A Study to Evaluate the Efficacy and Safety of Erenumab in Adults With Medication Overuse Headache
- Conditions
- Migraine Headache
- Interventions
- Registration Number
- NCT03971071
- Lead Sponsor
- Amgen
- 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).
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 620
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Erenumab 140 mg 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. Erenumab 70 mg 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. Placebo 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.
- Primary Outcome Measures
Name Time Method Number of Participants With Absence of Medication Overuse Headaches (MOH) at Month 6 Months 4, 5, and 6 (weeks 13 through 24) of the DBTP 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.
- Secondary Outcome Measures
Name Time Method Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP) 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.Number of Participants With Sustained MOH Remission at Month 6 Month 3 (week 12) to month 6 (week 24) of the DBTP 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).
Change From Baseline in Mean Monthly Average Physical Impairment Domain Scores as Measured by the Migraine Physical Function Impact Diary (MPFID) Baseline and months 4, 5, and 6 (weeks 13 through 24) of the DBTP 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.
Change From Baseline in Mean Monthly Average Impact on Everyday Activities Domain Scores as Measured by the MPFID Baseline and months 4, 5, and 6 (weeks 13 through 24) of the DBTP 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.
Change From Baseline in Mean Monthly AHMDs Over Months 4, 5, and 6 Baseline and months 4, 5, and 6 (weeks 13 through 24) of the DBTP 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.
Trial Locations
- Locations (94)
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, District of Columbia, United States
Floridian Clinical Research LLC
🇺🇸Miami Lakes, Florida, United States
University of Miami Miller School of Medicine
🇺🇸Miami, 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
Scroll for more (84 remaining)Core Healthcare Group🇺🇸Cerritos, California, United States