
Country [74] 0 0
United Kingdom
State/province [74] 0 0
Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
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.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://www.amgen.com/datasharing


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03971071