NCT03217396 Biomarkers of Synaptic Damage in Multiple Sclerosis
| NCT ID | NCT03217396 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Neuromed IRCCS |
| Condition | Multiple Sclerosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2017-11-22 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2017-11-22 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A prospective and retrospective cohort study of about five years will be performed on blood and cerebrospinal fluid samples taken for diagnostic reasons from recruited patients within the Neuromed Neurology Unit. Subjects with other chronic neurodegenerative diseases such as Amyotrophic lateral sclerosis (ALS), Alzheimer's disease (AD) and Parkinson's disease (PD), and healthy subjects subjected to blood sampling and / or lumbar puncture for clinical reasons will be recruited As control groups.
Eligibility 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
Contact & Investigator
Diego Centonze, MD
PRINCIPAL INVESTIGATOR
IRCCS Neuromed
Frequently Asked Questions
Who can join the NCT03217396 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Multiple Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03217396 currently recruiting?
Yes, NCT03217396 is actively recruiting participants. Contact the research team at centonze@uniroma2.it for enrollment information.
Where is the NCT03217396 trial being conducted?
This trial is being conducted at Pozzilli, Italy.
Who is sponsoring the NCT03217396 clinical trial?
NCT03217396 is sponsored by Neuromed IRCCS. The principal investigator is Diego Centonze, MD at IRCCS Neuromed. The trial plans to enroll 300 participants.
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