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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: Completed Phase 3 study, sponsored by Marinus Pharmaceuticals.
NCT05323734 is a Phase 3 study that has completed, run by Marinus Pharmaceuticals. The registered enrollment target is 129 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Primary seizures include atonic/drop, bilateral clonic, bilateral tonic, focal motor with altered awareness, focal motor with intact awareness, focal to bilateral tonic-clonic seizures, focal with hypotonia impaired awareness, and generalized tonic-clonic. Seizure frequency was calculated as the total number of seizures divided by the number of days with seizure data in the period, multiplied by 28. Percent change from Baseline in 28-day seizure frequency was calculated as follows for each parti
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 |
What the finished NCT05323734 record still lists
NCT05323734 is an interventional study that assigns participants to a tested intervention. The registered 129 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 (83% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05323734 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05323734's enrollment target sits among peer trials
129 1597th of 2000 higher than 400 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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