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NCT04595513 · ClinicalTrials.gov registry record · Phase 1

Stopping TSC Onset and Progression 2: Epilepsy Prevention in TSC Infants

A Phase 1 study, sponsored by Children's Hospital Medical Center, Cincinnati.

Completed
Registry status
Phase 1
Development phase
5
Enrollment target

NCT04595513 is a Phase 1 study that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 5 participants.

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The verdict

NCT04595513, a Phase 1 study, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.

COMPLETED
Registry status
Phase 1
Development phase
5 participants
Enrollment target

Study Summary

This phase I/II clinical trial is an open-label clinical trial design to verify safety and dosing for TAVT-18 (sirolimus) powder for oral solution in TSC infants (N=5).

Interventions

  • DRUG TAVT-18 (sirolimus)

Trial Details

FieldValue
Enrollment Target 5 participants
Start Date 2020-09-08
Est. Completion 2022-12-15
Phase Phase 1

What the Registry Record Tells You About NCT04595513

The ClinicalTrials.gov registry entry for NCT04595513 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 571 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which TAVT-18 (sirolimus) is the first listed.

NCT04595513 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04595513 about?

NCT04595513 is a clinical study titled "Stopping TSC Onset and Progression 2: Epilepsy Prevention in TSC Infants". This phase I/II clinical trial is an open-label clinical trial design to verify safety and dosing for TAVT-18 (sirolimus) powder for oral solution in TSC infants (N=5).

What is the current status of trial NCT04595513?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2020-09-08. Estimated completion is 2022-12-15.

What interventions are being tested in trial NCT04595513?

The interventions under investigation include: TAVT-18 (sirolimus) (DRUG).

Who is sponsoring clinical trial NCT04595513?

This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.