Back to resultsExpression of PARP-1 in Multiple Sclerosis Patients
Primary Purpose
Multiple Sclerosis
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Blood sampling
Sponsored by
About this trial
This is an interventional diagnostic trial for Multiple Sclerosis focused on measuring Optic neuritis-Multiple sclerosis-PARP-1
Eligibility Criteria
Inclusion Criteria:
- Patients with multiple sclerosis with or without optic neuritis Multiple sclerosis will be diagnosed according to the McDonald criteria
Exclusion Criteria:
- • Isolated optic neuritis.
Sites / Locations
- Elshimaa A.MateenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Active Comparator
Active Comparator
Arm Label
Control group
MS with optic neuritis
Ms without optic neuritis
Arm Description
Outcomes
Primary Outcome Measures
measure PARP-1 mRNA
measure PARP-1 mRNA
Secondary Outcome Measures
Optic nerve, RNFL and GCC layer affection by MS
Optic nerve Retinal nerve fibre layer (RNFL) in um
) and Ganglion cell complex (GCC) layer affection in um by MS in correlation to PARP-1 mRNA
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05196425
Brief Title
Expression of PARP-1 in Multiple Sclerosis Patients
Official Title
Expression of PARP-1 in Optic Neuritis of Multiple Sclerosis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
March 2022 (Anticipated)
Study Completion Date
April 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Optic neuritis-Multiple sclerosis-PARP-1
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Other
Arm Title
MS with optic neuritis
Arm Type
Active Comparator
Arm Title
Ms without optic neuritis
Arm Type
Active Comparator
Intervention Type
Genetic
Intervention Name(s)
Blood sampling
Intervention Description
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
Primary Outcome Measure Information:
Title
measure PARP-1 mRNA
Description
measure PARP-1 mRNA
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Optic nerve, RNFL and GCC layer affection by MS
Description
Optic nerve Retinal nerve fibre layer (RNFL) in um
) and Ganglion cell complex (GCC) layer affection in um by MS in correlation to PARP-1 mRNA
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients with multiple sclerosis with or without optic neuritis Multiple sclerosis will be diagnosed according to the McDonald criteria
Exclusion Criteria:
• Isolated optic neuritis.
Facility Information:
Facility Name
Elshimaa A.Mateen
City
Sohag
ZIP/Postal Code
82511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elshimaa A.Mateen, Dr
Phone
0021282223427
Email
elshimaa.moussa@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Expression of PARP-1 in Multiple Sclerosis Patients
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