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Research summary · AI summary · not yet reviewedHuman studyPhase 2/3Trial registry record – peer review not applicable
Phase 2/3 Study in Infants with Tuberous Sclerosis Complex
An interventional study planned to enroll 60 infants with Tuberous Sclerosis Complex (TSC) to evaluate vigabatrin and rapamycin against placebo, focusing on seizures and tumor volume over 730 days. No results have been posted, and primary endpoints include seizure occurrence and tumor measurements.
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This plain-English summary was written by AI from a trial registry record and may contain errors. It is not medical advice. Read the original study and talk to your MS team before making decisions about treatment.
- Human efficacy
- Not established from this source
- Mechanism
- Not reported
- Evidence strength
- No results yet
- Outcome
- Ongoing – no results yet
Why it matters
This study aims to clarify the effectiveness of the treatments in preventing seizures and tumor growth in infants with TSC, a condition that can cause severe neurological issues.
What this does not prove
No results are posted, and endpoints do not provide findings.
Next milestone
No next milestone was established from the available source.
Study facts
- Study design
- Interventional
- Participants / samples
- 60 · planned enrolment
- Randomised
- Yes
- Controlled
- Yes
- Primary endpoint met
- Not reported
- Relevant MS type
- Not reported
- Publication date
- Not reported
- Evidence reviewed
- Trial registry record
- Regulatory approval
- Not reported
- Research areas
- Not classified
- Biological target
- Not reported
- Pathway
- Not reported
- Population
- Infants with Tuberous Sclerosis Complex, ages from 4 Weeks to 16 Weeks
- Size of effect
- Not reported
- Secondary endpoints
- Not reported
- MRI endpoints
- Not reported
- Biomarkers
- Not reported
- Safety
- Not reported
Original sources
Supporting passages (16)
study designStudy type: Interventional
subjectsParticipants: people; ages from 4 Weeks to 16 Weeks; sex All
sample sizeEnrollment: 60 participants (estimated)
randomizedAllocation: Randomized
controlledArm types: Experimental; Experimental
peer reviewedTrial registry record.
population"briefSummary": "The purpose of the study is to evaluate the efficacy, tolerability, and safety of vigabatrin versus rapamycin as a preventive treatment in infants with Tuberous Sclerosis Complex (TSC).",
outcomeNo results are posted.
limitationsNo results are posted. Planned enrolment and endpoints are not findings.
findingsTrial registry record. Publication date: unknown. No results are posted. Planned enrolment and endpoints are not findings.
study phasePhase: Phase 2, Phase 3
controlledIntervention model: Parallel Arm types: Experimental; Experimental
primary endpointPrimary endpoints: Occurrence of clinical seizures in the blinded phase of the study,; Summarized volume of TSC-associated tumors ≥ 125% of initial value within the blinded phase of the study
interventionInterventions: Vigabatrin; Rapamycin; Placebo
follow upFollow-up: 730 days; 6, 12, 18, 24 months
sample size basisEnrollment: 60 participants (estimated)
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