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Placebo controlled study to assess the efficacy and safety of rapamycin in drug resistant epilepsy associated with tuberous sclerosis complex
EU CTIS ID: 2024-515937-13-00
What this study is testing
The primary objective of the RaRE-TS study is to determine safety, tolerability and efficacy of rapamycin versus placebo in a drug resistant epilepsy associated with 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
- Parents/caregivers are willing to and able to give informed consent form for the participation in the study
- Parents/caregivers are willing to and able to comply with all study requirements
- Definite diagnosis of TSC according to the Consensus criteria (Northrup, 2013)
- drug-resistant epilepsy associated with TSC with at least 8 seizures during 4 weeks
- male or female aged from 3 months up to 55 years at the day of randomization
- body weight of at least 6 kg and proper nutritional status (assessed by investigator)
You likely can't join if
- history of treatment with mTOR inhibitor in the three months prior to screening
- Allergy to peanuts or soy
- history of pseudo-epileptic seizures
- history of progressive CNS disease other than TSC
- recent surgery within 2 weeks prior to the screening
- severe infection within 2 weeks prior to the screening
See the full eligibility criteria
- Parents/caregivers are willing to and able to give informed consent form for the participation in the study
- Parents/caregivers are willing to and able to comply with all study requirements
- Definite diagnosis of TSC according to the Consensus criteria (Northrup, 2013)
- drug-resistant epilepsy associated with TSC with at least 8 seizures during 4 weeks
- male or female aged from 3 months up to 55 years at the day of randomization
- body weight of at least 6 kg and proper nutritional status (assessed by investigator)
- history of treatment with mTOR inhibitor in the three months prior to screening
- Allergy to peanuts or soy
- history of pseudo-epileptic seizures
- history of progressive CNS disease other than TSC
- recent surgery within 2 weeks prior to the screening
- severe infection within 2 weeks prior to the screening
- contraindications for MRI or general anesthesia
- occurrence of the serious comorbidities which, in the opinion of the investigator, may either put a patient at significant risk associated with the participation in the study or may influence the results of the study the investigator
- pregnancy
- hypersensitivity to the active substance or to any of the excipients of IMP / placebo
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.