RecruitingPhase 3NCT05534672

Placebo Controlled Study to Assess the Efficacy and Safety of Rapamycin in Drug Resistant Epilepsy Associated With Tuberous Sclerosis Complex

Multicenter, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy and Safety of Rapamycin in Drug Resistant Epilepsy Associated With TSC


Sponsor

Katarzyna Kotulska

Enrollment

200 participants

Start Date

Jan 23, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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).


Eligibility

Min Age: 3 MonthsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether rapamycin (a drug that slows certain cell-growth signals) can reduce seizures in people with tuberous sclerosis complex (TSC) — a genetic condition that causes benign tumors to grow in the brain and other organs, often leading to hard-to-treat epilepsy. Participants will receive either rapamycin or a placebo to compare outcomes. **You may be eligible if:** - You are between 3 months and 50 years old - You have a confirmed diagnosis of TSC - You have drug-resistant epilepsy (seizures that don't respond to medications), with at least 8 seizures in the past 4 weeks - You (or your parent/caregiver) are willing and able to follow all study requirements **You may NOT be eligible if:** - You have used an mTOR inhibitor (a class of drugs similar to rapamycin) in the past 3 months - You have a history of non-epileptic (pseudo-epileptic) seizures - You have another progressive brain disease besides TSC - You had surgery or a serious infection in the past 2 weeks Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERRapamycin

Rapamycin in liquid administered orally

OTHERPlacebo

Placebo in liquid administered orally


Locations(2)

Medical University of Lodz

Lodz, Poland

Children's Memorial Health Institute, Neurology and Epileptology

Warsaw, Poland

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NCT05534672


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