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

Study 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.

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

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Drug: Phenytoin
* Drug: Pentoxifylline 400 MG


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control Group<br>This group will receive 100 mg of phenytoin 3 times daily for 6 months. | Drug: Phenytoin<br>* 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<br>|
| Active Comparator: Pentoxifylline group<br>This group will receive 100 mg of phenytoin 3 times daily plus pentoxifylline 400 mg two times daily for 6 months | Drug: Phenytoin<br>* 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<br>Drug: Pentoxifylline 400 MG<br>* Pentoxifylline (PTX) has a well validated immune modulatory and anti-inflammatory efficacy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 months |