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Completed

NCT Number: NCT01909492

Measurement of Relaxin Peptide in Multiple Sclerosis (MS)

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

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Key information

Conditions

Multiple Sclerosis, Relapsing-Remitting Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Nervous System Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Providence MS Center

Portland, Oregon, 97225, United States

About this study

The goal of this study is to obtain baseline information on serum and cerebrospinal fluid (CSF) relaxin 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood draw

Procedure

Patients will provide a serum sample for research.

Lumbar Puncture

Procedure

Patients will have a lumbar puncture to obtain CSF.

Other names: Spinal tap, LP

Primary outcomes

  1. Relaxin (RLX) Levels

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

Sponsors and collaborators

Lead sponsor

Providence Health & Services

Other

Collaborators

  • Microstein, LLC

Registry information

Official study title

Measurement of Relaxin in the Serum and Cerebrospinal Fluid of Subjects With and Without the Relapsing Form of Multiple Sclerosis

Important dates

Study start
2013
Primary completion
2023
Study completion
2023
First posted
Jul 26, 2013
Registry last updated
Jun 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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