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

Mostafa Bahaa

Status and phase: Enrolling; Phase 2

Conditions: Epilepsy

Treatments: Drug: Phenytoin; Drug: Celecoxib 200mg; Drug: Pentoxifylline 400 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT05637086

22.09.108

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 3 patient groups

Control Group

Experimental group

Description:

This group will receive 100 mg of phenytoin 3 times daily for 6 months.

Treatment:

Drug: Phenytoin

Pentoxifylline group

Active Comparator group

Description:

This group will receive 100 mg of phenytoin 3 times daily plus pentoxifylline 400 mg two times daily for 6 months

Treatment:

Drug: Pentoxifylline 400 MG

Drug: Phenytoin

Celecoxib group

Active Comparator group

Description:

This group will receive 100 mg of phenytoin 3 times daily plus celecoxib 200 mg once daily for 6 months

Treatment:

Drug: Celecoxib 200mg

Drug: Phenytoin