NCT06789497

The GABAergic Inhibitory System in Drug Resistant Epilepsy

Lovastatin Modulation of the Inhibition-excitation Balance in Temporal Lobe Onset Drug Resistant Epilepsy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: University of Coimbra · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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).

Conditions

• Drug Resistant Epilepsy
• Temporal Lobe Epilepsy

Interventions

Type	Name	Description
DRUG	Lovastatin 60 MG	Participants were given lovastatin 60 mg/day for three consecutive days.
DRUG	Placebo	Participants were given placebo 60 mg/day for three consecutive days.

Timeline

• Start date: 2020-01-12
• Primary completion: 2024-01-01
• Completion: 2024-04-01
• First posted: 2025-01-23
• Last updated: 2025-01-23

Locations

1 site across 1 country: Portugal