Effect of Valproic Acid Concentration on Photic Response

NCT00609245 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: IRB# 070849
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

epilepsy; photosensitive; valproic acid

Outcome Measures

Primary Outcomes (1)

• Difference in SPR During Placebo and VPA Infusions

  standard photosensitive range (SPR) Each participant is exposed to intermittent photic stimulation at 14 predetermined frequencies in order to detect changes in response around typical upper and lower frequency thresholds (e.g., 2 Hz, 5 Hz, 8Hz, 10 Hz, etc.). Each flash frequency that elicits a photosensitive response is considered one "step", and the result is transformed into a metric called the standardized photosensitive range (SPR). The SPR ranges from 0 to 14, where each point represents the number of flash frequencies that elicited a photosensitive response.

  At the start of EEG monitoring/drug infusion, and on an hourly basisfor 12 hours

Study Arms (1)

Placebo then Valproic Acid (VPA)

EXPERIMENTAL

all patients will have placebo on day 1 and VPA infusion on day 2

Drug: Valproic Acid; Drug: Placebo

Interventions

Valproic Acid DRUG

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).

Also known as: Depacon

Placebo then Valproic Acid (VPA)

Placebo DRUG

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

Also known as: Normal Saline (NS) and 5% Dextrose in water (D5W)

Placebo then Valproic Acid (VPA)

Eligibility Criteria

• Age: 15 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients
• Aged 15 to 65 years
• Patients with a diagnosis of epilepsy for which they are either taking up two AEDs, not including VPA/divalproex, or no AEDs
• Patients with a reproducible IPS-induced photo-paroxysmal responses of at least 7 SPR-EEG units as measured at two different time points in the day (pm screening Study Visit 1 and am of Visit 2).
• Are in good health (with the exception of epilepsy).
• Able and willing to provide written informed consent.

You may not qualify if:

• Patients not exhibiting a photo-paroxysmal-EEG response
• Patients with active psychogenic seizures
• Women who are pregnant or lactating
• Women of reproductive potential who do not agree to use effective birth-control methods during the study and for one week after receiving study drug.
• Patients taking any dosage form of VPA/divalproex within 4 weeks prior to the study
• Patients taking more than two concomitant AEDs
• Patients with any clinically significant laboratory abnormality, which in the opinion of the investigator, will exclude the patient from the study
• Patients who are suffering from active liver disease indicated by abnormal liver function tests greater than three times the upper limit of normal (AST and ALT), patients with porphyria, or patients with a family history of severe hepatic dysfunction
• Patients with a history of alcoholism, drug abuse, or drug addiction (within the past 12 months)
• Patients with a history of sensitivity or allergic reaction to valproate / divalproex
• Patients who have a medical history which would contraindicate sodium valproate (VPA) administration
• Patients who have participated in any other trials involving an investigational product or device within 30 days of screening.
• Patients with clinically significant ECG abnormalities, as judged by the PI, at screening visit
• Patients with such poor intravenous access that the insertion of two intravenous catheters (one for sodium valproate infusion and one, in a contralateral arm vein, for serial blood sampling) for a 12-hour period is not possible.
• Patients who received benzodiazepines within one week of study initiation

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• Abbott: collaborator

Study Sites (2)

The Comprehensive Epilepsy Care Center for Children & Adults

Chesterfield, Missouri, 63017, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Epilepsy, Reflex; Epilepsy

Interventions

Valproic Acid; Saline Solution; Glucose; Water

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Hexoses; Monosaccharides; Sugars; Carbohydrates; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Results Point of Contact

• Title: Bassel Abou-Khalil, MD
• Organization: Vanderbilt University Medical Center

bassel.abou-khalil@vanderbilt.edu

615-936-0060

Study Officials

• Bassel Abou-Khalil, MD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

• William Rosenfeld, MD

  The Comprehensive Epilepsy Care Center for Children & Adults

  PRINCIPAL INVESTIGATOR

• Dorothee Kasteleijn-Nolst Trenite, MD, PhD

  The Comprehensive Epilepsy Care Center for Children & Adults

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 1, 2008
• First Posted: February 6, 2008
• Study Start: December 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: June 14, 2017
• Results First Posted: June 14, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)