NCT05196425

Brief Summary

This study will explore the expression of PARP-1 in optic neuritis of multiple sclerosis patients. The data will be collected from Sohag University hospital in the period from the start of August 2021 to the end of December 2021. The study protocol will be approved by the Scientific Research Ethical Committee, Faculty of Medicine, Sohag University.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P75+ for not_applicable multiple-sclerosis

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

August 1, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 19, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

May 2, 2025

Status Verified

April 1, 2025

Enrollment Period

8 months

First QC Date

December 7, 2021

Last Update Submit

April 29, 2025

Conditions

Multiple Sclerosis

Keywords

Optic neuritis-Multiple sclerosis-PARP-1

Outcome Measures

Primary Outcomes (1)

  • measure PARP-1 mRNA

    measure PARP-1 mRNA

    2 weeks

Secondary Outcomes (1)

  • Optic nerve, RNFL and GCC layer affection by MS

    2 weeks

Study Arms (3)

Control group

OTHER
Genetic: Blood sampling

MS with optic neuritis

ACTIVE COMPARATOR
Genetic: Blood sampling

Ms without optic neuritis

ACTIVE COMPARATOR
Genetic: Blood sampling

Interventions

Blood samplingGENETIC

Blood sample for detection of PARP-1 gene and correlate to changes of the optic disc, RNFL and GCC layers of the retina of MS patients

Control groupMS with optic neuritisMs without optic neuritis

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with multiple sclerosis with or without optic neuritis Multiple sclerosis will be diagnosed according to the McDonald criteria

You may not qualify if:

  • Isolated optic neuritis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elshimaa A.Mateen

Sohag, 82511, Egypt

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of ophthalmology

Study Record Dates

First Submitted

December 7, 2021

First Posted

January 19, 2022

Study Start

August 1, 2021

Primary Completion

March 30, 2022

Study Completion

April 30, 2022

Last Updated

May 2, 2025

Record last verified: 2025-04

Locations

EG(1)