Evaluating the safety of Pentoxifylline and Celecoxib for patients with Grand-Mal Epilepsy on Phenytoin
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
This study tests if combining Pentoxifylline and Celecoxib is safe for adults with Grand-Mal Epilepsy who are already taking Phenytoin.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Al Mansurah) |
| Trial ID | NCT05637086 on ClinicalTrials.gov |
What this trial studies
This clinical study aims to evaluate the safety of combining Pentoxifylline and Celecoxib in patients suffering from Grand-Mal Epilepsy who are currently treated with Phenytoin monotherapy. The study focuses on understanding the effects of these medications on neuroinflammation, which is a significant factor in the development of epilepsy. Participants will be monitored for any adverse effects and overall safety during the treatment period. The study is designed for adults aged 18 and older who meet specific inclusion criteria.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with Grand-Mal Epilepsy currently treated with Phenytoin monotherapy.
Not a fit: Patients with significant liver or kidney function abnormalities, those with a history of substance abuse, or those currently using other antiepileptic drugs may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective treatment option for patients with Grand-Mal Epilepsy.
How similar studies have performed: While the specific combination of Pentoxifylline and Celecoxib in this context is novel, previous studies have explored the role of neuroinflammation in epilepsy treatment with varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Al Mansurah
- Mansoura University — Al Mansurah, Egypt (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.