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mTOR inhibitor

TAVT-18 (sirolimus) for Epilepsy (STOP2 Trial)

Phase 1 & 2
Waitlist Available
Led By Darcy Krueger, MD, PhD
Research Sponsored by Children's Hospital Medical Center, Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 and 24 months of age
Awards & highlights

STOP2 Trial Summary

This trial is to see if a drug is safe and works well in infants with a certain disease.

Eligible Conditions
  • Epilepsy
  • Tuberous Sclerosis

STOP2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 and 24 months of age
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 and 24 months of age for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy - time to seizure onset
Safety - adverse events
Secondary outcome measures
Adaptive behavior assessed by the the VABS
Age at seizure onset
Global neurodevelopment assessed by the Bayley Scales of Infant Development
+6 more

STOP2 Trial Design

1Treatment groups
Experimental Treatment
Group I: Stage 1 Open LabelExperimental Treatment1 Intervention
Phase I/II, open-label PK and initial safety analysis. TAVT-18 administered orally twice/daily to achieve precision dosing target of 10 ng/ml. Whole blood sirolimus levels are assessed at defined intervals on days 1, 7, and 14. After day 14, participants can elect to continue open-label treatment with TAVT-18 until 12 months of age. Final developmental outcomes are assessed at 24 months of age.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TAVT-18 (sirolimus)
2020
Completed Phase 2
~10

Find a Location

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor
815 Previous Clinical Trials
6,531,586 Total Patients Enrolled
13 Trials studying Epilepsy
2,340 Patients Enrolled for Epilepsy
Darcy Krueger, MD, PhDPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati
2 Previous Clinical Trials
361 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Stopping TSC Onset and Progression 2: Epilepsy Prevention in TSC Infants
2020. "Stopping TSC Onset and Progression 2: Epilepsy Prevention in TSC Infants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04595513.
~1 spots leftby Apr 2025
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