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
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• \- Patients aged ≥ 18 years old. Patients with grand mal epilepsy on phenytoin monotherapy. Women with a negative pregnancy test and women on effective contraception
Locations
Other Locations
Egypt
Mansoura University
RECRUITING
Al Mansurah
Time Frame
Start Date: 2022-12-20
Estimated Completion Date: 2027-11-20
Participants
Target number of participants: 90
Treatments
Experimental: Control Group
This group will receive 100 mg of phenytoin 3 times daily for 6 months.
Active_comparator: Pentoxifylline group
This group will receive 100 mg of phenytoin 3 times daily plus pentoxifylline 400 mg two times daily for 6 months
Active_comparator: Celecoxib group
This group will receive 100 mg of phenytoin 3 times daily plus celecoxib 200 mg once daily for 6 months
Sponsors
Leads: Mostafa Bahaa
Collaborators: Principal Investigator Maha Ahmed Younis, PhD Pharmacy Practice Department- Horus University, Tanta University