Actively Recruiting
Placebo Controlled Study to Assess the Efficacy and Safety of Rapamycin in Drug Resistant Epilepsy Associated With Tuberous Sclerosis Complex
Led by Katarzyna Kotulska · Updated on 2023-08-08
200
Participants Needed
2
Research Sites
227 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose 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 (TSC).
CONDITIONS
Official Title
Placebo Controlled Study to Assess the Efficacy and Safety of Rapamycin in Drug Resistant Epilepsy Associated With Tuberous Sclerosis Complex
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged from 3 months up to 50 years at the day of randomization
- Patients, parents, or caregivers willing and able to provide informed consent
- Patients, parents, or caregivers willing and able to follow all study requirements
- Definite diagnosis of tuberous sclerosis complex according to Consensus criteria (Northrup, 2013)
- Drug-resistant epilepsy associated with TSC with at least 8 seizures during 4 weeks
You will not qualify if you...
- Treatment with mTOR inhibitor within 3 months prior to screening
- History of pseudo-epileptic seizures
- History of progressive central nervous system disease other than TSC
- Surgery within 2 weeks prior to screening
- Severe infection within 2 weeks prior to screening
- Use of cannabis derivatives
- Contraindications for MRI or general anesthesia
- Serious comorbidities that pose significant risk or may affect study results as judged by the investigator
- Pregnancy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Medical University of Lodz
Lodz, Poland, 90-419
Not Yet Recruiting
2
Children's Memorial Health Institute, Neurology and Epileptology
Warsaw, Poland, 04-730
Actively Recruiting
Research Team
K
Katarzyna Kotulska-Jozwiak
CONTACT
M
Monika Szkop
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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