Identifying biomarkers of synaptic damage in multiple sclerosis
Official title: Identification of New Biomarkers Useful to Define the Course of Multiple Sclerosis and Study of the Mechanisms That Promote Synaptic Damage
Run by Neuromed IRCCS · NCT03217396 · Data updated 2026-11-12
This study is testing blood and spinal fluid samples from people with multiple sclerosis to see if certain markers can help us understand brain changes and how the disease progresses.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Neuromed IRCCS Academic / other |
| Locations | 1 site (Pozzilli, Isernia) |
| Status | Recruiting |
| Started | November 22, 2017 |
| Main results expected | September 1, 2026 |
| Study ends | September 30, 2027 |
| Registry record updated | October 28, 2022 |
| Trial ID | NCT03217396 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are males and females aged 18 to 65 with a confirmed diagnosis of multiple sclerosis and an EDSS score between 0 and 5.5.
✕Probably not a fit
Patients unable to provide informed consent or those with significant comorbid conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study will analyze blood and cerebrospinal fluid samples from patients diagnosed with multiple sclerosis and other neurodegenerative diseases over a five-year period. The study aims to evaluate levels of various biomarkers, including microRNAs, cytokines, and neuronal damage markers, to understand synaptic alterations associated with multiple sclerosis. Additionally, genotyping studies will be conducted to identify genetic variations that may correlate with clinical parameters and disease progression. Control groups will include healthy subjects and patients with other chronic neurodegenerative diseases.
Why it matters
Potential benefit: If successful, this study could lead to the identification of novel biomarkers that improve diagnosis and monitoring of multiple sclerosis.
How similar studies have gone: Other studies have shown promise in identifying biomarkers for neurodegenerative diseases, but this specific approach focusing on synaptic damage in multiple sclerosis is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male and female patients (age between 18 and 65 years) 2. Diagnosis of MS in accordance with McDonald's (2010 rev) criteria, 3. EDSS between 0 and 5.5 (included), 4. Patients able to provide informed consent to participation in the study Exclusion Criteria: 1. Inability to provide informed written consent 2. Altered basal blood count 3. Pregnancy or lactation 4. Contraindications for the execution of magnetic resonance imaging with gadolinium 5. Significant clinical conditions in addition to SM or other chronic neurodegenerative diseases including latent viral infections
Where it's running
-
IRCCS Neuromed
Pozzilli, Isernia, Italy Recruiting
Study contacts
- Principal investigator: Diego Centonze, MD — IRCCS Neuromed
- Study coordinator: Diego Centonze, MD
- Email: centonze@uniroma2.it
- Phone: +39 3934444159
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.