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

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

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 Overview

• Status: Recruiting
• Conditions: Epilepsy
• Intervention / Treatment: Drug: Phenytoin; Drug: Pentoxifylline 400 MG

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Mansoura, Egypt, 35516
    • Recruiting
    • Mansoura University
    • Contact: Maha Younis, PhD; Phone Number: 0201069491494; Email: myounis@horus.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Mostafa Bahaa
• Collaborators: Sahar El-Haggar, Prof Clinical pharmacy Department- Tanta University; Principal Investigator Maha Ahmed Younis, PhD Pharmacy Practice Department- Horus University; Tarek Mohamed Mostafa, Prof Clinical pharmacy Department- Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2022
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): November 20, 2027

Study Registration Dates

• First Submitted: November 27, 2022
• First Submitted That Met QC Criteria: November 27, 2022
• First Posted (Actual): December 5, 2022

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 17, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy, Generalized; Epilepsy; Epilepsy, Tonic-Clonic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Enzyme Inhibitors; Platelet Aggregation Inhibitors; Protective Agents; Membrane Transport Modulators; Anticonvulsants; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Cytochrome P-450 CYP1A2 Inducers; Cytochrome P-450 Enzyme Inducers; Antioxidants; Phosphodiesterase Inhibitors; Free Radical Scavengers; Radiation-Protective Agents; Pentoxifylline; Phenytoin
• Other Study ID Numbers: 22.09.108

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No