A Phase 3 Study of Erenumab in Children with Chronic 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 Chronic Migraine.
IRAS ID
262647
Contact name
Ming Lim
Contact email
Sponsor organisation
Amgen Ltd
Eudract number
2017-002399-23
Duration of Study in the UK
5 years, 4 months, 15 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 chronic migraine. Chronic migraine is characterised by greater 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 chronic migraine in adults and has demonstrated a favourable benefit-risk profile for the prevention of migraine in adults.
This study is being done to learn more about erenumab in children and adolescent patients with chronic migraine. It will also see if erenumab prevents migraine, is safe and well tolerated in children and adolescents and whether it causes any side effects. This study will also look at what doses of erenumab are safe and effective for children and adolescents to take.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
19/EM/0140
Date of REC Opinion
14 Jun 2019
REC opinion
Further Information Favourable Opinion