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RaRE-TSNCT05534672

Placebo Controlled Study to Assess the Efficacy and Safety of Rapamycin in Drug Resistant Epilepsy Associated With Tuberous Sclerosis Complex

StatusRecruiting
PhasePhase 3
Primary completion (estimated)

At risk: Primary completion moved at least 2 years 2 months later.

See at-risk trials from Katarzyna Kotulska

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Record History

All 3 versions: 3 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Jun 2027 to Sep 2029
    • Eligibility criteria expanded, about 14 words
    • Site details revised at 1 of 2 sites
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 2022 to Jan 23, 2023
    • Site details revised at 2 of 2 sites
    v2
  3. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

comparison of the number of patients with at least 50% reduction of seizures per week in the last month of the core blinded phase in comparison to screening phase in the rapamycin vs placebo group
Timeframe: final analyses after the formal final database lock, planned within one month after the last patient last visit in the study
number of adverse events (according to CTCAE classification) in the rapamycin vs placebo group during the double-blind core phase
Timeframe: final analyses after the formal final database lock, planned within one month after the last patient last visit in the study

Secondary (2)

comparison of the number of seizures per week and the number of days free of seizures in the rapamycin vs placebo group, during 12-week treatment in double-blind core phase
severity of adverse events (according to CTCAE) and the number of patients withdrawn from the study due to adverse events in the rapamycin vs placebo group

Arms and interventions

Rapamycin armExperimental

Each patient randomized to the rapamycin arm will receive rapamycin in liquid. The rapamycin will be administered in individually calculated doses depending on the body surface of participants

Placebo armPlacebo comparator

The patients assigned to the placebo arm will receive placebo in liquid, analogically to the rapamycin group.

Other: Rapamycin, Placebo

Sites

2 sites in 1 country