Basimglurant for Tuberous Sclerosis

Recruiting at 65 trial 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.

Research Team

Clinical Director, MD

Principal Investigator

Noema Pharma AG

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

For female patients of childbearing potential: Willingness to use contraception

I am willing to take pregnancy tests if I can have children.

I am between 5 and 30 years old.

Exclusion Criteria

Recent anoxic episode

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

I weigh less than 15kg.

Treatment Details

Interventions

• Basimglurant (Glutamate Receptor Antagonist)

Trial Overview 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.

Participant Groups

Group I: Arm A (Basimglurant/NOE-101 to Placebo) Experimental Treatment 1 Intervention

Basimglurant to Placebo

Group II: Arm B (Placebo to Basimglurant/NOE-101) Placebo Group 1 Intervention

Placebo to Basimglurant

Who Is Running the Clinical Trial?

Noema Pharma AG

Lead Sponsor

Trials

6

Recruited

570+