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NCT05066217 · ClinicalTrials.gov registry record · Phase 3
An Efficacy and Safety Study of Clemizole HCl in Patients With Lennox-Gastaut Syndrome
A Phase 3 study of Lennox Gastaut Syndrome, sponsored by Epygenix.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 260
- Enrollment target
- 4
- Study locations
NCT05066217 is a Phase 3 study of Lennox Gastaut Syndrome that is actively recruiting participants, run by Epygenix. The registered enrollment target is 260 participants, below the 581-participant average among 10 other Lennox Gastaut Syndrome trials with a reported enrollment target (55% lower). The trial reports 4 study locations across 4 states.
The verdict
NCT05066217, a Phase 3 study of Lennox Gastaut Syndrome, is actively recruiting participants, sponsored by Epygenix.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 260 participants
- Enrollment target
- 4
- Study locations
Study Summary
This is a multicenter, Phase 3, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of clemizole HCL (EPX-100) as adjunctive therapy in children and adult participants with Lennox-Gastaut syndrome (LGS).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Clemizole HCl
Study Locations (4)
Florida
- Rare Disease Research - Kissimmee
Minnesota
- Minnesota Epilepsy Group, P.A. - Roseville
New Jersey
- Neurology Center for Epilepsy and Seizures - Marlboro
North Carolina
- On-Site Clinical Solution - Charlotte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 260 participants |
| Start Date | 2025-04-09 |
| Est. Completion | 2029-11-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05066217
The ClinicalTrials.gov registry entry for NCT05066217 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 260 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 581-participant average among 10 other Lennox Gastaut Syndrome trials with a reported enrollment target (55% lower). The listed sponsor is Epygenix, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Lennox Gastaut Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05066217 reports 4 study locations spanning 4 distinct geographic areas - top geographies include Florida, Minnesota, New Jersey.
Frequently Asked Questions
What is clinical trial NCT05066217 about?
NCT05066217 is a clinical study titled "An Efficacy and Safety Study of Clemizole HCl in Patients With Lennox-Gastaut Syndrome". This is a multicenter, Phase 3, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of clemizole HCL (EPX-100) as adjunctive therapy in children and adult participants with Lennox-Gastaut syndrome (LGS).
What is the current status of trial NCT05066217?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 260 participants. The study started on 2025-04-09. Estimated completion is 2029-11-01.
What conditions does trial NCT05066217 study?
This clinical trial studies the following conditions: Lennox Gastaut Syndrome.
What interventions are being tested in trial NCT05066217?
The interventions under investigation include: Placebo (DRUG), Clemizole HCl (DRUG).
Who is sponsoring clinical trial NCT05066217?
This trial is sponsored by Epygenix, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05066217 being conducted?
This trial has 4 study locations across Florida, Minnesota, New Jersey, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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