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NCT01070316 · ClinicalTrials.gov registry record · Phase 1

Everolimus (RAD001) Therapy for Epilepsy in Patients With Tuberous Sclerosis Complex (TSC)

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

Completed
Registry status
Phase 1
Development phase
20
Enrollment target

NCT01070316: Completed Phase 1 study, sponsored by Children's Hospital Medical Center, Cincinnati.

NCT01070316 is a Phase 1 study that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01070316, a Phase 1 study, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.

COMPLETED
Registry status
Phase 1
Development phase
20 participants
Enrollment target

Study Summary

The goal of this study is to learn if the study drug RAD001 can reduced the number of epileptic seizures, and can be taken safety by people who have epilepsy associated with Tuberous Sclerosis Complex.

Primary Outcome

The primary efficacy endpoint was the percentage of participants demonstrating a 50% or greater reduction in seizure frequency at the end of the maintenance phase (weeks 13-16) compared to baseline (weeks 1-4)

Interventions

  • DRUG Everolimus

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2010-01
Est. Completion 2016-04
Phase Phase 1

What the finished NCT01070316 record still lists

NCT01070316 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).

The record links to 0 conditions, and to 1 intervention - of which Everolimus is the first listed.

NCT01070316 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01070316 about?

NCT01070316 is a clinical study titled "Everolimus (RAD001) Therapy for Epilepsy in Patients With Tuberous Sclerosis Complex (TSC)". The goal of this study is to learn if the study drug RAD001 can reduced the number of epileptic seizures, and can be taken safety by people who have epilepsy associated with Tuberous Sclerosis Complex.

What is the current status of trial NCT01070316?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2010-01. Estimated completion is 2016-04.

What interventions are being tested in trial NCT01070316?

The interventions under investigation include: Everolimus (DRUG).

Who is sponsoring clinical trial NCT01070316?

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

How this trial's enrollment target compares

Where NCT01070316's enrollment target sits among peer trials

20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01070316, the US trial registry maintained by the National Library of Medicine. NCT01070316 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.