Clinical Trials Logo

Clinical Trial Summary

EPX-100 (Clemizole Hydrochloride) as Adjunctive Therapy in Children With Lennox Gastaut Syndrome. (LGS)

Clinical Trial Description

To evaluate the efficacy of EPX-100 orally in divided doses as adjunctive therapy compared with placebo as measured by percent change in the frequency of seizures that result in drops in participants with Lennox-Gastaut Syndrome between the 4-week Observation Phase (Baseline period) and the final 4-week period of the 12-week Maintenance Phase. The 20 week study to include a 4-week Observation Phase (baseline) prior to initiation of study treatment, 4-week Titration Phase, and 12-week Maintenance Phase. At the option of the participant, he/she can continue oral administration of EPX-100 in an Open-Label Extension (OLE) Phase for another 52 weeks after the end of the Maintenance Phase. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05066217
Study type Interventional
Source Epygenix
Status Not yet recruiting
Phase Phase 2
Start date February 1, 2022
Completion date July 1, 2023

See also
  Status Clinical Trial Phase
Withdrawn NCT02910297 - The Pharmacokinetics of Cannabidiol (CBD) and Its Effects in Children With Severe Epilepsy
Active, not recruiting NCT03355209 - A Study to Investigate the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) as an Adjunctive Therapy in Children and Adults With Lennox-Gastaut Syndrome Phase 3
Recruiting NCT04062981 - Carisbamate Safety Study in Adult and Pediatric Subjects With Lennox-Gastaut Syndrome Phase 1
Recruiting NCT04611438 - Research on Cognitive Effect of Cannabidiol on Dravet Syndrome and Lennox-Gastaut SyndromeGastaut Syndrome Phase 3
Recruiting NCT03955432 - Long-term Cardiac Monitoring in Epilepsy N/A
Completed NCT02224560 - Efficacy and Safety of GWP42003-P for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults Phase 3
Recruiting NCT05044819 - Assessment of Potential for Chronic Liver Injury in Participants Treated With Epidiolex (Cannabidiol) Oral Solution Phase 4
Active, not recruiting NCT02655198 - Add-on Therapy With Low Dose Fenfluramine in Lennox Gastaut Epilepsy Phase 2
Completed NCT03467113 - A Study to Assess the Safety and Tolerability of ZX008 in Children and Young Adults With Dravet Syndrome or Lennox Gastaut Syndrome Currently Taking Cannabidiol Phase 1/Phase 2
Recruiting NCT03731715 - Carisbamate in Adult & Pediatric Subjects With Lennox-Gastaut Syndrome Phase 1
Enrolling by invitation NCT03936777 - 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 Phase 3
Available NCT03778424 - An Extended Access Program (EAP) for Participants Who Have Completed Rufinamide Study E2080-G000-303
Available NCT02307578 - An Extended Access Program (EAP) for Perampanel