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Taking people in EgyptPhase 2

Tests pentoxifylline and celecoxib added to phenytoin for epilepsy

Tests two added drugs alongside phenytoin in adults with grand-mal epilepsy.

Key facts

Who runs it
Mostafa Bahaa
Where
Al Mansurah, EgyptSee the site
Trial code
Registry title
Clinical Study Evaluating Safety of Pentoxifylline and Celecoxib in Patients With Grand-Mal Epilepsy Treated by Phenytoin Monotherapy
Status
Recruiting
Phase
Phase 2
People taking part
90 people, planned
Started
20 Dec 2022
Expected to end
20 Nov 2027
Type of study
Interventional, 3 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Phenytoin
  • Pentoxifylline 400 MG
  • Celecoxib 200mg
Record updated
18 July 2024

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with grand mal epilepsy who take phenytoin as their only epilepsy medicine.

Age
18 to 75 years
Sex
All sexes can join.
Disease stage
Grand mal epilepsy.
Earlier treatment
Must be on phenytoin alone. Cannot be using other epilepsy drugs.

Main reasons for not taking part

  • Significant liver or kidney problems
  • Alcohol or drug abuse
  • Known allergy to the study drugs or to sulfonamides
  • Pregnant women or women planning a pregnancy
  • Heart disease or past coronary bypass surgery

The registry criteria, word for word

Show all 2 criteriaShow less

Who can take part

  • Patients aged ≥ 18 years old. Patients with grand mal epilepsy on phenytoin monotherapy. Women with a negative pregnancy test and women on effective contraception

Who cannot take part

  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 75 years old?

Where in Egypt

  • Mansoura UniversityAl Mansurah, EgyptContact: Maha Younis, PhDTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

Neuroinflammation is considered one of the most important factors contributing critically to epileptogenesis.

The 3 groups in the trial

  • Control GroupTreatment being tested

    This group will receive 100 mg of phenytoin 3 times daily for 6 months.

    Treatment: Phenytoin

  • Pentoxifylline groupExisting treatment, for comparison

    This group will receive 100 mg of phenytoin 3 times daily plus pentoxifylline 400 mg two times daily for 6 months

    Treatment: Phenytoin and Pentoxifylline 400 MG

  • Celecoxib groupExisting treatment, for comparison

    This group will receive 100 mg of phenytoin 3 times daily plus celecoxib 200 mg once daily for 6 months

    Treatment: Phenytoin and Celecoxib 200mg

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Plain-language title
Tests pentoxifylline and celecoxib added to phenytoin for epilepsyGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT05637086, who can take part
Record updated
18 July 2024