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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05066217
Other study ID # EPX-100-003
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date May 1, 2024
Est. completion date February 1, 2025

Study information

Verified date February 2024
Source Epygenix
Contact Luis Rojas, MSc, PhD.
Phone (305) 510-4820
Email luis.rojas@epygenix.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Clemizole HCl
Double-Blind Randomized
Placebo to match EPX-100
Double-Blind Randomized

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Epygenix

Outcome

Type Measure Description Time frame Safety issue
Primary The percent change in the frequency of seizures that result in drops. 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. 4-week Observation Phase (Baseline period) and the final 4-week period of the 12-week Maintenance Phase
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