Trial Outcomes & Findings for Effect of Valproic Acid Concentration on Photic Response (NCT NCT00609245)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

13 participants

Primary outcome timeframe

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

Results posted on

2017-06-14

Participant Flow

Participant milestones

Participant milestones
Measure	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).
Overall Study STARTED	13
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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).
Overall Study Adverse Event	1

Baseline Characteristics

Effect of Valproic Acid Concentration on Photic Response

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Valproate Infusion n=13 Participants 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).
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
presence of photoparoxysmal response	13 participants n=5 Participants

PRIMARY outcome

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

Population: 1 patient did not complete infusion of Valproic Acid due to Adverse Event. This patient was not included in final analysis.

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.

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants Each patient will have a placebo-infusion (with 0.9% NS or D5W) of 12-hour duration.	Valproic Acid n=12 Participants 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).
Difference in SPR During Placebo and VPA Infusions	15.917 standard photosensitive range (SPR) Interval 14.739 to 17.431	14.609 standard photosensitive range (SPR) Interval 12.903 to 17.124

Adverse Events

Valproic Acid

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Valproic Acid n=13 participants at risk 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 n=13 participants at risk placebo: Each patient will have a placebo-infusion (with 0.9% NS or D5W) of 12-hour duration at visit 2.
Skin and subcutaneous tissue disorders rash	7.7% 1/13 • Number of events 1	0.00% 0/13

Other adverse events

Adverse event data not reported

Additional Information

Bassel Abou-Khalil, MD

Vanderbilt University Medical Center

Phone: 615-936-0060

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place