Clinical trial · Interventional
Basimglurant (NOE-101) in Children, Adolescents, and Young Adults With TSC
A Phase 2B, Multicenter, 30-week, Prospective, Cross-over, Double-blind, Randomized, Placebo-controlled Study Followed by a 52-Week Open-label Extension Study to Evaluate the Efficacy and Safety of Basimglurant Adjunctive to Ongoing Anticonvulsive Therapy in Children, Adolescents, and Young Adults With Uncontrolled Seizures Associated With Tuberous Sclerosis Complex
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The study intends to show that basimglurant (NOE-101) provides effective seizure control in children, adolescents and young adults with Tuberous Sclerosis Complex (TSC).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Tuberous Sclerosis Complex | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Basimglurant with crossover to Placebo | Drug | — | UNRESOLVED |
| Placebo with crossover to Basimglurant | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A (Basimglurant/NOE-101 to Placebo)
- description
- Basimglurant to Placebo
- interventionNames
- Drug: Basimglurant with crossover to Placebo
- type
- PLACEBO_COMPARATOR
- label
- Arm B (Placebo to Basimglurant/NOE-101)
- description
- Placebo to Basimglurant
- interventionNames
- Drug: Placebo with crossover to Basimglurant
Primary outcomes (1)
- measure
- Mean percentage in monthly seizure frequency during the maintenance dosing in Period 2 (Weeks 13 to 16) and Period 4 (Weeks 27-30).
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 5 Years
- Maximum age
- 30 Years
Show eligibility criteria text
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 30 years at study entry * A documented history of TSC * Refractory seizure history * Currently receiving one or more anti-epileptic drugs (AEDs) * Stable medications or interventions for epilepsy * Willingness to complete Patient Reported Outcome assessments * 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
References
Publications (0)
Data not yet available