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NCT05323734 · ClinicalTrials.gov registry record · Phase 3
Adjunctive GNX Treatment Compared With Placebo in Children and Adults With TSC-related Epilepsy
A Phase 3 study, sponsored by Marinus Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 129
- Enrollment target
NCT05323734 is a Phase 3 study that has completed, run by Marinus Pharmaceuticals. The registered enrollment target is 129 participants.
The verdict
NCT05323734, a Phase 3 study, has completed, sponsored by Marinus Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 129 participants
- Enrollment target
Study Summary
This is a Phase 3, global, double-blind, randomized, placebo-controlled study of adjunctive GNX treatment in children and adults with TSC-related epilepsy. The study consists of a 4-week prospective Baseline phase, defined as the first 28 days following screening, followed by a double-blind phase consisting of a 4-week titration period (Day 1 to Day 28) and a 12-week maintenance period (Day 29 to Week 16).
Interventions
- DRUG Placebo
- DRUG Ganaxolone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 129 participants |
| Start Date | 2022-04-01 |
| Est. Completion | 2024-10-14 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05323734
The ClinicalTrials.gov registry entry for NCT05323734 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 129 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Marinus Pharmaceuticals, which has 19 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05323734 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05323734 about?
NCT05323734 is a clinical study titled "Adjunctive GNX Treatment Compared With Placebo in Children and Adults With TSC-related Epilepsy". This is a Phase 3, global, double-blind, randomized, placebo-controlled study of adjunctive GNX treatment in children and adults with TSC-related epilepsy. The study consists of a 4-week prospective Baseline phase, defined as the first 28 days following screening, followed by a double-blind phase co...
What is the current status of trial NCT05323734?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 129 participants. The study started on 2022-04-01. Estimated completion is 2024-10-14.
What interventions are being tested in trial NCT05323734?
The interventions under investigation include: Placebo (DRUG), Ganaxolone (DRUG).
Who is sponsoring clinical trial NCT05323734?
This trial is sponsored by Marinus Pharmaceuticals, which has 19 total clinical trials registered on ClinicalTrials.gov.
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