Skip to main content
MedPathMedPath Home
Clinical Trials/2024-510656-13-00
2024-510656-13-00
Recruiting
Phase 3

Interventional, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of IV eptinezumab in adolescents (12-17years) for the preventive treatment of chronic migraine.

H. Lundbeck A/S22 sites in 4 countries179 target enrollmentStarted: September 13, 2024Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit

Overview

Phase
Phase 3
Status
Recruiting
Enrollment
179
Locations
22
Primary Endpoint
"Change From Baseline in Monthly Migraine Days (MMDs) Averaged Over Weeks 1-12 "
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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.

Study Design

Allocation
Randomized
Primary Purpose
Safety follow up period
Masking
Double (Subject, Carer, Investigator, Monitor, Analyst)

Eligibility Criteria

Ages
0 years to 17 years (0-17 Years)
Accepts Healthy Volunteers
Yes

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 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.

Exclusion Criteria

  • •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).

Outcomes

Primary Outcomes

"Change From Baseline in Monthly Migraine Days (MMDs) Averaged Over Weeks 1-12 "

"Change From Baseline in Monthly Migraine Days (MMDs) Averaged Over Weeks 1-12 "

Secondary Outcomes

  • Percentage of Participants With 50% Reduction From Baseline in MMDs Averaged Over Weeks 1-12
  • Percentage of Participants With Migraine on the Day After Dosing (Day 1)
  • Change From Baseline in MMDs With Use of Acute Medication Averaged Over Weeks 1-12
  • Percentage of Participants With 75% Reduction From Baseline in MMDs Averaged Over Weeks 1-12
  • Percentage of Participants With 75% Reduction From Baseline in MMDs Averaged Over Weeks 1-4
  • Percentage of Participants With 50% Reduction From Baseline in MMDs Averaged Over Weeks 1-4
  • Change From Baseline in Monthly Headache Days Averaged Over Weeks 1-12
  • Change From Baseline in Rate of Migraines With Severe Pain Intensity Averaged Over Weeks 1-12
  • Change From Baseline in Days With Use of Acute Medication Averaged Over Weeks 1-12
  • Change From Baseline in Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS) Score Averaged Over Weeks 1-12
  • Free Eptinezumab Plasma Concentration
  • Number of Participants With Specific Anti-Eptinezumab Antibodies (Anti-Drug Antibodies [ADA])
  • Number of Participants With Specific Anti-Eptinezumab Antibodies for Neutralizing Activity (NAb)

Investigators

Sponsor Class
Pharmaceutical company
Responsible Party
Principal Investigator
Principal Investigator

Global Trial Lead

Scientific

H. Lundbeck A/S

Study Sites (22)

Loading locations...

Similar Trials

Active, not recruiting
Phase 3
Randomised placebo controlled clinical trial of efficacy of MYOcardial protection in postacute inFLAMmatory cardiac involvEment due to COVID-19 (MYOFLAME-19)
2024-516463-84-00Goethe University Frankfurt280
Completed
Phase 2
Dose ranging study of amlitelimab in adult participants with moderate-to-severe asthma
2024-510641-33-00Sanofi-Aventis Recherche & Developpement104
Active, not recruiting
Phase 3
A Study Evaluating the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for Participants With HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy (Astefania)
2023-503568-18-00F. Hoffmann-La Roche AG377
Recruiting
Phase 4
DUPI REDUCE trial (DUPIlumab dose REDUCtion in patients with controlled atopic Eczema): a multicenter, low-intervention, non-inferiority randomized controlled trial, embedded in the TREAT NL registry.
2023-504171-24-00Amsterdam UMC216
Completed
Phase 3
Ertugliflozin Pediatric Study
2022-501085-21-00Merck Sharp & Dohme LLC20