An interventional study of Lovastatin 60 MG and Placebo in Drug Resistant Epilepsy and Temporal Lobe Epilepsy, sponsored by University of Coimbra. Completed at 1 site in Portugal. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-23.
Sponsored by University of Coimbra · Not applicable, Interventional, and Basic science
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.
This study investigates the potential therapeutic effects of lovastatin, a drug known for its anti-inflammatory and neuroprotective properties, in patients with temporal lobe drug-resistant epilepsy (DRE). Emerging evidence suggests that inflammation plays a significant role in epileptogenesis, and preclinical models of epilepsy have demonstrated the efficacy of statins in reducing seizure susceptibility.
This pilot, double-blinded, placebo-controlled crossover study included five participants with focal-onset DRE. The primary objectives were to evaluate the impact of lovastatin on cortical inhibition, oxidative stress, and seizure activity. Participants received 60 mg/day of lovastatin or placebo for a specified period, with treatment phases separated by a washout period.
Key assessments included magnetic resonance spectroscopy (MRS) to measure brain metabolites such as GABA, glutamate, and glutathione in the occipital cortex. Event-related potentials (ERP) were recorded during a facial recognition task to examine visual evoked potentials, while resting EEG was used to analyze interictal epileptiform discharges (IEDs).
1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.
This study's enrollment of 5 is below the median of 50 across 1,206 interventional studies indexed under Epilepsy.
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Exclusion Criteria:
Drug: Lovastatin 60 MG
Drug: Placebo
Participants were given lovastatin 60 mg/day for three consecutive days.
Participants were given placebo 60 mg/day for three consecutive days.
Neurochemical response changes to GABAergic stimulation
Comparing changes in brain excitation-inhibition measures (i.e., glutamate and GABA) when the GABAergic system is activated by oral dose of the Lovastatin 60mg during 3 days versus the placebo condition.
Time frame: First day after placebo and first day after lovastatin intervention.
Evaluation of neuroinflammation by measuring Glutathione as a marker of oxidative stress
Time frame: First day after placebo and first day after lovastatin intervention.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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University of Coimbra