Biomarkers of Synaptic Damage in Multiple Sclerosis
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ClinicalTrials.gov Identifier: NCT03217396 |
Recruitment Status :
Recruiting
First Posted : July 14, 2017
Last Update Posted : October 28, 2022
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Condition or disease | Intervention/treatment |
---|---|
Multiple Sclerosis Parkinson Disease Amyotrophic Lateral Sclerosis Alzheimer Disease | Procedure: lumbar puncture |
Study Type : | Observational |
Estimated Enrollment : | 300 participants |
Observational Model: | Case-Control |
Time Perspective: | Other |
Official Title: | Identification of New Biomarkers Useful to Define the Course of Multiple Sclerosis and Study of the Mechanisms That Promote Synaptic Damage |
Actual Study Start Date : | November 22, 2017 |
Estimated Primary Completion Date : | September 1, 2026 |
Estimated Study Completion Date : | September 30, 2027 |

Group/Cohort | Intervention/treatment |
---|---|
multiple sclerosis patients
lumbar puncture, microRNAs quantification in blood and CSF samples, SNPs analysis
|
Procedure: lumbar puncture
lumbar puncture performed to detect OCB for diagnostic purposes |
neurodegenerative disease patients
lumbar puncture, microRNAs quantification in blood and CSF samples, SNPs analysis
|
Procedure: lumbar puncture
lumbar puncture performed to detect OCB for diagnostic purposes |
control subjects
lumbar puncture, microRNAs quantification in blood and CSF samples, SNPs analysis
|
Procedure: lumbar puncture
lumbar puncture performed to detect OCB for diagnostic purposes |
- Identification of predictive biomarkers of SM using an ex vivo chimeric model [ Time Frame: September 01 2020 ]CSF concentrations of: neurofilaments, beta amyloid, tau protein, inflammatory cytokines and microRNAs
- Identification of new therapeutic targets in MS. [ Time Frame: September 01 2020 ]CSF concentrations of: neurofilaments, beta amyloid, tau protein, inflammatory cytokines and microRNAs
Biospecimen Retention: Samples With DNA

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- Male and female patients (age between 18 and 65 years)
- Diagnosis of MS in accordance with McDonald's (2010 rev) criteria,
- EDSS between 0 and 5.5 (included),
- Patients able to provide informed consent to participation in the study
Exclusion Criteria:
- Inability to provide informed written consent
- Altered basal blood count
- Pregnancy or lactation
- Contraindications for the execution of magnetic resonance imaging with gadolinium
- Significant clinical conditions in addition to SM or other chronic neurodegenerative diseases including latent viral infections

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03217396
Contact: Diego Centonze, MD | +39 3934444159 | centonze@uniroma2.it | |
Contact: Mario Stampanoni Bassi, MD | +39 3460181370 | mario_sb@hotmail.it |
Italy | |
IRCCS Neuromed | Recruiting |
Pozzilli, Isernia, Italy, 86077 | |
Contact: Stefania Passarelli +39 0865.915217 direzionescientifica@neuromed.it |
Principal Investigator: | Diego Centonze, MD | IRCCS Neuromed |
Responsible Party: | Mario Stampanoni Bassi, Principal Investigator, Neuromed IRCCS |
ClinicalTrials.gov Identifier: | NCT03217396 |
Other Study ID Numbers: |
IRCCS Neuromed |
First Posted: | July 14, 2017 Key Record Dates |
Last Update Posted: | October 28, 2022 |
Last Verified: | October 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
synaptic plasticity neuroinflammation neurodegeneration |
Parkinson Disease Multiple Sclerosis Alzheimer Disease Motor Neuron Disease Amyotrophic Lateral Sclerosis Sclerosis Pathologic Processes Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Synucleinopathies Neurodegenerative Diseases |
Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Demyelinating Diseases Autoimmune Diseases Immune System Diseases Dementia Tauopathies Neurocognitive Disorders Mental Disorders Neuromuscular Diseases Spinal Cord Diseases TDP-43 Proteinopathies Proteostasis Deficiencies Metabolic Diseases |