NCT05637086

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
19mo left

Started Dec 2022

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Dec 2022Nov 2027

First Submitted

Initial submission to the registry

November 27, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 5, 2022

Completed
15 days until next milestone

Study Start

First participant enrolled

December 20, 2022

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2026

Expected
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2027

Last Updated

July 18, 2024

Status Verified

July 1, 2024

Enrollment Period

4 years

First QC Date

November 27, 2022

Last Update Submit

July 16, 2024

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • The secondary outcome is the change in the serum level of the measured biological parameters

    6 months

Study Arms (3)

Control Group

EXPERIMENTAL

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

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

Drug: PhenytoinDrug: 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

Drug: PhenytoinDrug: Celecoxib 200mg

Interventions

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

Celecoxib groupControl GroupPentoxifylline group
Pentoxifylline 400 MGDRUG

Pentoxifylline (PTX) has a well validated immune modulatory and anti-inflammatory efficacy

Pentoxifylline group
Celecoxib 200mgDRUG

Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild to moderate pain and help relieve symptoms of arthritis

Celecoxib group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University

Al Mansurah, 35516, Egypt

RECRUITING

Related Publications (1)

  • 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.

    PMID: 40739381DERIVED

MeSH Terms

Conditions

Epilepsy

Interventions

PhenytoinPentoxifyllineCelecoxib

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

HydantoinsImidazolidinesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTheobromineXanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingBenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazoles

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
double-blinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Teaching Assistant

Study Record Dates

First Submitted

November 27, 2022

First Posted

December 5, 2022

Study Start

December 20, 2022

Primary Completion (Estimated)

December 20, 2026

Study Completion (Estimated)

November 20, 2027

Last Updated

July 18, 2024

Record last verified: 2024-07

Locations

EG(1)