A Study of EPX-100 (Clemizole Hydrochloride) in Participants With Dravet Syndrome

Conditions

• Dravet Syndrome

Eligibility Criteria

Sex

ALL

Age

2 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Clemizole HCl — DRUG
  Clemizole HCl will be administered as an oral solution.
• Placebo — DRUG
  Placebo will be administered as an oral solution.

Study Details

This is a multicenter, Phase 3, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of clemizole hydrochloride (EPX-100) as adjunctive therapy in children and adult participants with Dravet syndrome (DS).

Key Dates

Start date

Sep 15, 2020

Status verified

May 2026

Primary completion

Apr 30, 2027

Completion

May 31, 2029

Study Design

Enrollment

150 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Double-blind clemizole HCl
  Participants will receive their first dose of study drug following randomization.
• Placebo Comparator: Placebo
  Participants will receive their first dose of study drug following randomization.
• Experimental: Open-label clemizole HCl
  Eligible participants who complete the DB Period will have the option to continue in the OLE Period, during which they will receive clemizole HCL for up to 3 years.

Primary Outcome Measure

Percent Change in Countable Motor Seizures Per 28 Days (CMS-28) in the Titration Plus Maintenance Periods Relative to Baseline [ Time Frame: From Baseline Period (Day 1) up to 16 weeks ]

Central Contacts

• Krystle Rapchak
  +1 (312) 847-1289
  [email protected]
• Eric Bauer
  [email protected]

Locations (31)

Find similar trials in Birmingham, AL

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