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TSC-STEPSNCT05104983

Stopping TSC Onset and Progression 2B: Sirolimus TSC Epilepsy Prevention Study

StatusActive, Not Recruiting
PhasePhase 2
Primary completion (estimated)

At risk: Primary completion moved 12 months later.

See at-risk trials from Darcy Krueger

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Record History

All 12 versions: 12 with changes below. See every version on ClinicalTrials.gov ↗

  1. Enrollment closed, study ongoing
    • Trial sites reduced: 11 → 8 locations
  2. Primary completion pushed from Jun 30, 2026 to Jun 30, 2027
    • Study completion pushed from Jun 30, 2027 to Jun 30, 2028
    • Eligibility criteria expanded, about 11 words
    • Site details revised at 5 of 11 sites
  3. Primary completion date: Dec 31, 2025 to Jun 30, 2026
    • Site details revised at 11 of 11 sites
    v10
  4. Primary completion date: Jun 30, 2025 to Dec 31, 2025
    • Study sites: 9 to 11
    • Study completion date: Jun 30, 2026 to Jun 30, 2027
    v9
  5. Study sites: 8 to 9v8
Show 6 earlier versionsHide 6 earlier versions
  1. Site details revised at 2 of 8 sitesv7
  2. Site details revised at 8 of 8 sitesv6
  3. Site details revised at 1 of 8 sitesv5
  4. Site details revised at 2 of 8 sitesv4
  5. Site details revised at 1 of 8 sitesv3
  6. Collaborators shortened, about 5 wordsv2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Efficacy -- time to seizure onset
Timeframe: 12 months of age
Safety -- adverse events
Timeframe: 12 months of age

Secondary (5)

Neurodevelopmental Outcomes
Quality of Life Outcomes
EEG Biomarkers
MRI Biomarkers
Sirolimus Precision Dosing

Arms and interventions

SirolimusExperimental

Sirolimus

PlaceboPlacebo comparator

Placebo

Drugs: Sirolimus, Placebo

Sites

8 sites in 1 country