Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04380220
Other study ID # 972/17
Secondary ID PE-2013-02357745
Status Active, not recruiting
Phase
First received
Last updated
Start date September 7, 2017
Est. completion date December 31, 2020

Study information

Verified date May 2020
Source Regina Elena Cancer Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

This is a multi-center, prospective, controlled study. MS patients (1° group: 30 patients in relapse; 2° group: 30 patients in remission) and age/sex-matched healthy controls (3° group: 30 subjects) will be enrolled in the study. Patients' disability level will be evaluated by EDSS and MSFC.

Patients and controls will be tested for either coagulation/complement (C3, C4, C4a, C9, fibrinogen, factor VIII and X, D-dimer, protein C, protein S, antithrombin, factor II, aPTT, von-Willebrand factor), soluble markers of endothelial damage (thrombomodulin, Endothelial Protein C Receptor), antiphospholipid antibodies, lupus anticoagulant, complete blood count, viral serological assays or microRNA microarray.

Patients will undergo dynamic susceptibility contrast-enhanced MRI using a 3.0-T scanner to evaluate CBF, CBV, MTT, lesion number and volume.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 80
Est. completion date December 31, 2020
Est. primary completion date August 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- patients diagnosed with relapsing-remitting multiple sclerosis, untreated or treated with only immunomodulatory therapy, in relapse o in remission

Exclusion Criteria:

- pregnant, with any neoplastic, hematologic, thyroid, metabolic, thrombotic or autoimmune disease, drug or alcohol addicted, treated with immunosuppressive drugs, steroids o any medication interfering with coagulation.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Blood samples and processing
DSC perfusion technique at 3.0-T MRI only in MS patients

Locations

Country Name City State
Italy IRCCS Regina Elena National Cancer Institute Rome
Italy University of Rome Sapienza Rome
United States Icahn School of Medicine at Mount Sinai New York New York

Sponsors (3)

Lead Sponsor Collaborator
Regina Elena Cancer Institute Icahn School of Medicine at Mount Sinai, University of Roma La Sapienza

Countries where clinical trial is conducted

United States,  Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary plasma concentration of coagulation factor Factor VIII (%) through study completion, an average of 1 year
Primary plasma concentration of coagulation factor Factor X (%) through study completion, an average of 1 year
Primary plasma concentration of coagulation factor D-dimer (ng/ml) through study completion, an average of 1 year
Primary plasma concentration of coagulation factor Protein C (%) through study completion, an average of 1 year
Primary plasma concentration of coagulation factor Protein S (%) through study completion, an average of 1 year
Primary plasma concentration of coagulation factor Fibrinogen (mg/dl) through study completion, an average of 1 year
Primary plasma concentration of coagulation factor complement (mg/dl) through study completion, an average of 1 year
Secondary Brain MRI hemodynamic changes at DSC 3.0-T MRI cerebral blood flow through study completion, an average of 1 year
Secondary Brain MRI hemodynamic changes at DSC 3.0-T MRI cerebral blood volume through study completion, an average of 1 year
Secondary Brain MRI hemodynamic changes at DSC 3.0-T MRI mean transit time through study completion, an average of 1 year
See also
  Status Clinical Trial Phase
Completed NCT05528666 - Risk Perception in Multiple Sclerosis
Completed NCT03608527 - Adaptive Plasticity Following Rehabilitation in Multiple Sclerosis N/A
Recruiting NCT05532943 - Evaluate the Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cells in Patients With Multiple Sclerosis Phase 1/Phase 2
Completed NCT02486640 - Evaluation of Potential Predictors of Adherence by Investigating a Representative Cohort of Multiple Sclerosis (MS) Patients in Germany Treated With Betaferon
Completed NCT01324232 - Safety and Efficacy of AVP-923 in the Treatment of Central Neuropathic Pain in Multiple Sclerosis Phase 2
Completed NCT04546698 - 5-HT7 Receptor Implication in Inflammatory Mechanisms in Multiple Sclerosis
Completed NCT02835677 - Integrating Caregiver Support Into MS Care N/A
Completed NCT03686826 - Feasibility and Reliability of Multimodal Evoked Potentials
Recruiting NCT05964829 - Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis N/A
Withdrawn NCT06021561 - Orofacial Pain in Multiple Sclerosis
Completed NCT03653585 - Cortical Lesions in Patients With Multiple Sclerosis
Recruiting NCT04798651 - Pathogenicity of B and CD4 T Cell Subsets in Multiple Sclerosis N/A
Active, not recruiting NCT05054140 - Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis Phase 2
Completed NCT05447143 - Effect of Home Exercise Program on Various Parameters in Patients With Multiple Sclerosis N/A
Recruiting NCT06195644 - Effect of Galvanic Vestibular Stimulation on Cortical Excitability and Hand Dexterity in Multiple Sclerosis Patients Phase 1
Completed NCT04147052 - iSLEEPms: An Internet-Delivered Intervention for Sleep Disturbance in Multiple Sclerosis N/A
Completed NCT03591809 - Combined Exercise Training in Patients With Multiple Sclerosis N/A
Completed NCT03594357 - Cognitive Functions in Patients With Multiple Sclerosis
Completed NCT02845635 - MS Mosaic: A Longitudinal Research Study on Multiple Sclerosis
Completed NCT03269175 - BENEFIT 15 Long-term Follow-up Study of the BENEFIT and BENEFIT Follow-up Studies Phase 4