Health TrialsbyHealthPanel

A Study With Eptinezumab in Children and Adolescents (6 to 17 Years) With Chronic or Episodic Migraine

ConditionMigraine
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age6-17
SponsorH. Lundbeck A/S

About this trial

The main goal of the study is to assess the long-term safety of eptinezumab on children and adolescents ages 6 to 17 with chronic or episodic migraine.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

The participant has an adverse event or other safety concerns that are deemed related to double-blind treatment received in the lead-in study and is considered a potential safety risk by the investigator.

participant experienced ananaphylactic reaction or another severe and/or serious hypersensitivity reaction to the investigational medicinal product (IMP) infusion, as assessed by the investigator

the participant had a serum alanine aminotransferase (ALT) or aspartate aminotransferase(AST) value >5 times the upper limit of the reference range that was confirmed by testing <2 weeks later.

the participant had a serum ALT or AST value >3times the upper limit of the reference range and a serum total bilirubin value >2times the upper limit of the reference range.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Eptinezumab

    Drug

    Concentrate for solution for infusion

Treatment groups

600 Participants
are divided into 2 treatment groups
Group A: Eptinezumab 300 mgExperimental treatment 1 intervention
Group B: Eptinezumab 100 mgExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of Participants With Treatment Emergent Adverse Events

Time frame
Baseline up to Week 44

Secondary outcomes

1

Free Eptinezumab Plasma Concentration

Time frame
Baseline, Weeks 8, 12, 24, 36, and 44
2

Number of Participants With Specific Anti-Eptinezumab Antibodies (Anti-Drug Antibodies [ADA])

Time frame
Baseline (Week 0), Weeks 8, 12, 24, 36, and 44
3

Number of Participants With Specific Anti-Eptinezumab Antibodies for Neutralizing Activity (NAb)

Time frame
Baseline (Week 0), Weeks 8, 12, 24, 36, and 44
4

Change From Baseline in Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS) Score at Weeks 12, 24, and 36

Time frame
Baseline, Weeks 12, 24, and 36

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

H. Lundbeck A/S

Lead sponsor

Source ClinicalTrials.gov
Apply now