Measurement of Relaxin Peptide in Multiple Sclerosis (MS)

Study Overview
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Brief Summary
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This study will evaluate relaxin (RLX) levels in patients with multiple sclerosis.

Detailed Description
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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.

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

Conditions
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Multiple Sclerosis, Relapsing-Remitting

Intervention / Treatment
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* Procedure: Blood Draw
* Procedure: Lumbar Puncture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>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<br>* Patients will provide a serum sample for research.<br>Procedure: Lumbar Puncture<br>* Patients will have a lumbar puncture to obtain CSF.<br>* Other names: LP;|
| Group 2<br>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<br>* Patients will provide a serum sample for research.<br>Procedure: Lumbar Puncture<br>* Patients will have a lumbar puncture to obtain CSF.<br>* Other names: LP;|
| Group 3<br>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<br>* Patients will provide a serum sample for research.<br>Procedure: Lumbar Puncture<br>* Patients will have a lumbar puncture to obtain CSF.<br>* Other names: LP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | During diagnostic LP | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Sclerosis, MS, Relaxin