MedTrace Logo

Effect of Valproic Acid Concentration on Photic Response

NCT00609245 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2017-06-14

Study results available
· View outcomes & findings →

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.

Conditions

  • Photosensitive Epilepsy

Interventions

DRUG

Valproic Acid

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).

DRUG

Placebo

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

Sponsors & Collaborators

  • Abbott

    collaborator INDUSTRY

  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • Bassel Abou-Khalil, MD · Vanderbilt University

  • William Rosenfeld, MD · The Comprehensive Epilepsy Care Center for Children & Adults

  • Dorothee Kasteleijn-Nolst Trenite, MD, PhD · The Comprehensive Epilepsy Care Center for Children & Adults

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
15 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2008-12-31
Completion
2008-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00609245 on ClinicalTrials.gov