A Study With Eptinezumab in Adolescents (12-17 Years) With Chronic Migraine
- Registration Number
- NCT04965675
- Lead Sponsor
- H. Lundbeck A/S
- Brief Summary
To find out if eptinezumab is better than placebo (normal saline solution) in lowering the number of days with migraine in young people ages 12 to 17 with chronic migraine.
- Detailed Description
The study includes a single intravenous (IV) infusion of the study drug and consists of a screening period (4 weeks), a double-blind, placebo-controlled period (12 weeks), and a safety follow-up period (8 weeks). Participants confirmed eligible will be randomized (1:1:1) to receive a single IV infusion of either eptinezumab 300 milligrams (mg) dose (weight adjusted; targeting adult exposure after 300 mg IV), eptinezumab 100 mg (weight adjusted; targeting adult exposure after 100 mg IV), or placebo at randomization visit. The doses will be adjusted for the participant's body weight.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 285
- The participant has a diagnosis of migraine (with or without aura) as defined by International Classification of Headache Disorders 3 (ICHD-3) guidelines with history of chronic migraine, of at least 6 months prior to the screening visit.
- During the 28-day screening period, the participant must adequately complete the headache eDiary on at least 23 of the 28 days following the screening visit.
- During the 28-day screening period, the participant must have ≥15 to ≤26 headache days, of which at least 8 are migraine days as documented in the eDiary.
- The participant has previously been randomised in this study and exposed to eptinezumab.
- The participant has been exposed to any monoclonal antibody treatment (including exposure in a study) <6 months prior to the screening visit.
- The participant has been exposed to another calcitonin gene-related peptide (CGRP) antibody (including exposure in a study investigating a CGRP antibody) <6 months prior to the screening visit.
- The participant has a history or diagnosis of complicated migraine (ICHD-3 version, 2018), chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes such as hemiplegic migraine (sporadic and familial), migraine with brainstem aura, ophthalmoplegic migraine, or migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration; for example >60 minutes).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Eptinezumab 300 mg Eptinezumab Participants will receive a single IV infusion of eptinezumab 300 mg (weight adjusted). Placebo Placebo Participants will receive a single IV infusion of placebo matching to eptinezumab. Eptinezumab 100 mg Eptinezumab Participants will receive a single IV infusion of eptinezumab 100 mg (weight adjusted).
- Primary Outcome Measures
Name Time Method Change From Baseline in Monthly Migraine Days (MMDs) Averaged Over Weeks 1-12 Baseline, Weeks 1-12
- Secondary Outcome Measures
Name Time Method Percentage of Participants With 50% Reduction From Baseline in MMDs Averaged Over Weeks 1-12 Baseline up to Weeks 1-12 Percentage of Participants With Migraine on the Day After Dosing (Day 1) Day 1 Change From Baseline in Rate of Migraines With Severe Pain Intensity Averaged Over Weeks 1-12 Baseline, Weeks 1-12 Number of Participants With Specific Anti-Eptinezumab Antibodies (Anti-Drug Antibodies [ADA]) From randomization (Week 0) up to Week 20 Percentage of Participants With 50% Reduction From Baseline in MMDs Averaged Over Weeks 1-4 Baseline up to Weeks 1-4 Change From Baseline in MMDs With Use of Acute Medication Averaged Over Weeks 1-12 Baseline, Weeks 1-12 Percentage of Participants With 75% Reduction From Baseline in MMDs Averaged Over Weeks 1-4 Baseline up to Weeks 1-4 Percentage of Participants With 75% Reduction From Baseline in MMDs Averaged Over Weeks 1-12 Baseline up to Weeks 1-12 Change From Baseline in Monthly Headache Days Averaged Over Weeks 1-12 Baseline, Weeks 1-12 Change From Baseline in Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS) Score Averaged Over Weeks 1-12 Baseline, Weeks 1-12 Change From Baseline in Days With Use of Acute Medication Averaged Over Weeks 1-12 Baseline, Weeks 1-12 Number of Participants With Specific Anti-Eptinezumab Antibodies for Neutralizing Activity (NAb) From randomization (Week 0) up to Week 20 Free Eptinezumab Plasma Concentration Randomization ( pre-dose [Week 0]), Week 8, Week 12, and safety follow up visit (Week 20)
Trial Locations
- Locations (75)
Yale-New Haven Children's Hospital
🇺🇸New Haven, Connecticut, United States
Ki Health Partners LLC DBA New England Institute for Clinical Research
🇺🇸Stamford, Connecticut, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
NW FL Clinical Research Group, LLC
🇺🇸Gulf Breeze, Florida, United States
A G A Clinical Trials - HyperCore - PPDS
🇺🇸Hialeah, Florida, United States
Axcess Medical Research
🇺🇸Loxahatchee Groves, Florida, United States
University of South Florida
🇺🇸Tampa, Florida, United States
University of Kentucky HealthCare (UKHC) Kentucky Clinic
🇺🇸Lexington, Kentucky, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
Michigan Head Pain and Neurological Institute
🇺🇸Ann Arbor, Michigan, United States
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