Study design & results
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Trial intelligence / Profile preview
PROTECT
2022-502332-39-00Phase 2Authorised
- Sponsor
- Heidelberg University Hospital
- Start
- Nov 2023
- Modality
- Small Molecules
- Countries
- 2
01
Overview
Phase 2, randomised, open-label trial in tuberous sclerosis complex (TSC) comparing Pre-emptive sirolimus + standard of care with Standard of care alone (2 arms). Primary endpoint: Neuropsychologic outcome at 24 months. Planned start Nov 2023; status: authorised.
02
Drugs
sirolimus
03
Conditions
tuberous sclerosis complex (TSC)
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Study design, results and competitive context are available in the Gosset platform where reported.
Competitive context
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