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OncoMatch/Clinical Trials/NCT04987463

Efficacy and Safety of Rapamycin Versus Vigabatrin in the Prevention of Tuberous Sclerosis Complex Symptoms in Infants

Official title: Randomized, Placebo-controlled, Double-blind and Double-dummy Clinical Trial Comparing the Safety, Tolerability, and Efficacy of Vigabatrin and Rapamycin in a Preventive Treatment of Infants With Tuberous Sclerosis Complex

Is NCT04987463 recruiting? Yes, currently enrolling (Oct 2026). This Phase 2/3 trial studies multiple treatments including Vigabatrin and Rapamycin for tuberous sclerosis complex.

Phase 2/3RecruitingKatarzyna KotulskaNCT04987463Data as of Oct 2026Location: Poland

Treatment: Vigabatrin · Rapamycin — 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).

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Extracted eligibility criteria

Treatments studied

Other

VigabatrinRapamycin

Demographics

Ages 0–0

Prior therapy

No prior treatment (treatment-naive required)

Cannot have received: antiepileptic treatment

history of antiepileptic treatment

Cannot have received: mTOR inhibitor

history of treatment with mTOR (mammalian Target of Rapamycin) inhibitor

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT04987463 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

Is there an age limit?

Yes. Patients must be 0 years or younger and at least 0 years old.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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