Clinical Study Evaluating and Comparing the Safety and the Possible Efficacy of Pentoxifylline and Celecoxib in Patients With Grand-Mal Epilepsy Treated by Phenytoin Monotherapy

Mostafa Bahaa1 site in 1 country90 target enrollmentDecember 20, 2022

ConditionsEpilepsy

InterventionsPhenytoin Pentoxifylline 400 MG Celecoxib 200mg

Overview

Phase: Phase 2
Intervention: Phenytoin
Conditions: Epilepsy
Sponsor: Mostafa Bahaa
Enrollment: 90
Locations: 1
Primary Endpoint: The clinical outcome will be assessed through Quality of Life questionnaire (QOLIE-31)
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Epilepsy is a chronic neurological disorder affecting millions of people all over the world. Epileptic seizures are caused by abnormal synchronized electrical neuronal discharges that could be either focal or widespread. Pathogenesis of epilepsy involves multiple processes including genetics, oxidative stress, ion channels, neuroinflammation, and cellular damage through autophagy and apoptosis.

Neuroinflammation is considered one of the most important factors contributing critically to epileptogenesis.

Registry

clinicaltrials.gov

Start Date

December 20, 2022

End Date

November 20, 2027

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Mostafa Bahaa

Responsible Party

Sponsor Investigator

Principal Investigator

Mostafa Bahaa

Teaching Assistant

Tanta University

Eligibility Criteria

Inclusion Criteria

•Patients aged ≥ 18 years old. Patients with grand mal epilepsy on phenytoin monotherapy. Women with a negative pregnancy test and women on effective contraception

Exclusion Criteria

•Patients with significant liver and kidney function abnormalities. Alcohol and/or drug abusers. Patients with known allergies to the study medications Patients with known allergy to sulfonamides (cross hypersensitivity with celecoxib).
•Pregnant women and women with a planned pregnancy. Subjects on medication are known to have possible positive effects on epilepsy. Patients who are currently using other antiepileptic drugs. Patients with CVD and a history of coronary artery bypass graft (CABG) surgery. Patients on aspirin or fluconazole therapy Patients with a recent retinal or cerebral hemorrhage