At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 5 enrolled
Drug / intervention
TAVT-18 (sirolimus)drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Stopping TSC Onset and Progression 2: Epilepsy Prevention in TSC Infants
Children's Hospital Medical Center, Cincinnati·interventional·Posted Oct 20, 2020·Updated May 16, 2024
In Brief
A Phase 2 clinical trial evaluating TAVT-18 (sirolimus) for Tuberous Sclerosis Complex and Epilepsy. Completed, enrolled 5 participants across 1 site.
Detailed Summary
This phase I/II clinical trial is an open-label clinical trial design to verify safety and dosing for TAVT-18 (sirolimus) powder for oral solution in TSC infants (N=5).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTuberous Sclerosis Complex, Epilepsy
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
202120222023202420252026
Enrollment StartSep 2020
First PostedOct 2020
Primary CompletionDec 2022
TodayJul 2026
First PostedOct 20, 2020
Enrollment StartSep 8, 2020
Primary CompletionDec 15, 2022
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 5.7 years ago
Interventions
TAVT-18 (sirolimus)drug
The investigational drug product to be used in this study is TAVT-18, a proprietary formulation of sirolimus in clinical development, by Tavanta Therapeutics, Inc. It is provided in a powder formulation in pre-measured vials.