CTRI/2023/04/051812Not yet recruitingPhase 2
A 20-Week Multicenter, Randomized, Double-Blind, Placebo Controlled Trial of EPX-100 (Clemizole Hydrochloride) as Adjunctive Therapy in Children and Adult Participants withDravet Syndrome (ARGUS Trial)
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Epygenix Therapeutics, Inc
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •Male and female participants 2 years and older at time of consent.
- •2. Participant or parent/Legally Authorized Representative (LAR) willing and able to provide
- •written informed consent, assent (if applicable) prior to initiation of any study related
- •procedures.
- •3. Clinical diagnosis of Dravet Syndrome. Participants must have seizures which are not
- •completely controlled by AEDs with the following criteria:
- •Onset of seizures prior to 18 months of age,
- •Normal development at onset,
- •History of seizures that are generalized, unilateral clonic, and/or hemiclonic,
- •Brain MRI without cortical malformation (not including mild atrophy associated with the
- •natural progression of Dravet Syndrome), and
- •Genetic mutation of the SCN1A gene must be documented.
- •4. The participant must be approved to participate by the Independent Reviewer, in
- •collaboration with the PI. Participants will be approved for participation following review of
- •the participantâ??s medical and seizure history, historical neuroimaging, historical EEGs,
- •genetic report confirming SCN1A mutation, and review and classification of at least 28 days
- •of baseline seizures.
- •5. >=4 countable convulsive seizures within minimum 28-day screening/baseline period (e.g.,
- •hemiclonic, secondarily generalized tonic-clonic, generalized tonic-clonic, tonic, clonic,
- •tonic/atonic (resulting in a drop), or focal with clear observable motor signs).
- •6. Participants should be on a stable regimen of AEDs >=30 days prior to Visit 1 and generally
- •in good health.
- •7. Participant or parent/ LAR is able and willing to maintain an accurate and complete daily
- •seizure and medication diary for the duration of the trial.
- •8. Sexually active women of child-bearing potential (WCBP) must be using a medically
- •acceptable method of birth control and have a negative serum or urine pregnancy test at the
- •screening (Visit 1) and Randomization (Visit 2). A WCBP is defined as a female who is
- •biologically capable of becoming pregnant. A medically acceptable method of birth control
- •includes intrauterine devices in place for at least 3 months, surgical sterilization, or adequate
- •barrier methods (e.g., diaphragm and foam). Use of oral contraceptives in combination with
- •another method (e.g., a spermicidal cream) is acceptable. In participants who are not sexually
- •active, abstinence is an acceptable form of birth control and urine will be tested per protocol.
- •Women who are of nonchild-bearing potential, i.e., post-menopause, must have this
- •condition captured in their medical history. Pregnant women are excluded from this study
Exclusion Criteria
- •Known sensitivity, allergy, or previous exposure to EPX-100 (Clemizole HCl).
- •2. Exposure to any investigational drug or device <90 days prior to screening or plans to
- •participate in another drug or device trial at any time during the study.
- •3. Seizures secondary to illicit drug or alcohol use, infection, neoplasm, demyelinating disease,
- •degenerative neurological disease, or CNS disease deemed progressive, metabolic illness, or
- •progressive degenerative disease.
- •4. Concurrent use of drugs known to interfere with EPX-100, including moderate or severe
- •inducers or inhibitors of CYP3A4/5/7. Specifically, concurrent use of carbamazepine,
- •oxcarbazepine, and/or phenytoin, as well as refraining from grapefruits and grapefruit juice
- •during the study period. A list of CYP3A4/5/7 inhibitors and inducers is included in
- •Appendix 1.
- •5. Prior or concurrent use of or lorcaserin.
- •6. Concurrent use of fenfluramine. Participants with prior use of fenfluramine within the
- •previous 3 months, or without proper documentation of an echocardiogram, at minimum 3
- •months following the last dose of fenfluramine, to ensure that the participant does not meet
- •any criteria for drug-related (fenfluramine) valvular heart disease and/or drug-related
- •pulmonary arterial hypertension (PAH) as indicated by any of the following:
- •documented mild or greater aortic regurgitation [AR] or moderate or greater mitral
- •regurgitation [MR]
- •significant (greater than mild) tricuspid regurgitation
- •abnormally thickened cardiac valve and/or has restricted motion of the valve leaflets
- •elevated right heart/pulmonary artery pressure >35mmHg
- •7. Has any medical condition that, in the PIâ??s judgment, is considered to be clinically significant
- •and could potentially affect participant safety or study outcome, including but not limited to:
- •clinically significant cardiac disease (including angina, congestive heart failure, uncontrolled
- •hypertension, and history of arrhythmias), renal, pulmonary, gastrointestinal, hematologic or
- •hepatic conditions; or a condition that affects the absorption, distribution, metabolism, or
- •excretion of drugs.
- •8. Has an active suicidal plan/intent or have had active suicidal thoughts in the past 6 months
- •or a suicide attempt in the past 3 years.
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