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

Phase 2RecruitingNCT05637086

Mostafa Bahaa90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Epilepsy

Interventions

PhenytoinDRUG

Phenytoin remains a highly effective anti-epileptic drug, especially in generalized seizure management. Unfortunately, phenytoin efficacy on epileptic seizure is apparently reduced with its chronic use

Pentoxifylline 400 MGDRUG

Pentoxifylline (PTX) has a well validated immune modulatory and anti-inflammatory efficacy

Celecoxib 200mgDRUG

Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild to moderate pain and help relieve symptoms of arthritis

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Mansoura University

Al Mansurah, Egypt

RECRUITING

Outcomes

Primary Outcomes

The clinical outcome will be assessed through Quality of Life questionnaire (QOLIE-31)

Caregivers will complete the questionnaire for assessing the quality of life in epileptic patients.

Time frame: 6 months

Secondary Outcomes

The secondary outcome is the change in the serum level of the measured biological parameters

The secondary outcome is the change in the serum level of the measured biological parameters such as High mobility group protein B1 (HMGB-1) serum level, and Nuclear Factor Kappa B (NF-κB) serum level

Time frame: 6 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.