Migraine MedDRA version: 20.0 Level: PT Classification code 10027599 Term: Migraine System Organ Class: 10029205 - Nervous system disorders
Conditions
Sponsors
H. Lundbeck A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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 24 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. Are the trial subjects under 18? yes Number of subjects for this age range: 285 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - The participant has previously been enrolled 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: To evaluate the population pharmacokinetics and immunogenicity of eptinezumab administered IV to patients 12 to 17 years of age with CM;Primary end point(s): 1. Change From Baseline in Monthly Migraine Days (MMDs) Averaged Over Weeks 1-12 ;Timepoint(s) of evaluation of this end point: 1. Time Frame: Baseline, Weeks 1-12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Percentage of Participants With 50% Reduction From Baseline in MMDs Averaged Over Weeks 1-12 2. Percentage of Participants With Migraine on the Day After Dosing (Day 1) 3. Change From Baseline in MMDs With Use of Acute Medication Averaged Over Weeks 1-12 4. Percentage of Participants With 75% Reduction From Baseline in MMDs Averaged Over Weeks 1-12 5. Percentage of Participants With 75% Reduction From Baseline in MMDs Averaged Over Weeks 1-4 6. Percentage of Participants With 50% Reduction From Baseline in MMDs Averaged Over Weeks 1-4 7. Change From Baseline in Monthly Headache Days Averaged Over Weeks 1-12 8. Change From Baseline in Rate of Migraines With Severe Pain Intensity Averaged Over Weeks 1-12 9. Change From Baseline in Days With Use of Acute Medication Averaged Over Weeks 1-12 10. Change From Baseline in Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS) Score Averaged Over Weeks 1-12 11. Free Eptinezumab Plasma Concentration 12. Number of Participants With Specific Anti-Eptinezumab Antibodies (Anti-Drug Antibodies [ADA]) 13. Number of Participants With Specific Anti-Eptinezumab Antibodies for Neutralizing Activity (NAb) ;Timepoint(s) of evaluation of this end point: 1. Time Frame: Baseline up to Weeks 1-12 2. Time Frame: Day 1 3. Time Frame: Baseline, Weeks 1-12 4. Time Frame: Baseline up to Weeks 1- 12 5. Time Frame: Baseline up to Weeks 1-4 6. Time Frame: Baseline up to Weeks 1-4 7. Time Frame: Baseline, Weeks 1-12 8. Time Frame: Baseline, Weeks 1-12 9. Time Frame: Baseline, Weeks 1-12 10. Time Frame: Baseline, Weeks 1-12 11. Time Frame: Randomization ( pre-dose [Week 0]), Week 8, Week 12, and safety follow up visit (Week 20) 12. Time Frame: From randomization (Week 0) up to Week 20 13. Time Frame: From randomization (Week 0) up to Week 20 | — |
Countries
Argentina, Canada, Italy, Mexico, Portugal, Serbia, Spain, Turkey, United Kingdom, United States
Contacts
Public ContactLundbeckClinicalTrials@lundbeck.com
H. Lundbeck A/S
Outcome results
None listed