Measurement of Relaxin Peptide in Multiple Sclerosis (MS)

Providence Health & Services

Status: Completed

Conditions: Multiple Sclerosis, Relapsing-Remitting

Treatments: Procedure: Lumbar Puncture; Procedure: Blood Draw

Study type: Observational

Funder types: Other

Identifiers

NCT01909492

13-089B

Details and patient eligibility

About

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

Full description

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.

Enrollment: 30 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

30 participants in 3 patient groups

Group 1

Description:

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.

Treatment:

Procedure: Blood Draw

Procedure: Lumbar Puncture

Group 2

Description:

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.

Treatment:

Procedure: Blood Draw

Procedure: Lumbar Puncture

Group 3

Description:

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.

Treatment:

Procedure: Blood Draw

Procedure: Lumbar Puncture