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Basimglurant in children, adolescents, and young adults with TSC
EU CTIS ID: 2024-512611-53-00
What this study is testing
To evaluate the efficacy of a double-blind, daily basimglurant administration, adjunctive to ongoing anticonvulsive therapy compared with placebo adjunctive to ongoing anticonvulsive therapy in patients with Tuberous Sclerosis Complex (TSC).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1) Ability and willingness to provide informed assent or written consent or consent from their legal representative. 2) Fluency in the language of the study staff 3) Age 5 to 30 years at study entry 4) A documented history of TSC 5) Refractory seizure history 6) Currently receiving one or more anti-epileptic drugs (AEDs) 7) Stable medications or interventions for epilepsy for 30 days before study entry 7) Willingness to complete Patient Reported Outcome assessments 8) 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.
You likely can't join if
- 1) Neurologic disease other than TSC 2) Recent anoxic episode 3) Patient weight below 15kg 4) Clinically significant unstable medical condition(s) 5) Pregnancy or lactation
The study team makes the final eligibility decision.
Where it's taking place
- Turkey
- India
- United Kingdom
- Israel
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Turkey; India; United Kingdom; Israel; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.