BridgeMD
Treatment of difficult-to-control epilepsy associated with tuberous sclerosis complex
EU CTIS ID: 2024-520171-27-00
What this study is 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. 2. To assess the safety of the treatment with YCJ-01 in patients with refractory epilepsy secondary to Tuberous Sclerosis Complex.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
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 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 persist with seizures after surgery.
- 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
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 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.
See the full eligibility criteria
Who can join
- 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 persist with seizures after surgery.
- 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 members (in case of patients who are minors or under legal guardianship) to complete the seizure diary.
- 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 medicinal product.
- Patients who have signed the informed consent either by themselves or through a legal representative.
What rules you out
- 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 amylase; platelets < 80000/mm3, and white blood cell count <3000/mm3.
- 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 glucose >150 mg%), (chronic or acute) active infections or uncontrolled severe infections, or active bleeding.
- 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 protocol, according to the treating physician.
- 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.
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, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.