Treatment Resistant Infantile Spasms (TRIS Study)
Research type
Research Study
Full title
An Open-Label Adaptive Study For The Assessment of Safety, Tolerability, Pharmacokinetics, and Efficacy of Multiple Doses of Radiprodil in Subjects with Drug-Resistant Infantile Spasms
IRAS ID
210033
Contact name
Minal Kara
Contact email
Sponsor organisation
UCB Biopharma SRPL
Eudract number
2016-002107-26
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 2 months, 0 days
Research summary
Infantile spasms (IS) (also known as West syndrome) is a rare and very severe epilepsy condition with onset in the first 12 months of life. It is characterised by a unique seizure type (spasms) and severely abnormal brain activity. A number of underlying conditions cause infantile spasms, these include brain injury at birth, growths or damage within the brain, or genetic conditions. The underlying conditions, combined with spasms and abnormal brain activity have a detrimental effect on the development of the affected children, often resulting in severe learning disability and/or lifelong epilepsy.
Prompt and efficient treatment of spasms with medications results in better developmental outcomes. The currently approved (standard of care) medications for IS are relatively effective, however approximately 30% of patients fail to respond and they are at risk of developing severe learning disability and other types of seizures. Novel medications are therefore needed to address the need of the patients who are resistant to approved medications.
UCB are initiating a study to test the safety and efficacy of a novel medication – radiprodil - in infantile spasms, resistant to standard of care treatments. Radiprodil acts by inhibiting a receptor in the brain that is predominant in infancy, but not later in life.
The study with radiprodil will be initiated in the UK and Belgium. Patients with infantile spasms aged 2 to 14 months who are not responding to standard of care treatments will be recruited. Radiprodil will be given for a period of approximately 4-6 weeks during which the child will be staying in hospital with continuous intensive monitoring. The study will offer the children with ongoing infantile spasms the opportunity to take a novel medication which may have efficacy when the current standard of care has failed.REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
16/LO/1602
Date of REC Opinion
24 Oct 2016
REC opinion
Further Information Favourable Opinion