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Open-label Study of Adjunctive GNX Treatment in Children and Adults With TSC-related Epilepsy

NCT05604170 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 117

Last updated 2025-10-01

Study results available
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Summary

This is a Phase 3, global, open-label extension (OLE) study of adjunctive GNX treatment in children and adults with TSC who previously participated in either Study 1042-TSC-3001 or Study 1042-TSC-2001

Conditions

  • Tuberous Sclerosis Complex

Interventions

DRUG

Ganaxolone

GNX will be administered.

Sponsors & Collaborators

  • Marinus Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-16
Primary Completion
2025-04-02
Completion
2025-04-02
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • China
  • France
  • Germany
  • Israel
  • Italy
  • Spain
  • United Kingdom

Study Locations

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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 NCT05604170 on ClinicalTrials.gov