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Research summary · AI summary · not yet reviewedHuman studyPhase 2Trial registry
Human Study on Sirolimus for Seizure Prevention in TSC Infants
This Phase II trial is designed to assess sirolimus in preventing or delaying seizure onset in infants with Tuberous Sclerosis Complex (TSC). The study is randomized, double-blind, and placebo-controlled but no results are currently available.
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This plain-English summary was written by AI from a published abstract and may contain errors. It is not medical advice. Read the original study and talk to your MS team before making decisions about treatment.
Why it matters
The study's design allows for evaluating sirolimus's efficacy and safety, which could provide insights into a potential therapeutic intervention for TSC infants at risk of seizures.
What this does not prove
No results are posted from the study, meaning conclusions cannot be drawn about the drug's efficacy or safety.
Next milestone
No next milestone was established from the available source.
Study facts
- Study design
- Interventional
- Participants / samples
- Not reported
- 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
- Yes
- Research areas
- Not classified
Original sources
Supporting passages (10)
study phaseThis trial is a Phase II randomized, double-blind, placebo controlled multi-site study to evaluate the safety and efficacy of early sirolimus to prevent or delay seizure onset in TSC infants.
study design"briefSummary": "This trial is a Phase II randomized, double-blind, placebo controlled multi-site study to evaluate the safety and efficacy of early sirolimus to prevent or delay seizure onset in TSC infants.\n\nThis study is supported by research funding from the Office of Orphan Products Division (OOPD) of the US Food and Drug Administration (FDA).",
subjectsThis trial will employ a randomized, double-blind, placebo-controlled multisite design to evaluate the safety and efficacy of early sirolimus treatment to prevent or delay seizure onset in TSC infants.
randomized"interventionModelDescription": "This trial will employ a randomized, double-blind, placebo-controlled multisite design to evaluate the safety and efficacy of early sirolimus treatment to prevent or delay seizure onset in TSC infants.",
controlled"interventionModelDescription": "This trial will employ a randomized, double-blind, placebo-controlled multisite design to evaluate the safety and efficacy of early sirolimus treatment to prevent or delay seizure onset in TSC infants.",
regulatory approvalThis study is supported by research funding from the Office of Orphan Products Division (OOPD) of the US Food and Drug Administration (FDA).
interventionThe investigational drug product to be used in this study is sirolimus, provided in oral suspension.
primary endpoint"description": "Time to seizure onset, comparing sirolimus with placebo",
findingsThis trial is a Phase II randomized, double-blind, placebo controlled multi-site study to evaluate the safety and efficacy of early sirolimus to prevent or delay seizure onset in TSC infants.
limitationsNo results are posted. Planned enrolment and endpoints are not findings.
AI assessment, not yet reviewed by a person · version 1 · Community votes are separate from evidence review.