Multiple SclerosisNCT05196425
Expression of PARP-1 in Multiple Sclerosis Patients
A study testing Blood sampling in people with Multiple Sclerosis, run by Sohag University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Blood sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2021to 30 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with multiple sclerosis with or without optic neuritis Multiple sclerosis will be diagnosed according to the McDonald criteria
Who cannot join
- • Isolated optic neuritis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Expression of PARP-1 in Optic Neuritis of Multiple Sclerosis Patients
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.
- Conditions
- Multiple Sclerosis
- Being tested
- Blood sampling
- Keywords
- Optic neuritis-Multiple sclerosis-PARP-1
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | Not described Receives: Genetic: Blood sampling |
| MS with optic neuritis | Active comparator | Not described Receives: Genetic: Blood sampling |
| Ms without optic neuritis | Active comparator | Not described Receives: Genetic: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
measure PARP-1 mRNA
measure PARP-1 mRNA
Measured: 2 weeks
Secondary outcomes (1)
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
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start1 Aug 2021
- Primary completion30 Mar 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elshimaa A.Mateen, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05196425
- Sponsor's protocol ID
- Soh-Med-21-05-12
- Status last verified
- Apr 2025
- First submitted
- 7 Dec 2021
- Last updated
- 2 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression of PARP-1 in Optic Neuritis of Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT05196425
- Acronym / sponsor ID
- Soh-Med-21-05-12
- Conditions
- Multiple Sclerosis
- Keywords
- Optic neuritis-Multiple sclerosis-PARP-1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 19 Jan 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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Genetic: Blood sampling |
| MS with optic neuritis | Active comparator | Genetic: Blood sampling |
| Ms without optic neuritis | Active comparator | Genetic: Blood sampling |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with multiple sclerosis with or without optic neuritis Multiple sclerosis will be diagnosed according to the McDonald criteria
Key exclusion criteria (1 listed)
- • Isolated optic neuritis.
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 |
|---|---|---|
| Blood samplingBlood 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 | Genetic | Control group, MS with optic neuritis, Ms without optic neuritis |
Primary outcome
measure PARP-1 mRNA
Time frame: 2 weeks
measure PARP-1 mRNA
1 secondary outcome
Optic nerve, RNFL and GCC layer affection by MS
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling in people with Multiple Sclerosis, run by Sohag University 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 1 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: finished, as of the sponsor's last update on 2 May 2025. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measure PARP-1 mRNA (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 May 2025.