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NCT05604170 · ClinicalTrials.gov registry record · Phase 3
Open-label Study of Adjunctive GNX Treatment in Children and Adults With TSC-related Epilepsy
A Phase 3 study, sponsored by Marinus Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 117
- Enrollment target
NCT05604170: Clinical Trial Phase 3 study, sponsored by Marinus Pharmaceuticals.
NCT05604170 is a Phase 3 study that was terminated before completion, run by Marinus Pharmaceuticals. The registered enrollment target is 117 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05604170, a Phase 3 study, was terminated before completion, sponsored by Marinus Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 117 participants
- Enrollment target
Study 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
Primary Outcome
An adverse event (AE) was any untoward medical occurrence in a clinical study patient, temporally associated with the use of study drug, whether or not considered related to the study drug. A serious adverse event was any untoward medical occurrence that, at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or any other e
Interventions
- DRUG Ganaxolone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 117 participants |
| Start Date | 2022-05-16 |
| Est. Completion | 2025-04-02 |
| Phase | Phase 3 |
Why NCT05604170 stopped before completion
NCT05604170 is an interventional study that assigns participants to a tested intervention. The registered 117 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 1 intervention - of which Ganaxolone is the first listed.
NCT05604170 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05604170 about?
NCT05604170 is a clinical study titled "Open-label Study of Adjunctive GNX Treatment in Children and Adults With TSC-related Epilepsy". 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
What is the current status of trial NCT05604170?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 117 participants. The study started on 2022-05-16. Estimated completion is 2025-04-02.
What interventions are being tested in trial NCT05604170?
The interventions under investigation include: Ganaxolone (DRUG).
Who is sponsoring clinical trial NCT05604170?
This trial is sponsored by Marinus Pharmaceuticals, which has 19 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05604170's enrollment target sits among peer trials
117 1642nd of 2000 higher than 358 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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