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

ConditionEpilepsy

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-75

SponsorMostafa Bahaa

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

Phenytoin
Drug
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 MG
Drug
Pentoxifylline (PTX) has a well validated immune modulatory and anti-inflammatory efficacy
Celecoxib 200mg
Drug
Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild to moderate pain and help relieve symptoms of arthritis

Treatment groups

90 Participants

are divided into 3 treatment groups

Group A: Control GroupExperimental treatment 1 intervention

Group B: Pentoxifylline groupActive comparator 2 interventions

Group C: Celecoxib groupActive comparator 2 interventions

Trial 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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mostafa Bahaa

Lead sponsor

Tanta University

Sponsor institution

Tanta University

Collaborator

Principal Investigator Maha Ahmed Younis, PhD Pharmacy Practice Department- Horus University