The GABAergic Inhibitory System in Drug Resistant Epilepsy

NCT06789497 | Completed

• 2 other identifiers: CIBIT-EPILEPSY-1FLAD Life Science 2020
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Drug Resistant Epilepsy; Temporal Lobe Epilepsy

Outcome Measures

Primary Outcomes (2)

• 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.

  First day after placebo and first day after lovastatin intervention.

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

  First day after placebo and first day after lovastatin intervention.

Study Arms (2)

Lovastatin

EXPERIMENTAL

Drug: Lovastatin 60 MG

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Lovastatin 60 MG DRUG

Participants were given lovastatin 60 mg/day for three consecutive days.

Lovastatin

Placebo DRUG

Participants were given placebo 60 mg/day for three consecutive days.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of pharmacoresistant epilepsy as defined by the International League Against Epilepsy,
• focal temporal lobe onset
• nonpregnant and nonlactating in women

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Coimbra: lead

Study Sites (1)

Institute of Nuclear Sciences Applied to Health

Coimbra, Coimbra District, 3000-548, Portugal

Location

MeSH Terms

Conditions

Drug Resistant Epilepsy; Epilepsy, Temporal Lobe

Interventions

Lovastatin

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsies, Partial; Epileptic Syndromes

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Dr

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: January 23, 2025
• Study Start: January 12, 2020
• Primary Completion: January 1, 2024
• Study Completion: April 1, 2024
• Last Updated: January 23, 2025

Record last verified: 2025-01

Locations

PT (1)