Status:
COMPLETED
Clinical Trial Data Set Re-use With Statistical Methodologies Tailored for Clinical Trials in Rare Diseases
Lead Sponsor:
Imagine Institute
Collaborating Sponsors:
RWTH Aachen University
Ruhr University of Bochum
Conditions:
Tuberous Sclerosis
Epilepsy
Eligibility:
All Genders
4-2 years
Brief Summary
Tuberous sclerosis complex (TSC), affecting 1 in 6.000 live births, is characterized by the development of multisystem tumors. Seizures are frequent up to 80% of individuals. They usually start in inf...
Detailed Description
EPISTOP-IDEAL (EPISTOP clinical trial data set re-use with statistical methodologies tailored for clinical trials in rare diseases).aims to show the usability and capability of the newly developed sta...
Eligibility Criteria
Inclusion
- Patients followed from 2013 to 2021 at the reference center for rare epilepsies with a diagnosis of tuberous sclerosis of Bourneville (based on Roach criteria and/or pathogenic variant identified in TSC1 or TSC2)
- Start of follow-up at the reference center for rare epilepsies before the age of 4 months
- Absence of epileptic seizures observed by relatives or on video EEG until inclusion
Exclusion
- objection from their legal representatives
- Antiepileptic treatment before or at the time of study entry
- Seizure occurrence prior to the inclusion visit
Key Trial Info
Start Date :
July 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2023
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05199402
Start Date
July 1 2021
End Date
October 1 2023
Last Update
January 15 2025
Active Locations (1)
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1
Rima Nabbout
Paris, France, 75015