Clinical Study Evaluating Safety of Pentoxifylline and Celecoxib in Patients With Grand-Mal Epilepsy Treated by Phenytoin Monotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Phenytoin, Pentoxifylline 400 MG, Celecoxib 200mg.
- Who it may be relevant to
- Registry conditions: Epilepsy. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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
- 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 - Drug Celecoxib 200mg
Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild to moderate pain and help relieve symptoms of arthritis
Primary outcome measures
- The clinical outcome will be assessed through Quality of Life questionnaire (QOLIE-31) [Time frame: 6 months]
Secondary outcome measures (1)
- The secondary outcome is the change in the serum level of the measured biological parameters [Time frame: 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Mansoura University — Al Mansurah
Publications
- Younis MA, El-Haggar SM, Mustafa W, Mostafa TM. Pentoxifylline as Adjuvant Therapy in Patients with Generalized Epilepsy Treated with Phenytoin: A Randomized Controlled Study. Mol Neurobiol. 2025 Dec;62(12):15978-15987. doi: 10.1007/s12035-025-05214-8. Epub 2025 Jul 30. PMID 40739381
Identifiers
NCT: NCT05637086 · 22.09.108