MedTrace Logo

Basimglurant (NOE-101) in Children, Adolescents, and Young Adults With TSC

NCT05059327 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2025-06-04

No results posted yet for this study

Summary

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

  • Tuberous Sclerosis Complex

Interventions

DRUG

Basimglurant with crossover to Placebo

Basimglurant with crossover to Placebo

DRUG

Placebo with crossover to Basimglurant

Placebo with crossover to Basimglurant

Sponsors & Collaborators

  • Noema Pharma AG

    lead INDUSTRY

Principal Investigators

  • Clinical Director, MD · Noema Pharma AG

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
5 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-03
Primary Completion
2025-02-06
Completion
2025-04-28
FDA Drug
Yes

Countries

  • United States
  • India
  • Israel
  • Italy
  • Poland
  • Spain
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05059327 on ClinicalTrials.gov