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Project

GALENE (NOE-TSC-201)

Center:
Fiscal Year:
2024
Contact Information:
Project Description:
Title: GALENE (NOE-TSC-201): 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 and adolescents with uncontrolled seizures associated with Tuberous Sclerosis Complex Role: Site PI Funding: Noema Pharma 2022-present Summary: This is a prospective, cross-over, double-blind, randomized study to evaluate the efficacy and safety of basimglurant as adjunctive therapy in children and young adults with refractory epilepsy associated with Tuberous Sclerosis Complex.
Keyword(s):
Core Function(s):
Training Trainees, Performing Direct and/or Demonstration Services, Continuing Education/Community Training
Area of Emphasis
Quality Assurance, Education & Early Intervention, Child Care-Related Activities, Health-Related Activities
Target Audience:
Children/Adolescents with Disabilities/SHCN
Unserved or Under-served Populations:
Other
Primary Target Audience Geographic Descriptor:
National
Funding Source:
COVID-19 Related Data:
N/A