Basimglurant in children, adolescents, and young adults with Tuberous Sclerosis Complex
Research type
Research Study
Full title
A Phase 2B, Multicenter, 30-week, Prospective, Cross-over, Doubleblind, Randomized, Placebo-controlled Study Followed by a 52-Week Open-label Extension Study to Evaluate the Efficacy and Safety of Basimglurant Adjunctive to Ongoing Anticonvulsive Therapy in Children, Adolescents, and Young Adults with Seizures Associated with Tuberous Sclerosis Complex.
IRAS ID
1006415
Contact name
Petya Koleva
Contact email
Sponsor organisation
Noema Pharma
Eudract number
2021-000838-34
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to test basimglurant (earlier known as NOE-101). Basimglurant is a new drug that is being developed for treating people with seizures due to Tuberous Sclerosis Complex (TSC). The goal of this study is to see how well basimglurant, when given together with ongoing treatment for seizures, helps in reducing the number of seizures and also for how long people remain free of seizures. Another goal of this study is to test the safety of basimglurant and to find out how the body handles the study drug at different dose levels when given along with the ongoing treatment.
About 54 participants who are 5 to 30 years old including children, adolescents and young adults will take part in this study.REC name
Wales REC 3
REC reference
22/WA/0354
Date of REC Opinion
19 Apr 2023
REC opinion
Further Information Favourable Opinion