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Relaxin in Multiple Sclerosis (MS)

Sponsor
Providence Health & Services (Other)
Overall Status
Recruiting
CT.gov ID
NCT01909492
Collaborator
Microstein, LLC (Other)
30
Enrollment
1
Location
119.4
Anticipated Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will evaluate relaxin (RLX) and Semaphorin 4A (Sema4A) levels in patients with multiple sclerosis.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Blood Draw
  • Procedure: Lumbar Puncture

Detailed Description

The goal of this study is to obtain baseline information on serum and cerebrospinal fluid (CSF) relaxin and Sema4A levels in patients with MS, as well as to further study RXFP-1 receptor binding affinity for RLX in patients with active and clinically stable MS, and further characterize the role of Sema4A in MS patients.

Study Design

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Measurement of Relaxin in the Serum and Cerebrospinal Fluid of Subjects With and Without the Relapsing Form of Multiple Sclerosis
Actual Study Start Date :
Sep 20, 2013
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Group 1

Group 1 will consist of 10 subjects with suspected MS, who have had a clinical attack within the last 12 weeks, have at least one gadolinium-enhancing lesion on brain or spinal cord MRI taken within the prior 4 weeks, and for which they have not received any immunomodulating or immunosuppressant medication. Patients will have a blood draw to provide serum and a CSF will be obtained through a lumbar puncture.

Procedure: Blood Draw
Patients will provide a serum sample for research.

Procedure: Lumbar Puncture
Patients will have a lumbar puncture to obtain CSF.
Other Names:
  • Spinal tap
  • LP

    		•
    Group 2

    Group 2 will consist of 10 subjects with clinically stable definite MS, with no evidence of clinical relapse for at least the past 12 weeks, and have no gadolinium enhancing lesions on MRI in the prior 4 weeks. These subjects will fulfill the Revised (2010) McDonald's Criteria for the Diagnosis of MS. Patients will have a blood draw to provide serum and a CSF will be obtained through a lumbar puncture.

    Procedure: Blood Draw
    Patients will provide a serum sample for research.

    Procedure: Lumbar Puncture
    Patients will have a lumbar puncture to obtain CSF.
    Other Names:
  • Spinal tap
  • LP

    		•
    Group 3

    Group 3 will consist of 10 subjects without evidence of inflammatory systemic or inflammatory central nervous system disease, who require CSF removal for some other cause, such treatment of benign intracranial hypertension or as part of the procedure for insertion of an intrathecal medication delivery system. Patients will have a blood draw to provide serum and a CSF will be obtained through a lumbar puncture.

    Procedure: Blood Draw
    Patients will provide a serum sample for research.

    Procedure: Lumbar Puncture
    Patients will have a lumbar puncture to obtain CSF.
    Other Names:
  • Spinal tap
  • LP

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Relaxin (RLX) Levels [During diagnostic LP]

      There is no information available on what serum and CSF levels of RLX are observed in patients with active versus stable relapsing MS, how these values compare to that found in human volunteers without MS or other inflammatory diseases, and whether RLX functions normally in subjects with active or stable MS.

    Secondary Outcome Measures

    1. Sema4A levels [During diagnostic LP]

      Evaluation of sema 4A levels during acute inflammatory and stable patients with relapsing form of MS

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Subjects with suspected MS, who have had a clinical attack within the last 12 weeks, have at least one gadolinium-enhancing lesion on brain or spinal cord MRI taken within the prior 4 weeks, and for which they have not received any immunomodulating or immunosuppressant medication.

    • Subjects with clinically stable definite MS, with no evidence of clinical relapse for at least the past 12 weeks, and have no gadolinium enhancing lesions on MRI in the prior 4 weeks. These subjects will fulfill the Revised (2010) McDonald's Criteria for the Diagnosis of MS.

    • Subjects without evidence of inflammatory systemic or inflammatory central nervous system disease, who require CSF removal for some other cause, such treatment of benign intracranial hypertension or as part of the procedure for insertion of an intrathecal medication delivery system.

    Exclusion Criteria:
    • Pregnancy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Providence MS Center Portland Oregon United States 97225

    Sponsors and Collaborators

    • Providence Health & Services
    • Microstein, LLC

    Investigators

    • Principal Investigator: Stanley Cohan, MD, PhD, Providence Brain & Spine Institute, Providence Health & Services

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Providence Health & Services
    ClinicalTrials.gov Identifier:
    NCT01909492
    Other Study ID Numbers:
    • 13-089B
    First Posted:
    Jul 26, 2013
    Last Update Posted:
    Feb 18, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Providence Health & Services
    Multiple Sclerosis
    MS
    Relaxin
    Additional relevant MeSH terms:
    Multiple Sclerosis
    Multiple Sclerosis, Relapsing-Remitting
    Sclerosis

    Study Results

    No Results Posted as of Feb 18, 2022