Is NCT05219617 recruiting in Orlando, FL?

Yes, NCT05219617 is currently recruiting participants at its Orlando, FL location. This lennox gastaut syndrome clinical trial is actively enrolling qualified participants.

How do I join the lennox gastaut syndrome clinical trial in Orlando?

To join this clinical trial in Orlando, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Orlando clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Lennox Gastaut Syndrome Clinical Trial in Orlando, FL

About This Lennox Gastaut Syndrome Study in Orlando

The primary objective is to evaluate the efficacy of carisbamate (YKP509) as adjunctive treatment in reducing the number of drop seizures (tonic, atonic, and tonic-clonic) compared with placebo in pediatric and adult subjects (age 4-55 years) diagnosed with Lennox Gastaut Syndrome (LGS).

Sponsor: SK Life Science, Inc.

Who Can Participate

Inclusion Criteria

Subject must have a documented history of Lennox-Gastaut syndrome by:

Evidence of more than one type of seizure, of which at least one should be an atonic or tonic seizure

History of an electroencephalogram (EEG) reporting diagnostic criteria for LGS (abnormal background activity accompanied by slow, spike and wave pattern \<3.0 Hz)

History of developmental delay

Male or female subjects

Subjects must be age 4-55 years at the time of consent/assent

Must have been \<11 years old at the onset of LGS

Subjects must have experienced at least 2 drop seizures with potential to fall (tonic, atonic, tonic-clonic) during the 4-week Baseline period preceding randomization (minimum of 4 drop seizures in the first two weeks and 4 in the last two weeks). Drop seizures are defined as a seizure involving the entire body, trunk, or head that led or could have led to a fall, injury, slumping in a chair, or hitting the subject's head on a surface. All drop seizure types must be countable (either as isolated seizures or as countable isolated seizures in a cluster).

Subjects must have been receiving 1 to 4 concomitant anti-seizure medications (ASMs) at a stable dose for at least 4 weeks before Visit 1

If not taking Epidiolex, subjects may take other approved cannabidiol or over the counter cannabidiol products. If taking cannabidiol other than Epidiolex, consult Medical Monitor to determine if it counts as a concomitant ASM.

Dietary therapy and any CNS stimulator settings must be stable for 4 weeks prior to baseline and maintain stable regimen throughout the study. The dietary therapy and CNS stimulators are not counted as an ASM.

Parents or caregivers must be able to keep accurate seizure diaries

Subject is either not of childbearing potential, defined as premenarchal, postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), if of childbearing potential, must comply with an acceptable method of birth control during the study, for at least 4 weeks prior to study entry and for 4 weeks following completion of the study, if able.

Subject and/or caregiver(s)/legal representative must be willing and able to give informed assent/consent for participation in the study

Subject and their caregiver must be willing and able (in the investigator's opinion) to comply with all study requirements

History of COVID-19 vaccination is permitted

Exclusion Criteria

Etiology of subject's seizures is a progressive neurologic disease. Subjects with tuberous sclerosis will not be excluded from study participation, unless there is a progressive brain tumor

Evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, renal disease, hepatic disease) that in the opinion of the investigator(s) could affect the subject's safety or study conduct

Subjects who were on adrenocorticotropic hormone (ACTH) therapy in the 6 months prior to baseline

Subject on dietary therapy for less than 4 weeks prior to screening visit (Visit 1) or suffers from frequent stooling

Current use of felbamate with less than 18 months of continuous exposure

Concomitant use of vigabatrin: subjects who took vigabatrin in the past must be discontinued for at least 5 months before Visit 1 and must have documentation showing no evidence of a vigabatrin-associated clinically significant abnormality in an automated visual perimetry test, if able.

Subject who had a history of hypoxia which needed emergency resuscitation within 12 months prior to baseline

Status epilepticus within 12 weeks prior to Visit 1

Any clinically significant illness (including COVID-19) in the 4 weeks prior to Visit 1, as evaluated by the Investigator

Subject has clinically significant abnormal laboratory values, in the investigator's opinion, at Visit 1 or time of randomization (Visit 2)

Subject has a history of any serious drug-induced hypersensitivity, e.g., toxic epidermal necrolysis, or Drug Reaction with Eosinophilia and Systemic Symptoms \[DRESS\]) or any drug-related rash requiring hospitalization

Vagus Nerve Stimulation (VNS), Deep Brain Stimulation (DBS), Responsive Neurostimulator System (RNS) or other neurostimulation for epilepsy device implanted or activated \<5 months year prior to enrollment. Stimulation parameters that have been stable for \<4 weeks, or Battery life of unit not anticipated to extend for duration of trial.

Subject is pregnant, may be pregnant, lactating or planning to be pregnant

Any suicidal ideation with intent, with or without a plan within 6 months before Visit 2 (i.e., answering "Yes" to questions 4 or 5 in the Suicidal Ideation section of the age- specific Columbia-Suicide Severity Rating Scale (C-SSRS) in subjects aged 6 and above who are able to be evaluated

Any suicidal behavior within 2 years before Visit 2 (i.e., answering YES to any question in the Suicidal behavior section of the age-specific Columbia-Suicide Severity Rating Scale (C-SSRS) in subjects aged 6 and above who are able to be evaluated.

Evidence of significant active hepatic disease. Stable elevations of liver enzymes (alanine aminotransferase (ALT), and aspartate aminotransferase (AST)) due to concomitant medication(s) will be allowed if they are \<3 x ULN

Subject with total bilirubin \[TBL\] \>2 x ULN (except for Gilbert's syndrome).

Active viral hepatitis (B or C) as demonstrated by positive serology at the Screening visit (Visit 1)

History of positive antibody/antigen test for human immunodeficiency virus (HIV)

If taking Epidiolex, subject may not use other approved cannabidiol or over the counter cannabidiol products

Scheduled for epilepsy-related surgery, VNS insertion, or any other stimulators/surgery during the projected course of the study

Subject who has taken or used any investigational drug or device in the 4 weeks prior to the screening visit (Visit 1)

Concomitant use of medications known to be strong inducers of cytochrome P450 (CYP3A) including, but not limited to: phenobarbital, phenytoin, carbamazepine, primidone, rifampin, troglitazone, St. John's Wort, efavirenz, nevirapine, glucocorticoids (other than topical usage), modafinil, pioglitazone, and rifabutin

Evidence of cardiac disease, including unstable angina, myocardial infarction, within the past 2 years, uncontrolled heart failure, major arrhythmias, congenital short QT syndrome

Subject with a short QTc interval (\<340 msec) or long QTc interval (\>460 msec) as confirmed by a repeated electrocardiogram (ECG)

Benzodiazepine rescue administered on average more than once a week in the month before Visit 1

Previous exposure to carisbamate or sensitivity/allergy to components of the oral suspension.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Orlando?

Yes, this clinical trial (NCT05219617) has an active research site in Orlando, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Lennox Gastaut Syndrome Treatment Options in Orlando, FL

If you're searching for lennox gastaut syndrome treatment options in Orlando, FL, this clinical trial (NCT05219617) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Orlando research site is actively enrolling participants for this phase 3 clinical trial. You'll receive care from experienced lennox gastaut syndrome specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all lennox gastaut syndrome clinical trials near you to find additional studies recruiting in your area.

Lennox Gastaut Syndrome Clinical Trial in Orlando, FL

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