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

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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05637086

Enrollment

Registered

2022-12-05

Start date

2022-12-20

Completion date

2027-11-20

Last updated

2024-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

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.

Interventions

DRUGPhenytoin

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

DRUGPentoxifylline 400 MG

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

DRUGCelecoxib 200mg

Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild to moderate pain and help relieve symptoms of arthritis

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Masking description

double-blinded.

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026