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Effect of Valproic Acid Concentration on Photic Response

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ClinicalTrials.gov Identifier: NCT00609245
Recruitment Status : Completed
First Posted : February 6, 2008
Results First Posted : June 14, 2017
Last Update Posted : June 14, 2017
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Bassel Abou-Khalil, Vanderbilt University Medical Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Photosensitive Epilepsy
Interventions Drug: Valproic Acid
Drug: Placebo
Enrollment 13
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Valproate Infusion
Hide Arm/Group Description

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

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 Na VPA dose predictions will be based upon population VPA pharmacokinetic parameters (Dutta 2003).

Period Title: Overall Study
Started 13
Completed 12
Not Completed 1
Reason Not Completed
Adverse Event             1
Arm/Group Title Valproate Infusion
Hide Arm/Group Description

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

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 Na VPA dose predictions will be based upon population VPA pharmacokinetic parameters (Dutta 2003).

Overall Number of Baseline Participants 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
<=18 years
0
   0.0%
Between 18 and 65 years
13
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Female
10
  76.9%
Male
3
  23.1%
presence of photoparoxysmal response  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 13 participants
13
1.Primary Outcome
Title Difference in SPR During Placebo and VPA Infusions
Hide Description 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.
Time Frame At the start of EEG monitoring/drug infusion, and on an hourly basisfor 12 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
1 patient did not complete infusion of Valproic Acid due to Adverse Event. This patient was not included in final analysis.
Arm/Group Title Placebo Valproic Acid
Hide Arm/Group Description:
Each patient will have a placebo-infusion (with 0.9% NS or D5W) of 12-hour duration.
The investigators will utilize intravenous sodium valproate. Dosage will be individualized to each patient’s body weight, age, and hepatic-enzyme-inducing status. Intravenous Na VPA dose predictions will be based upon population VPA pharmacokinetic parameters (Dutta 2003).
Overall Number of Participants Analyzed 12 12
Mean (Full Range)
Unit of Measure: standard photosensitive range (SPR)
15.917
(14.739 to 17.431)
14.609
(12.903 to 17.124)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.016
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Valproic Acid Placebo
Hide Arm/Group Description 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 Na VPA dose predictions will be based upon population VPA pharmacokinetic parameters (Dutta 2003). placebo: Each patient will have a placebo-infusion (with 0.9% NS or D5W) of 12-hour duration at visit 2.
All-Cause Mortality
Valproic Acid Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Valproic Acid Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/13 (7.69%)      0/13 (0.00%)    
Skin and subcutaneous tissue disorders     
rash  1  1/13 (7.69%)  1 0/13 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Valproic Acid Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/13 (0.00%)      0/13 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Bassel Abou-Khalil, MD
Organization: Vanderbilt University Medical Center
Phone: 615-936-0060
Responsible Party: Bassel Abou-Khalil, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00609245     History of Changes
Other Study ID Numbers: IRB# 070849
First Submitted: February 1, 2008
First Posted: February 6, 2008
Results First Submitted: May 5, 2016
Results First Posted: June 14, 2017
Last Update Posted: June 14, 2017