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).
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 CM population with MOH and prior history of treatment failure. Participants 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. Participants 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. Participants who received erenumab treatment during the DBTP will continue to receive the same erenumab dose during the OLTP. Participants 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 participants will remain blinded to their original DBTP treatment assignment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
620
Erenumab once every 4 weeks. Subcutaneous injection.
Erenumab once every 4 weeks. Subcutaneous injection.
Placebo once every 4 weeks. Subcutaneous injection.
Number of Participants With Absence of Medication Overuse Headaches (MOH) at Month 6
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.
Time frame: Months 4, 5, and 6 (weeks 13 through 24) of the DBTP
Change From Baseline in Mean Monthly AHMDs Over Months 4, 5, and 6
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.
Time frame: Baseline and months 4, 5, and 6 (weeks 13 through 24) of the DBTP
Number of Participants With Sustained MOH Remission at Month 6
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).
Time frame: Month 3 (week 12) to month 6 (week 24) of the DBTP
Change From Baseline in Mean Monthly Average Physical Impairment Domain Scores as Measured by the Migraine Physical Function Impact Diary (MPFID)
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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Core Healthcare Group
Cerritos, California, United States
Axiom Research
Colton, California, United States
Clinical Research Institute
Los Angeles, California, United States
The George Washington Medical Faculty Associates
Washington D.C., District of Columbia, United States
University of Miami Miller School of Medicine
Miami, Florida, United States
Floridian Clinical Research LLC
Miami Lakes, Florida, United States
Clinical Neuroscience Solutions
Orlando, Florida, United States
Emerald Coast Center for Neurological Disorders
Pensacola, Florida, United States
University of South Florida
Tampa, Florida, United States
Saint Lukes Clinic
Meridian, Idaho, United States
...and 84 more locations
Time frame: Baseline and months 4, 5, and 6 (weeks 13 through 24) of the DBTP
Change From Baseline in Mean Monthly Average Impact on Everyday Activities Domain Scores as Measured by the MPFID
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.
Time frame: Baseline and months 4, 5, and 6 (weeks 13 through 24) of the DBTP
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
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.
Time frame: Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP)