CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 13 enrolled
Drug / intervention
Valproic Acid +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00609245
NCT00609245Phase 4Completed

Effect of Small Changes in Plasma Valproic Acid Concentration on the Photoparoxysmal Response

Vanderbilt University Medical Center·interventional·Posted Feb 6, 2008·Updated Jun 14, 2017

In Brief

A Phase 4 clinical trial evaluating Valproic Acid and Placebo for Photosensitive Epilepsy. Completed, enrolled 13 participants across 2 sites.

Detailed Summary

We are trying to learn if small changes in the amount of a valproate in the blood (given through an IV) will change the way the brain reacts to flashing lights.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsAbbott

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 6, 2008
Enrollment StartDec 1, 2007
Primary CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 18.4 years ago

Interventions

Valproic Aciddrug

The investigators will utilize intravenous sodium valproate at visit 3. Dosage will be individualized to each patient's body weight, age, and hepatic-enzyme-inducing status. Intravenous VPA dose predictions will be based upon population VPA pharmacokinetic parameters (Dutta 2003).

Placebodrug

Each patient will have a placebo-infusion (with 0.9% NS or D5W) of 12-hour duration at visit 2.