Measurement of Relaxin Peptide in Multiple Sclerosis (MS)

NCT01909492 | Completed Results

• 1 other identifier: 13-089B
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate relaxin (RLX) levels in patients with multiple sclerosis.

Conditions

Multiple Sclerosis, Relapsing-Remitting

Keywords

Multiple Sclerosis; MS; Relaxin

Outcome Measures

Primary Outcomes (1)

• Relaxin (RLX) Levels

  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. RLX2 concentrations were expressed as picomoles per milliliter (pmol/mL) of serum or CSF.

  During diagnostic LP

Study Arms (3)

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; Procedure: Lumbar Puncture

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; Procedure: Lumbar Puncture

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; Procedure: Lumbar Puncture

Interventions

Blood Draw PROCEDURE

Patients will provide a serum sample for research.

Group 1; Group 2; Group 3

Lumbar Puncture PROCEDURE

Patients will have a lumbar puncture to obtain CSF.

Also known as: Spinal tap, LP

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with suspected MS undergoing a lumbar puncture for diagnosis, patients with stable MS willing to participate in the study, and patients without MS having a lumbar puncture as part of their non-MS disease management will be invited to participate in this study.

You may qualify if:

• 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.

You may not qualify if:

• \- Pregnancy

Sponsors & Collaborators

• Providence Health & Services: lead
• Microstein, LLC: collaborator

Study Sites (1)

Providence MS Center

Portland, Oregon, 97225, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Patients will provide blood and cerebrospinal fluid for use in this research.

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis

Interventions

Blood Specimen Collection; Spinal Puncture

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Biopsy; Diagnostic Techniques, Neurological; Therapeutics

Limitations and Caveats

Shortcomings of this study that may have confounded the data or its interpretation include the small sample sizes, no diagnostic group exceeding 10 volunteers, sample acquisition and handling and/or damage in shipment to Quanterix laboratories.

Results Point of Contact

• Title: Director of PBSI /WC Clinical Research Program
• Organization: Providence Health & Services

Chiayi.Chen@providence.org

(503) 216-1012

Study Officials

• Stanley Cohan, MD, PhD

  Providence Brain & Spine Institute, Providence Health & Services

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2013
• First Posted: July 26, 2013
• Study Start: September 20, 2013
• Primary Completion: October 5, 2023
• Study Completion: October 5, 2023
• Last Updated: June 22, 2025
• Results First Posted: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)