Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 3 study of Lennox Gastaut Syndrome, sponsored by Epygenix.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Percent change in CMMS-28 from the Baseline Period through the end of the DB Period
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 |
What NCT05066217 shows while recruiting
NCT05066217 is an interventional study that assigns participants to a tested intervention. The registered 260 participants enrollment target is mid-sized for trials with a published cap, below the 581-participant average among 10 other Lennox Gastaut Syndrome trials with a reported enrollment target (55% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Lennox Gastaut Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05066217's enrollment target sits among peer trials
260 3rd of 10 higher than 8 of 10 other Lennox Gastaut Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lennox Gastaut Syndrome 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
-
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
RECRUITING · Phase 3
-
A Study to Investigate the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution in Children and Adults With Epileptic Encephalopathy Including Dravet Syndrome and Lennox-Gastaut Syndrome
COMPLETED · Phase 3
-
A Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P; CBD) as Adjunctive Treatment for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults
COMPLETED · Phase 3
-
Comparative Effectiveness of Palliative Surgery Versus Additional Anti-Seizure Medications for Lennox-Gastaut Syndrome
RECRUITING
-
Assessment of Potential for Chronic Liver Injury in Participants Treated With Epidiolex (Cannabidiol) Oral Solution
ACTIVE NOT RECRUITING · Phase 4
-
RNS System LGS Feasibility Study
ACTIVE NOT RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02283996 · 260 participants · Phase 4
Adhesive Capsulitis: Prospective Analysis of Efficacy and Financial Impact for Use of Physical Therapy in Treatment
- NCT03276793 · 260 participants · NA
Brain Connectivity in Depression
- NCT03407469 · 260 participants
Measurement of Adherence and Health-Related Quality of Life, and Health-Care Resource Utilization
- NCT03713125 · 260 participants · NA
Executive Function in Early Childhood
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI