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 range18 Years

SexALL

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

What they're measuring

Neurochemical response changes to GABAergic stimulation

Timeframe: First day after placebo and first day after lovastatin intervention.

Evaluation of neuroinflammation by measuring Glutathione as a marker of oxidative stress

Timeframe: First day after placebo and first day after lovastatin intervention.

Trial details

NCT IDNCT06789497

SponsorUniversity of Coimbra

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01-01

View on ClinicalTrials.gov More Drug Resistant Epilepsy trials