Longterm, openlabel (doseblinded), extension study of eptinezumab in children and adolescents with chronic or episodic migraine

Trial ID: 2022-502917-27-00
Protocol: 19379A
Sponsor: H. Lundbeck A/S

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Diseases & Conditions

Migraine

Objectives

The primary objective of this study is to evaluate the long-term safety of eptinezumab in pediatric and adolescent patients aged 6 to 17 years diagnosed with migraine, encompassing both chronic and episodic presentations. This assessment is clinically significant for establishing the longitudinal tolerability profile of the intravenous calcitonin gene-related peptide antagonist in this specific age demographic.

Participants

This study involves a total of 458 participants diagnosed with migraine. The study population consists of children and adolescents, specifically including both male and female individuals within the age range of 6 to 17 years. Participants are selected based on the requirement that they have completed the 12-week visit of either Study 19356A for chronic migraine or Study 19357A for episodic migraine immediately preceding enrollment into this open-label extension study.

Plans and Procedures

This Phase 5, open-label, dose-blinded, extension study is designed to evaluate the long-term safety of eptinezumab in children and adolescents aged 6 to 17 years diagnosed with migraine. Participation requires the prior completion of the Week 12 visit in either Study 19356A or Study 19357A. The primary objective is to monitor the frequency of treatment-emergent adverse events. Secondary endpoints include the assessment of free eptinezumab plasma concentration, the presence of anti-drug antibodies, and the evaluation of neutralizing activity. Additionally, changes from baseline in the Pediatric Migraine Disability Assessment Questionnaire score will be measured at weeks 12, 24, and 36. The study protocol involves an initial enrollment period followed by scheduled follow-up visits and an end-of-study visit to monitor safety and efficacy over the extension period.

Treatment

The investigational medicinal product is eptinezumab, provided as VYEPTI 100 mg concentrate for solution for infusion. The administered dosage is 300 mg via intravenous use.

Efficacy

Efficacy assessment in this clinical trial involves evaluating the change from baseline in the Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS) score. Measurements of this parameter are planned at week 12, week 24, and week 36.

Inclusion and Exclusion Criteria

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Inclusion Criteria

The patient must have completed Week 12 (completion) Visit of either Study 19356A (CM) or Study 19357A (EM) immediately prior to enrolment into this OLE study.

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Exclusion Criteria

The patient 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.
During lead-in Study19356A or Study19357A: - participant experienced anaphylactic 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.