Basimglurant in Children and Adolescents With TSC

• Status: Not yet recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Noema Pharma AG

Criteria

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:

1. Willingness to undergo serum or urinary pregnancy testing at screening and during the trial period.

2. 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.