Clinical Study Evaluating Safety of Pentoxifylline and Celecoxib in Patients With Grand-Mal Epilepsy Treated by Phenytoin Monotherapy
NCT05637086 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90
Last updated 2024-07-18
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.
Conditions
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
Sponsors & Collaborators
-
Tanta University
collaborator OTHER -
Principal Investigator Maha Ahmed Younis, PhD Pharmacy Practice Department- Horus University
collaborator UNKNOWN -
Mostafa Bahaa
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-12-20
- Primary Completion
- 2026-12-20
- Completion
- 2027-11-20
Countries
- Egypt
Study Locations
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