Open-label Study of Adjunctive GNX Treatment in Children and Adults With TSC-related Epilepsy
Public ClinicalTrials.gov record NCT05604170. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Open-label Study of Adjunctive Ganaxolone (GNX) Treatment in Children and Adults With Tuberous Sclerosis Complex (TSC)-Related Epilepsy (TrustTSC OLE)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT05604170
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 117 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 1 Year to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 16, 2022 (Actual)
- Primary completion
- Apr 2, 2025 (Actual)
- Completion
- Apr 2, 2025 (Actual)
- Last update posted
- Oct 1, 2025
2022 – 2025
United States locations
- U.S. sites
- 20
- U.S. states
- 14
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arkansas Children's Research Institute | Little Rock | Arkansas | 72202 | — |
| UCLA Mattel Children's Hospital, TSC Center | Los Angeles | California | 90095 | — |
| Children's Hospital of Orange County | Orange | California | 92868 | — |
| Rady Children's Hospital - San Diego | San Diego | California | 92123 | — |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | — |
| Nemours Children's Hospital - Delaware Valley | Wilmington | Delaware | 19803 | — |
| Boston Children's Hospital, Harvard Medical School | Boston | Massachusetts | 02115 | — |
| Mayo Clinic - Rochester | Rochester | Minnesota | 55905 | — |
| Children's Mercy Hospital | Kansas City | Missouri | 64108 | — |
| University of Rochester Medical Center | Rochester | New York | 14642 | — |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | — |
| Atrium Health/Levine Children's Hospital | Charlotte | North Carolina | 28207 | — |
| Duke University Medical Center | Durham | North Carolina | 27712 | — |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | — |
| Le Bonheur Children's Hospital | Memphis | Tennessee | 38103 | — |
| Child Neurology Consultants of Austin (CNCA) | Austin | Texas | 78757 | — |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75207 | — |
| McGovern Medical School at the University of Texas Health Science Center | Houston | Texas | 77030 | — |
| University of Utah Health Care-Pediatric Neurology | Salt Lake City | Utah | 84108 | — |
| Seattle Children's Hospital | Seattle | Washington | 98105 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 34 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05604170, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 1, 2025 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05604170 live on ClinicalTrials.gov.