Clinical Study Evaluating Safety of Pentoxifylline in Patients With Grand-Mal Epilepsy Treated by Phenytoin Monotherapy

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Primary Purpose

Status

Recruiting

Phase

Phase 2

Locations

Egypt

Study Type

Interventional

Intervention

Phenytoin

Pentoxifylline 400 MG

About this trial

This is an interventional treatment trial for Epilepsy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Mansoura UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Control Group

Pentoxifylline group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

NCT ID

NCT05637086

First Posted

November 27, 2022

Last Updated

February 7, 2023

Sponsor

Mostafa Bahaa

Collaborators

Sahar El-Haggar, Prof Clinical pharmacy Department- Tanta University, Principal Investigator Maha Ahmed Younis, PhD Pharmacy Practice Department- Horus University, Tarek Mohamed Mostafa, Prof Clinical pharmacy Department- Tanta University

1. Study Identification

Unique Protocol Identification Number

NCT05637086

Brief Title

Clinical Study Evaluating Safety of Pentoxifylline in Patients With Grand-Mal Epilepsy Treated by Phenytoin Monotherapy

Official Title

Clinical Study Evaluating and Comparing the Safety and the Possible Efficacy of Pentoxifylline in Patients With Grand-Mal Epilepsy Treated by Phenytoin Monotherapy

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 20, 2022 (Actual)

Primary Completion Date

December 20, 2026 (Anticipated)

Study Completion Date

November 20, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Mostafa Bahaa

Collaborators

Sahar El-Haggar, Prof Clinical pharmacy Department- Tanta University, Principal Investigator Maha Ahmed Younis, PhD Pharmacy Practice Department- Horus University, Tarek Mohamed Mostafa, Prof Clinical pharmacy Department- Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Epilepsy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Masking Description

double-blinded.

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control Group

Arm Type

Experimental

Arm Description

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

Arm Title

Pentoxifylline group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Phenytoin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Pentoxifylline 400 MG

Intervention Description

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

Primary Outcome Measure Information:

Title

The clinical outcome will be assessed through Quality of Life questionnaire (QOLIE-31)

Description

Caregivers will complete the questionnaire for assessing the quality of life in epileptic patients.

Time Frame

6 months

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Facility Information:

Facility Name

Mansoura University

City

Mansoura

ZIP/Postal Code

35516

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maha Younis, PhD

Phone

0201069491494

Email

myounis@horus.edu.eg

Epilepsy

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial