Open Actively Recruiting

Basimglurant in Children and Adolescents With TSC

About

Brief Summary

The study intends to show that basimglurant provides effective seizure control in children and adolescents with Tuberous Sclerosis Complex (TSC).

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase II

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
5 Years
Maximum Age
18 Years

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 18 years
  • A documented history of TSC,
  • Refractory seizure treatment status
  • Currently receiving one or more anti-epileptic drugs (AEDs)
  • Stable medications or interventions for epilepsy
  • Willingness to complete Patient Reported Outcome
  • 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.

Join this Trial

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Study Stats
Protocol No.
21-001187
Category
Neurology
Pediatrics
Urology
Contact
Angela Martinez
Location
  • UCLA Westwood
For Providers
NCT No.
NCT05059327
For detailed technical eligibility, visit ClinicalTrials.gov.