REJOIN
Research type
Research Study
Full title
Long-term, open-label (dose-blinded), extension study of eptinezumab in children and adolescents with chronic or episodic migraine
IRAS ID
1005058
Contact name
Charlotte Jack
Contact email
Sponsor organisation
H. Lundbeck A/S
Eudract number
2020-001649-38
Clinicaltrials.gov Identifier
NCT05164172
Research summary
Frequent migraine and chronic migraine have been shown to cause significant adverse impact on quality of life of children and adolescents, including impairments in school performance.
Studies have suggested that not only can untreated or ineffectively treated migraines become progressively worse but may cause long-term neurological changes. Early intervention in childhood has the potential to interrupt this progression and eliminate long-term suffering and neurological changes.
Eptinezumab is an investigational drug being developed by H. Lundbeck A/S for the prevention of migraine. Eptinezumab has been shown to reduce the occurrence of headaches and migraine in adult patients and was approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom as a treatment for migraine prevention in adults in January 2022.
The purpose of this study (referred to as an extension study) is to assess how safe and well tolerated eptinezumab is when given to participants 6-17 years of age that have a diagnosis of migraine.
Approximately 645 participants from two lead-in studies for chronic migraine and episodic migraine will be enrolled across multiple sites globally, with an overall participation of 44 weeks.
Participants will receive the active study drug, Eptinezumab three times via intravenous (IV) infusion.
REC name
London - Hampstead Research Ethics Committee
REC reference
22/LO/0342
Date of REC Opinion
27 Jun 2022
REC opinion
Further Information Favourable Opinion