The GABAergic Inhibitory System in Drug Resistant Epilepsy (NCT06789497) | Clinical Trial Compass
CompletedNot Applicable
The GABAergic Inhibitory System in Drug Resistant Epilepsy
Portugal5 participantsStarted 2020-01-12
Plain-language summary
This study aims to investigate the effect of lovastatin on neurotransmission and neuroinflammation in patients with temporal lobe onset drug resistant epilepsy.
Structure: (1) Visit 1: 3 consecutive days of physiologically probing drug/placebo intake, (2) Visit 2: Outcome measures and additional evaluations in the day after the last drug/placebo intake, (3) Washout period of 4 weeks, (4) 3 consecutive days of drug/placebo intake, (5) Visit 3: Outcome measures and additional evaluations in the day after the last placebo/drug intake.
Who can participate
Age range
18 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:
* diagnosis of pharmacoresistant epilepsy as defined by the International League Against Epilepsy,
* focal temporal lobe onset
* nonpregnant and nonlactating in women
Exclusion Criteria:
* history of cardiovascular or cerebrovascular disease,
* history of dyslipidemia, previous use of statins or a previously documented adverse reaction to statins,
* having any metal inside the head but outside the mouth,
* implanted devices such as cardiac pacemakers or cochlear implants,
* having a vagal nerve stimulation device and the presence of other comorbid neurologic conditions
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
Neurochemical response changes to GABAergic stimulation
Timeframe: First day after placebo and first day after lovastatin intervention.
2
Evaluation of neuroinflammation by measuring Glutathione as a marker of oxidative stress
Timeframe: First day after placebo and first day after lovastatin intervention.