Basimglurant for Tuberous Sclerosis

Recruiting in Palo Alto (17 mi)

+65 other locations

Age: < 65

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Noema Pharma AG

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing basimglurant, a medicine that helps control seizures, in children, adolescents, and young adults with Tuberous Sclerosis Complex (TSC). Basimglurant works by blocking a specific receptor in the brain, which helps reduce seizures. The goal is to find the best dose that reduces seizures while being safe for patients.

Eligibility Criteria

This trial is for children, adolescents, and young adults aged 5 to 30 with Tuberous Sclerosis Complex (TSC) who have seizures not controlled by current medications. Participants must be fluent in the study staff's language, on stable epilepsy treatments, and willing to undergo pregnancy tests if applicable. Those under 15kg or with other significant medical conditions are excluded.

Inclusion Criteria

I am between 5 and 30 years old.

My seizures do not respond to treatment.

I am currently taking medication for epilepsy.

My epilepsy treatment has been consistent without changes.

I have been diagnosed with Tuberous Sclerosis Complex (TSC).

Exclusion Criteria

I have a neurological condition that is not tuberous sclerosis complex.

I weigh less than 15kg.

Participant Groups

The trial is testing Basimglurant's ability to control seizures in TSC patients. It involves a crossover design where participants receive either Basimglurant or a placebo first and then switch to the other after a certain period.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm A (Basimglurant/NOE-101 to Placebo)Experimental Treatment1 Intervention

Basimglurant to Placebo

Group II: Arm B (Placebo to Basimglurant/NOE-101)Placebo Group1 Intervention

Placebo to Basimglurant