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

Sponsor

Mostafa Bahaa (Other)

Overall Status

Recruiting

CT.gov ID

NCT05637086

Collaborator

Sahar El-Haggar, Prof Clinical pharmacy Department- Tanta University (Other), Principal Investigator Maha Ahmed Younis, PhD Pharmacy Practice Department- Horus University (Other), Tarek Mohamed Mostafa, Prof Clinical pharmacy Department- Tanta University (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Epilepsy	Drug: Phenytoin Drug: Pentoxifylline 400 MG	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Masking Description:

double-blinded.

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Dec 20, 2022

Anticipated Primary Completion Date :

Dec 20, 2026

Anticipated Study Completion Date :

Nov 20, 2027

Arms and Interventions

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

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

Drug: Pentoxifylline 400 MG

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

Outcome Measures

Primary Outcome Measures

The clinical outcome will be assessed through Quality of Life questionnaire (QOLIE-31) [6 months]
Caregivers will complete the questionnaire for assessing the quality of life in epileptic patients.

Secondary Outcome Measures

The secondary outcome is the change in the serum level of the measured biological parameters [6 months]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mansoura University	Mansoura		Egypt	35516

Sponsors and Collaborators

Mostafa Bahaa
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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mostafa Bahaa, Teaching Assistant, Tanta University

ClinicalTrials.gov Identifier:

NCT05637086

Other Study ID Numbers:

22.09.108

First Posted:

Dec 5, 2022

Last Update Posted:

Dec 7, 2022

Last Verified:

Dec 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Epilepsy

Epilepsy, Tonic-Clonic

Phenytoin

Pentoxifylline

Study Results

No Results Posted as of Dec 7, 2022