EpilepsyPhase 2NCT05637086
Clinical Study Evaluating Safety of Pentoxifylline and Celecoxib in Patients With Grand-Mal Epilepsy Treated by Phenytoin Monotherapy
A Phase 2 study testing Phenytoin, Pentoxifylline 400 MG and Celecoxib 200mg in people with Epilepsy, run by Mostafa Bahaa at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Phenytoin, Pentoxifylline 400 MG and Celecoxib 200mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Dec 2022to 20 Nov 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Mansoura University
Al Mansurah, 35516
Maha Younis, PhD, 0201069491494, myounis@horus.edu.eg
About this study
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
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
- Epilepsy
- Being tested
- Phenytoin, Pentoxifylline 400 MG, Celecoxib 200mg
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhenytoinDrug
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
Pentoxifylline 400 MGDrug
Pentoxifylline (PTX) has a well validated immune modulatory and anti-inflammatory efficacy
Celecoxib 200mgDrug
Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild to moderate pain and help relieve symptoms of arthritis
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Experimental | This group will receive 100 mg of phenytoin 3 times daily for 6 months. Receives: Drug: Phenytoin |
| 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 Receives: Drug: Phenytoin; Drug: Pentoxifylline 400 MG |
| Celecoxib group | Active comparator | This group will receive 100 mg of phenytoin 3 times daily plus celecoxib 200 mg once daily for 6 months Receives: Drug: Phenytoin; Drug: Celecoxib 200mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start20 Dec 2022
- Primary completion20 Dec 2026 (estimated)
- Study completion20 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mostafa Bahaa
- Sponsor type
- University, hospital or other
- Collaborators
- Tanta University, Horus University
- Responsible party
- Sponsor-investigator, Mostafa Bahaa, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05637086
- Sponsor's protocol ID
- 22.09.108
- Status last verified
- Jul 2024
- First submitted
- 27 Nov 2022
- Last updated
- 18 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40739381
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05637086
- Acronym / sponsor ID
- 22.09.108
- Conditions
- Epilepsy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Mostafa BahaaUniversity, hospital or other
- Collaborators
- Tanta University, Horus University
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 20 Nov 2027 (estimated)
- First posted
- 5 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | Experimental | Drug: PhenytoinThis group will receive 100 mg of phenytoin 3 times daily for 6 months. |
| Pentoxifylline group | Active comparator | Drug: Phenytoin, Drug: Pentoxifylline 400 MGThis group will receive 100 mg of phenytoin 3 times daily plus pentoxifylline 400 mg two times daily for 6 months |
| Celecoxib group | Active comparator | Drug: Phenytoin, Drug: Celecoxib 200mgThis group will receive 100 mg of phenytoin 3 times daily plus celecoxib 200 mg once daily for 6 months |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged ≥ 18 years old. Patients with grand mal epilepsy on phenytoin monotherapy. Women with a negative pregnancy test and women on effective contraception
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhenytoinPhenytoin 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 | Celecoxib group, Control Group, Pentoxifylline group |
| Pentoxifylline 400 MGPentoxifylline (PTX) has a well validated immune modulatory and anti-inflammatory efficacy | Drug | Pentoxifylline group |
| Celecoxib 200mgCelecoxib is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild to moderate pain and help relieve symptoms of arthritis | Drug | Celecoxib group |
Primary outcome
The clinical outcome will be assessed through Quality of Life questionnaire (QOLIE-31)
Time frame: 6 months
Caregivers will complete the questionnaire for assessing the quality of life in epileptic patients.
1 secondary outcome
The secondary outcome is the change in the serum level of the measured biological parameters
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
- Derived from this study: PubMed 40739381Younis 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Phenytoin, Pentoxifylline 400 MG and Celecoxib 200mg in people with Epilepsy, run by Mostafa Bahaa at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The clinical outcome will be assessed through Quality of Life questionnaire (QOLIE-31) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05637086, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2024.