A Phase 3 Study of Erenumab in Children with Episodic Migraine
Research type
Research Study
Full title
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Erenumab in Children (6 to < 12 Years) and Adolescents (12 to < 18 Years) With Episodic Migraine
IRAS ID
262646
Contact name
Ming Lim
Contact email
Sponsor organisation
Amgen Ltd
Eudract number
2017-002397-39
Duration of Study in the UK
4 years, 1 months, 17 days
Research summary
This study is going to evaluate the effect of Erenumab compared with placebo on the change in monthly migraine days in paediatric patients with episodic migraine. Episodic migraine is characterised by less than 15 headaches per month, with existing treatment having modest efficacy and being poorly tolerated. Most treatments currently used are approved only in adults. Migraine headaches are recurring and commonly incapacitating headaches with specific clinical pain features and symptoms. They commonly appear in childhood, increase in prevalence during adolescence and reach a peak in adult’s age 30-39yrs.
In children and adolescents, migraine impacts particularly school life (in terms of performance and lost days) and social life. Migraine treatment can be divided into acute treatment which focuses on reducing the pain and shortening the attack or preventative treatment to reduce the frequency and severity. With the exception of propranolol approved in Finland for children 7 years and older and topiramate approved in the US for children aged 12 years and older the safety and efficacy have not been established for other preventative agents used in the paediatric population.
Moreover, because of the side effects that those treatments can have on school and social life, there remains an unmet need for new migraine treatments for children and adolescents. Erenumab has been investigated for the prevention of episodic migraine in adults and has demonstrated a favourable benefit-risk profile for the prevention of migraine in adults. This study will evaluate the effect of Erenumab in paediatric patients with episodic migraine.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
19/EM/0139
Date of REC Opinion
14 Jun 2019
REC opinion
Further Information Favourable Opinion