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Clemizole

Phase 3

Lennox Gastaut Syndrome | Small molecule | Neurology |Harmony Biosciences Holdings, Inc.|Last Updated: Apr 15, 2026

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment260
FDA Designations
No designations recorded
Clinical trial landscape

Clemizole · 2 trials · 2 indications

Phase 3 2
NCT05066217An Efficacy and Safety Study of Clemizole HCl in Patients With Lennox-Gastaut SyndromeLennox Gastaut Syndrome
RECRUITING260 Analytics
NCT04462770A Study of EPX-100 (Clemizole Hydrochloride) in Participants With Dravet SyndromeDravet Syndrome
RECRUITING150 Analytics
PHASE3RECRUITING
An Efficacy and Safety Study of Clemizole HCl in Patients With Lennox-Gastaut Syndrome
Lennox Gastaut Syndrome
NCT05066217260
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PHASE3RECRUITING
A Study of EPX-100 (Clemizole Hydrochloride) in Participants With Dravet Syndrome
Dravet Syndrome
NCT04462770150
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Study Endpoints
Primary Endpoints
Percent Change in CMMS-28
From Baseline Period up to 16 weeks

Percent change in CMMS-28 from the Baseline Period through the end of the DB Period

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

Percent change in CMS-28 from the Baseline Period through the end of the DB period.

European Union: Percent Change in Countable Motor Seizures Per 28 Days in the Maintenance Period Relative to Baseline
From maintenance period Baseline (Day 29) up to Day 85

Percent change in CMS-28 from the Baseline Period through the end of the maintenance period.

Secondary Endpoints
Proportion of Participants with ≥50% Reduction in CMMS-28
From Baseline Period up to 16 weeks
Percent Change in CMMS-28 Seizure-free Days
From Baseline Period up to 16 weeks
Clinical Global Impression of Change (CGI-C) Score
Week 16
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PlaceboPLACEBO_COMPARATORParticipants will receive their first dose of study drug following randomization.
Double-blind clemizole HClEXPERIMENTALParticipants will receive their first dose of study drug following randomization.
Open-label clemizole HClEXPERIMENTALEligible 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.
Interventions
NameTypeDescription
Clemizole HClDRUGClemizole HCl will be administered as an oral solution.
PlaceboDRUGPlacebo will be administered as an oral solution.
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Eligibility Criteria
Age Range2 Years to 55 Years
SexALL
Healthy VolunteersNo
Study Sites20

Key Inclusion Criteria: 1. Males or females, ages ≥2 to ≤55 years, at the time of Screening. 2. Participant/parent/legal authorized representative (LAR) willing and able to give written informed consent/assent. 3. Diagnosis of LGS, including: * Evidence of at least one type of countable major m...

Countries:United StatesCanadaGeorgiaHungaryPolandRomaniaSpainUnited Kingdom
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT04462770studyFirstPostDate: changed
LOWMay 24, 2026NCT05066217studyFirstPostDate: changed