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Ganaxolone for Tuberous Sclerosis-Related Epilepsy (TrustTSC Trial)
TrustTSC Trial Summary
This trial is testing a possible new treatment for epilepsy in people with tuberous sclerosis complex. It is a Phase 3 study, which means it is one of the last stages of testing before the drug can be approved.
TrustTSC Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTrustTSC Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.TrustTSC Trial Design
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Who is running the clinical trial?
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- I am scheduled for epilepsy surgery or had surgery in the last 6 months.I am currently taking ACTH, prednisone, or strong CYP3A4 inducers.I have been diagnosed with TSC through genetic testing or clinical assessment.I have been on a stable epilepsy medication regimen for at least 28 days.I have not used traditional Chinese medicine in the last 28 days.I agree to use effective birth control methods.I do not have an active brain infection or a disease causing brain deterioration.I am between 1 and 65 years old.I've had at least 8 seizures a month in the last 2 months.I can take the study drug with food as instructed.I have been treated with GNX before.I have been taking felbamate for less than a year.I have liver, bile duct, or kidney problems.I am using CBD products that are not Epidiolex.My drug screen for CBD or THC was positive.I haven't changed my long-term medications in the last 4 weeks.I don't have any health issues that could risk my safety or affect the study's results.My seizures have not stopped despite trying 2 or more medications.
- Group 1: Placebo matching GNX
- Group 2: Ganaxalone (GNX)
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does this clinical trial target a specific age group?
"According to the specific guidelines set out by the trial, applicants who are 1 year to 65 years old are eligible. Out of the 656 total trials, 142 are for patients under 18 and 514 are for patients over 65."
Are participants being currently accepted for this research?
"The clinicaltrials.gov website lists this trial as recruiting, with an original posting date of April 1st, 2022 and a most recent update of October 28th, 2022."
How many guinea pigs are being used for this medical experiment?
"One hundred and sixty-two patients that fulfill the requirements set by the sponsor, Marinus Pharmaceuticals, are necessary to carry out this study. The trial will take place in various locations, including University of Florida Gainesville in Gainesville, Florida, and Children's Hospital of Orange County in Orange, California."
Has the FDA cleared GNX oral suspension for use three times a day?
"GNX oral suspension, TID has some clinical evidence supporting its efficacy and multiple studies backing its safety, so it received a score of 3."
Could you provide information about how many research facilities are participating in this study?
"To make things more convenient for potential participants, 67 sites are currently enrolling patients for this study. While the locations in Gainesville, Orange and Hershey are the closest, there are 67 other locations across the country."
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