PROSPECT-1
Research type
Research Study
Full title
Interventional, randomised, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of intravenous (IV) eptinezumab in paediatric patients (6 to 17 years) for the preventive treatment of episodic migraine
IRAS ID
1007319
Contact name
Lene Bech
Contact email
Sponsor organisation
H. Lundbeck A/S
Research summary
Frequent migraine has 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 the study is to see if eptinezumab, the study drug, can safely prevent headaches in children and adolescents 6-17 years of age that have a diagnosis of migraine with a history of migraine headaches for more than 6 months.
By comparing eptinezumab to a placebo we hope to see if eptinezumab is better than placebo at lowering the number of days with headaches. We will also be able to see if there are any side effects, also called adverse events, that are caused by eptinezumab.
Approximately 315 children and adolescents will be enrolled across multiple sites globally, with an overall participation of 24 weeks and the option to also participate in a separate extension study.
Participants will be randomly assigned to either receive the active study drug, Eptinezumab or placebo (a dummy treatment that contains no active ingredients) as one intravenous (IV) infusion.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
23/SC/0196
Date of REC Opinion
30 Aug 2023
REC opinion
Further Information Favourable Opinion