Effect of Valproic Acid Concentration on Photic Response (NCT00609245) | Clinical Trial Compass
CompletedPhase 4
Effect of Valproic Acid Concentration on Photic Response
United States13 participantsStarted 2007-12
Plain-language 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.
Who can participate
Age range
15 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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 a…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Difference in SPR During Placebo and VPA Infusions
Timeframe: At the start of EEG monitoring/drug infusion, and on an hourly basisfor 12 hours