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mTOR inhibitor
Stopping TSC Onset and Progression 2: Epilepsy Prevention in TSC Infants (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
No Placebo-Only Group
Summary
This trial tests a new form of sirolimus taken by mouth to help infants with Tuberous Sclerosis Complex. It aims to prevent seizures by calming an overactive pathway in their bodies. Sirolimus has been studied and used for seizure control in pediatric patients with Tuberous Sclerosis Complex (TSC).
Eligible Conditions
- Epilepsy
- Tuberous Sclerosis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 and 24 months of age
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 and 24 months of age
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Efficacy - Time to Seizure Onset
Safety - Adverse Events
Secondary study objectives
Adaptive Behavior Assessed by the the VABS
Age at Seizure Onset
Global Neurodevelopment Assessed by the Bayley Scales of Infant Development
+6 moreSide effects data
From 2022 Phase 1 & 2 trial • 5 Patients • NCT0459551380%
Hypertriglyceridemia
60%
Tussis (cough)
60%
Rhinitis
60%
Hypercholesterolemia
60%
Otitis Media
40%
Insomnia
40%
Pyrexia (fever)
40%
Rhinorrhea (Congestion)
40%
Stomatitis (mouth sores/ulcers)
40%
Constipation
40%
Excessive Flatulence
20%
Fussiness
20%
Eczema
20%
Fatigue
20%
Rash (Allergic reaction)
20%
Diarrhea
20%
Discomfort/Pain due to Teething
20%
Lip Lesion
20%
Hematochezia (Bloody stool)
20%
Dermatitis
20%
Emesis (vomiting)
20%
Rhinosinusitis (Sinus infection)
20%
Abscess w/Infection
20%
Croup w/Stridor
20%
Respiratory Syncytial Virus (RSV)
20%
Hand-Foot-Mouth Disease
20%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Stage 1 Open Label
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
839 Previous Clinical Trials
6,565,612 Total Patients Enrolled
14 Trials studying Epilepsy
2,650 Patients Enrolled for Epilepsy
Darcy Krueger, MD, PhDPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati
2 Previous Clinical Trials
371 Total Patients Enrolled