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NCT00113815 · ClinicalTrials.gov registry record · Phase 3

Topiramate as Adjunctive Therapy in Infants 1-24 Months for the Control of Partial Onset Seizures

A Phase 3 study, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..

Completed
Registry status
Phase 3
Development phase
118
Enrollment target

NCT00113815 is a Phase 3 study that has completed, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. The registered enrollment target is 118 participants.

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The verdict

NCT00113815, a Phase 3 study, has completed, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..

COMPLETED
Registry status
Phase 3
Development phase
118 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the tolerability, safety and efficacy of topiramate in infants with refractory partial onset seizures (POS).

Interventions

  • DRUG placebo
  • DRUG topiramate

Trial Details

FieldValue
Enrollment Target 118 participants
Start Date 2005-05
Est. Completion 2007-11
Phase Phase 3

What the Registry Record Tells You About NCT00113815

The ClinicalTrials.gov registry entry for NCT00113815 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 118 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johnson & Johnson Pharmaceutical Research & Development, L.L.C., which has 102 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.

NCT00113815 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00113815 about?

NCT00113815 is a clinical study titled "Topiramate as Adjunctive Therapy in Infants 1-24 Months for the Control of Partial Onset Seizures". The purpose of this study is to evaluate the tolerability, safety and efficacy of topiramate in infants with refractory partial onset seizures (POS).

What is the current status of trial NCT00113815?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 118 participants. The study started on 2005-05. Estimated completion is 2007-11.

What interventions are being tested in trial NCT00113815?

The interventions under investigation include: placebo (DRUG), topiramate (DRUG).

Who is sponsoring clinical trial NCT00113815?

This trial is sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C., which has 102 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.