Open Actively Recruiting
Basimglurant in Children, Adolescents, and Young Adults With TSC
The study intends to show that basimglurant provides effective seizure control in children, adolescents and young adults with Tuberous Sclerosis Complex (TSC).
Inclusion Criteria (summary):
- Ability and willingness to provide informed assent or written consent or consent from their legal representative.
- Fluency in the language of the study staff
- Age 5 to 30 years at study entry
- A documented history of TSC
- Refractory seizure history
- Currently receiving one or more anti-epileptic drugs (AEDs)
- Stable medications or interventions for epilepsy
- Willingness to complete Patient Reported Outcome assessments
- For female patients of childbearing potential:
- Willingness to undergo serum or urinary pregnancy testing at screening and during the trial period.
- Willingness to use contraception.
Exclusion Criteria (summary):
- Neurologic disease other than TSC
- Recent anoxic episode
- Patient weight below 15kg
- Clinically significant unstable medical condition(s)
- Pregnancy or lactation
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Genetic and Rare Diseases
Pediatric and Prenatal Disorders
- UCLA Westwood