An Efficacy and Safety Study of Clemizole HCl in Patients With Lennox-Gastaut Syndrome
NCT ID: NCT05066217
Last Updated: 2025-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
260 participants
INTERVENTIONAL
2025-04-09
2029-11-01
Brief Summary
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Detailed Description
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The study will consist of an Observational Period, a Double-Blind (DB) Period, and an optional Open-Label Extension (OLE) Period.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
Participants will receive their first dose of study drug following randomization.
Placebo
Placebo will be administered as an oral solution.
Double-blind clemizole HCl
Participants will receive their first dose of study drug following randomization.
Clemizole HCl
Clemizole HCl will be administered as an oral solution.
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.
Clemizole HCl
Clemizole HCl will be administered as an oral solution.
Placebo
Placebo will be administered as an oral solution.
Interventions
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Clemizole HCl
Clemizole HCl will be administered as an oral solution.
Placebo
Placebo will be administered as an oral solution.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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 motor seizure.
* History of electroencephalogram (EEG) consistent with LGS (abnormal background activity, and one of the following: 1) slow spike-wave discharges \[\<2.5 Hz\], or 2) paroxysmal fast activity during sleep).
* Abnormal cognitive development.
* Onset of seizures at 11 years of age or younger.
Exclusion Criteria
2. Known history of long QT syndrome or any significant history of a serious abnormality of the electrocardiogram (ECG) (e.g., recent myocardial infarction, clinically significant arrhythmia).
3. Family history of sudden cardiac death, unexplained death, or death from a primary dysrhythmia potentially associated with QT prolongation in any family member.
4. Seizures secondary to illicit drug or alcohol use, infection, neoplasm, demyelinating disease, degenerative neurological disease, or progressive central nervous system disease, metabolic illness, recent anoxic episode within the last 6 months requiring resuscitation, or progressive degenerative disease or any other condition, which in the opinion of the investigator, could affect seizure control.
5. Epilepsy surgery planned during the study or epilepsy surgery within 6 months prior to Screening.
6. Concomitant use of fenfluramine.
7. Prior or concomitant use of lorcaserin.
2 Years
55 Years
ALL
No
Sponsors
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Harmony Biosciences Management, Inc.
INDUSTRY
Epygenix
INDUSTRY
Responsible Party
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Principal Investigators
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Amit Ray, MD
Role: STUDY_DIRECTOR
Harmony Biosciences Management, Inc.
Locations
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Rare Disease Research
Kissimmee, Florida, United States
Minnesota Epilepsy Group, P.A.
Roseville, Minnesota, United States
Neurology Center for Epilepsy and Seizures
Marlboro, New Jersey, United States
On-Site Clinical Solution
Charlotte, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Role: primary
Role: primary
Role: primary
Other Identifiers
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EPX-100-003
Identifier Type: -
Identifier Source: org_study_id
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