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New treatment option for Tuberous Sclerosis Complex (TSC)
Official title Treatment With Full-spectrum Cannabis Extract of Refractory Epilepsy Associated With Tuberous Sclerosis Complex (TSC)
ClinicalTrials.gov ID: NCT07403266
What this study is testing
What is YCJ-01 Full Spectrum cannbis Extract?
YCJ-01 Full Spectrum cannbis Extract is an investigational medicine, given as an once-daily, being studied as a potential treatment for tuberous sclerosis complex (tsc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 1\. To assess treatment efficacy with YCJ-01 by changes in the number of epileptic seizures in patients with refractory epilepsy secondary to Tuberous Sclerosis Complex.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 65
You may be able to join if
- Patients of any sex between 2 and 65 years of age (both included) Diagnosis confirmed by the TSC investigator (by clinical criteria and/or genetic...
- Refractory epilepsy secondary to TSC, defined as that not responding successfully to traditional AEDs (2 or more), ketogenic diet, vagal nerve...
- Patients with a minimum of 4 epileptic seizures or more within 4 weeks prior to the initiation of the assigned treatment in the trial, with...
- Stability in AEDs doses, and in ketogenic diet/programming of the device associated with the vagal nerve stimulator with no changes for at least 4...
- Patients who are in treatment with 3 or less AEDs at the time of signing the informed consent. For the purposes of assessing eligibility, Clobazam...
You likely can't join if
- Patients who are receiving treatment on corticoids at the time of signing the informed consent.
- Pregnancy. Breastfeeding women To have participated in another clinical trial, unless at least 5 half- lives of the investigational product have...
- Patients who have received products with cannabis oil in the last 12 weeks. Patients who did not correctly follow the AED treatment in the 4 weeks...
- Patients who changed medication or AED dose, ketogenic diet, or the vagal stimulator during the 4 weeks prior to the initiation of the intervention...
- Cardiac, renal, and hepatic failure, pancreatic insufficiency, or hematologic dysfunction with values above the normal limits of creatinine and urea...
- Uncontrolled severe medical condition such as: hepatic disease, increased bilirubin levels more than twice the normal limit, cirrhosis, chronic...
See the full eligibility criteria
- Patients of any sex between 2 and 65 years of age (both included) Diagnosis confirmed by the TSC investigator (by clinical criteria and/or genetic study).
- Refractory epilepsy secondary to TSC, defined as that not responding successfully to traditional AEDs (2 or more), ketogenic diet, vagal nerve stimulator, and/or whose patients are not candidate for epilepsy surgery or...
- Patients with a minimum of 4 epileptic seizures or more within 4 weeks prior to the initiation of the assigned treatment in the trial, with observable external signs (loss of consciousness or motor component).
- Stability in AEDs doses, and in ketogenic diet/programming of the device associated with the vagal nerve stimulator with no changes for at least 4 weeks prior to the initiation of the assigned treatment.
- Patients who are in treatment with 3 or less AEDs at the time of signing the informed consent. For the purposes of assessing eligibility, Clobazam will not be counted as AED Willingness by patients or caregivers/family...
- In case of women of child-bearing age, for safety, those who agree to follow the required contraceptive measures from the signing of the informed consent until three months after stop the intake of the investigational...
- Patients who have signed the informed consent either by themselves or through a legal representative.
- Patients who are receiving treatment on corticoids at the time of signing the informed consent.
- Pregnancy. Breastfeeding women To have participated in another clinical trial, unless at least 5 half- lives of the investigational product have elapsed, or 12 weeks, if it is a product with cannabis oil.
- Patients who have received products with cannabis oil in the last 12 weeks. Patients who did not correctly follow the AED treatment in the 4 weeks prior to the intervention assigned in the trial.
- Patients who changed medication or AED dose, ketogenic diet, or the vagal stimulator during the 4 weeks prior to the initiation of the intervention assigned in the trial.
- Cardiac, renal, and hepatic failure, pancreatic insufficiency, or hematologic dysfunction with values above the normal limits of creatinine and urea; values 2 times the normal limits of transaminases, lipases, and serum...
- Uncontrolled severe medical condition such as: hepatic disease, increased bilirubin levels more than twice the normal limit, cirrhosis, chronic hepatitis (hepatitis B or C), uncontrolled diabetes (defined as blood...
- Patients or family/caregivers (in case of patients who are minors or under legal guardianship) who does not agree to comply with the requirements and trial visits or present a high risk of non-compliance with the...
- Allergy to any of the components of the investigational medicinal product/placebo.
- Family (considering only first-degree blood relatives) or personal history of schizophrenia.
- Personal history of suicide attempts.
The study team makes the final eligibility decision.
Where it's taking place
- Madrid, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Madrid, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.