Measurement of Relaxin Peptide in Multiple Sclerosis (MS)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-09-20

Study Completion Date

2023-10-05

Brief Summary

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

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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.

Conditions

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Multiple Sclerosis, Relapsing-Remitting

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Blood Draw

Intervention Type PROCEDURE

Patients will provide a serum sample for research.

Lumbar Puncture

Intervention Type PROCEDURE

Patients will have a lumbar puncture to obtain CSF.

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.

Blood Draw

Intervention Type PROCEDURE

Patients will provide a serum sample for research.

Lumbar Puncture

Intervention Type PROCEDURE

Patients will have a lumbar puncture to obtain CSF.

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.

Blood Draw

Intervention Type PROCEDURE

Patients will provide a serum sample for research.

Lumbar Puncture

Intervention Type PROCEDURE

Patients will have a lumbar puncture to obtain CSF.

Interventions

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Blood Draw

Patients will provide a serum sample for research.

Intervention Type PROCEDURE

Lumbar Puncture

Patients will have a lumbar puncture to obtain CSF.

Intervention Type PROCEDURE

Other Intervention Names

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Spinal tap LP

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.