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| Name | Class |
|---|---|
| Tanta University | OTHER |
| Principal Investigator Maha Ahmed Younis, PhD Pharmacy Practice Department- Horus University | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Experimental | This group will receive 100 mg of phenytoin 3 times daily for 6 months. |
|
| Pentoxifylline group | Active Comparator | This group will receive 100 mg of phenytoin 3 times daily plus pentoxifylline 400 mg two times daily for 6 months |
|
| Celecoxib group | Active Comparator | This group will receive 100 mg of phenytoin 3 times daily plus celecoxib 200 mg once daily for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phenytoin | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The clinical outcome will be assessed through Quality of Life questionnaire (QOLIE-31) | Caregivers will complete the questionnaire for assessing the quality of life in epileptic patients. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| The secondary outcome is the change in the serum level of the measured biological parameters | 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 | 6 months |
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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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mansoura University | Recruiting | Al Mansurah | 35516 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40739381 | Derived | 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. |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D010672 | Phenytoin |
| D010431 | Pentoxifylline |
| D000068579 | Celecoxib |
| ID | Term |
|---|---|
| D006827 | Hydantoins |
| D048289 | Imidazolidines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 |
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double-blinded.
| Pentoxifylline 400 MG | Drug | Pentoxifylline (PTX) has a well validated immune modulatory and anti-inflammatory efficacy |
|
| Celecoxib 200mg | Drug | Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild to moderate pain and help relieve symptoms of arthritis |
|
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013805 | Theobromine |
| D014970 | Xanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |