WE ARE CURRENTLY RECRUITING:

Our Clinical Trials Unit, a national and international benchmark in research, currently has a large number of open trials in the areas of epilepsy, Parkinson’s disease and Alzheimer’s disease.

Today we bring you a new trial in which we are already recruiting the first patients aimed at:

Patients with difficult-to-control epilepsy associated with tuberous sclerosis complex (TSC).

• Treatment of difficult-to-control epilepsy associated with tuberous sclerosis complex.

This trial seeks to evaluate the efficacy and safety of treatment with YCJ-01 by means of changes in the quantification of epileptic seizures in patients diagnosed with refractory epilepsy secondary to Tuberous Sclerosis Complex.

Patient inclusion criteria for this trial are:

1. Patients within the age range of 2 to 65 years.
2. Patients with an investigator-confirmed diagnosis of Tuberous Sclerosis Complex.
3. Refractory epilepsy secondary to Tuberous Sclerosis Complex (unresponsive to traditional antiepileptic drugs, vagus nerve stimulator, ketogenic diet, not candidates for surgery or persistent after surgery)
4. Patients with a number of seizures of four or more in the previous four weeks.
5. Stability in AED dosage and ketogenic diet/vagus nerve stimulator-associated device programming unchanged for at least 4 weeks prior to treatment initiation assigned.
6. Patients on treatment with 3 or fewer antiepileptic drugs at the time of signing the informed consent.
7. The patient and/or family/caregivers must have availability on the part of the patient or caregivers/family members to complete the seizure diary.
8. Women of childbearing age, for safety’s sake, must agree to follow the required contraceptive measures from the time of signing the informed consent until three months after stopping the investigational drug.
9. Patients who have signed the informed consent either autonomously or through a legal representative.

On the contrary, they will be grounds for exclusion:

1. Be receiving corticosteroid treatment at the time of signing the informed consent.
2. Patients who did not adhere correctly to AED treatment in the 4 weeks prior to the assigned intervention in the trial.
3. Patients who changed medication or dosage of AEDs, ketogenic diet or vagal stimulator, during the 4 weeks prior to the start of the assigned intervention in the trial.
4. Heart failure, renal, hepatic, hepatic, pancreatic or hematological dysfunction.
5. Severe uncontrolled medical condition.
6. Patients or families/caregivers (in the case of patients who are minors or under legal guardianship) who do not agree to comply with the requirements and visits of the study, or at the discretion of the treating physician present a high risk of non-compliance with the protocol.
7. Allergy to any of the components of the investigational drug/placebo.
8. Family or personal history of schizophrenia.
9. Personal history of suicide attempt. Pregnancy.
10. Breastfeeding women.
11. Have participated in another clinical trial, unless at least 5 half-lives of the investigational product or 12 weeks have elapsed if it is a cannabis oil product.
12. Patients who have received cannabis oil products in the last 12 weeks.

If you are interested in participating in this trial or have any doubts about your eligibility for inclusion, please contact our team for advice.

This trial is conducted by the Epilepsy Unit, directed by Dr. A. Gil-Nagel, and is staffed by our Clinical Trials Unit nurses.

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