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Measurement of Relaxin Peptide in Multiple Sclerosis (MS)

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01909492
Enrollment
30
Registered
2013-07-26
Start date
2013-09-20
Completion date
2023-10-05
Last updated
2025-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Keywords

Multiple Sclerosis, MS, Relaxin

Brief summary

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

Detailed 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.

Interventions

PROCEDUREBlood Draw

Patients will provide a serum sample for research.

PROCEDURELumbar Puncture

Patients will have a lumbar puncture to obtain CSF.

Sponsors

Microstein, LLC
CollaboratorUNKNOWN
Providence Health & Services
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Relaxin (RLX) LevelsDuring diagnostic LPThere 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
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: Patients will provide a serum sample for research. Lumbar Puncture: Patients will have a lumbar puncture to obtain CSF.
10
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: Patients will provide a serum sample for research. Lumbar Puncture: Patients will have a lumbar puncture to obtain CSF.
10
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: Patients will provide a serum sample for research. Lumbar Puncture: Patients will have a lumbar puncture to obtain CSF.
10
Total30

Baseline characteristics

CharacteristicGroup 1Group 2Group 3Total
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
10 Participants10 Participants10 Participants30 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
1 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
Black or African American
1 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants1 Participants1 Participants
Race (NIH/OMB)
White
8 Participants10 Participants9 Participants27 Participants
Region of Enrollment
United States
10 participants10 participants10 participants30 participants
Sex: Female, Male
Female
10 Participants10 Participants10 Participants30 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 100 / 100 / 10
other
Total, other adverse events
5 / 109 / 1010 / 10
serious
Total, serious adverse events
0 / 100 / 100 / 10

Outcome results

Primary

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.

Time frame: During diagnostic LP

ArmMeasureGroupValue (NUMBER)
Group 1Relaxin (RLX) LevelsRLX2 concentration level solely in serumNA pmol/mL
Group 1Relaxin (RLX) LevelsRLX2 concentration level solely in the CSFNA pmol/mL
Group 2Relaxin (RLX) LevelsRLX2 concentration level solely in serumNA pmol/mL
Group 2Relaxin (RLX) LevelsRLX2 concentration level solely in the CSFNA pmol/mL
Group 3Relaxin (RLX) LevelsRLX2 concentration level solely in serumNA pmol/mL
Group 3Relaxin (RLX) LevelsRLX2 concentration level solely in the CSFNA pmol/mL

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026