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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Valproate Infusion

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).


Participant Flow:   Overall Study
    Valproate Infusion
STARTED   13 
COMPLETED   12 
NOT COMPLETED   1 
Adverse Event                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Valproate Infusion

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).


Baseline Measures
   Valproate Infusion 
Overall Participants Analyzed 
[Units: Participants]
 13 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      13 100.0% 
>=65 years      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      10  76.9% 
Male      3  23.1% 
presence of photoparoxysmal response 
[Units: Participants]
 13 


  Outcome Measures

1.  Primary:   Difference in SPR During Placebo and VPA Infusions   [ Time Frame: At the start of EEG monitoring/drug infusion, and on an hourly basisfor 12 hours ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: bassel.abou-khalil@vanderbilt.edu



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