Multiple Sclerosis, Relapsing-Remitting
Conditions
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
Patients will provide a serum sample for research.
Patients will have a lumbar puncture to obtain CSF.
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Relaxin (RLX) Levels | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 30 |
Baseline characteristics
| Characteristic | Group 1 | Group 2 | Group 3 | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 10 Participants | 10 Participants | 30 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 8 Participants | 10 Participants | 9 Participants | 27 Participants |
| Region of Enrollment United States | 10 participants | 10 participants | 10 participants | 30 participants |
| Sex: Female, Male Female | 10 Participants | 10 Participants | 10 Participants | 30 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 5 / 10 | 9 / 10 | 10 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 10 |
Outcome results
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 | Relaxin (RLX) Levels | RLX2 concentration level solely in serum | NA pmol/mL |
| Group 1 | Relaxin (RLX) Levels | RLX2 concentration level solely in the CSF | NA pmol/mL |
| Group 2 | Relaxin (RLX) Levels | RLX2 concentration level solely in serum | NA pmol/mL |
| Group 2 | Relaxin (RLX) Levels | RLX2 concentration level solely in the CSF | NA pmol/mL |
| Group 3 | Relaxin (RLX) Levels | RLX2 concentration level solely in serum | NA pmol/mL |
| Group 3 | Relaxin (RLX) Levels | RLX2 concentration level solely in the CSF | NA pmol/mL |