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

Epilepsy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05637086
• Other study ID #: 22.09.108
• Status: Recruiting
• Phase: Phase 2
• Start date: December 20, 2022
• Est. completion date: November 20, 2027

Study information

• Verified date: February 2024
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 20, 2027
• Est. primary completion date: December 20, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy
• Epilepsy, Tonic-Clonic

Intervention

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
• Pentoxifylline 400 MG
Pentoxifylline (PTX) has a well validated immune modulatory and anti-inflammatory efficacy

Locations

Country	Name	City	State
Egypt	Mansoura University	Mansoura

Sponsors (4)

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

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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-?B) serum level	6 months