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

Phase 2

Recruiting

• Conditions: Epilepsy
• Interventions: Drug: Phenytoin; Drug: Celecoxib 200mg; Drug: Pentoxifylline 400 MG

• Registration Number: NCT05637086
• Lead Sponsor: Mostafa Bahaa

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-27
• Study First Submitted QC: 2022-11-27
• Study First Posted: 2022-12-05
• Study Start: 2022-12-20
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-16
• Last Update Posted: 2024-07-18
• Primary Completion: 2026-12-20
• Study Completion: 2027-11-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Celecoxib group	Celecoxib 200mg	This group will receive 100 mg of phenytoin 3 times daily plus celecoxib 200 mg once daily for 6 months
Pentoxifylline group	Pentoxifylline 400 MG	This group will receive 100 mg of phenytoin 3 times daily plus pentoxifylline 400 mg two times daily for 6 months
Control Group	Phenytoin	This group will receive 100 mg of phenytoin 3 times daily for 6 months.
Pentoxifylline group	Phenytoin	This group will receive 100 mg of phenytoin 3 times daily plus pentoxifylline 400 mg two times daily for 6 months
Celecoxib group	Phenytoin	This group will receive 100 mg of phenytoin 3 times daily plus celecoxib 200 mg once daily for 6 months

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Mansoura University; 🇪🇬 Mansoura, Egypt