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| Name | Class |
|---|---|
| Microstein, LLC | UNKNOWN |
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This study will evaluate relaxin (RLX) levels in patients with multiple sclerosis.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood Draw | Procedure | Patients will provide a serum sample for research. |
|
| 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. RLX2 concentrations were expressed as picomoles per milliliter (pmol/mL) of serum or CSF. | During diagnostic LP |
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Inclusion Criteria:
Exclusion Criteria:
- Pregnancy
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Patients with suspected MS undergoing a lumbar puncture for diagnosis, patients with stable MS willing to participate in the study, and patients without MS having a lumbar puncture as part of their non-MS disease management will be invited to participate in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Stanley Cohan, MD, PhD | Providence Brain & Spine Institute, Providence Health & Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Providence MS Center | Portland | Oregon | 97225 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | pmol/mL | During diagnostic LP |
|
Approximately 24 hours after the LP procedure research staff will contact the patient by phone to discuss any symptoms or serious adverse events
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Generalized soreness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
Shortcomings of this study that may have confounded the data or its interpretation include the small sample sizes, no diagnostic group exceeding 10 volunteers, sample acquisition and handling and/or damage in shipment to Quanterix laboratories.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of PBSI /WC Clinical Research Program | Providence Health & Services | (503) 216-1012 | Chiayi.Chen@providence.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 4, 2023 | Apr 15, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D013129 | Spinal Puncture |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Patients will provide blood and cerebrospinal fluid for use in this research.
| Lumbar Puncture | Procedure | Patients will have a lumbar puncture to obtain CSF. |
|
|
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. |
| OG002 | 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. |
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|
| 0 |
| 10 |
| 0 |
| 10 |
| 5 |
| 10 |
| EG001 | 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. | 0 | 10 | 0 | 10 | 9 | 10 |
| EG002 | 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. | 0 | 10 | 0 | 10 | 10 | 10 |
| Headache/Headaches | Nervous system disorders | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Low back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Back soreness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Low back tenderness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Back ache | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Headache secondary to lumbar puncture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Anxiety secondary to lumbar puncture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Soreness at LP procedure site | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Headache post procedure | Injury, poisoning and procedural complications | Systematic Assessment |
|
| mild upper respiratory congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Headache post LP | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Migraine | Nervous system disorders | Systematic Assessment |
|
| Back pain secondary to lumbar puncture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Headache (localized to back of head) | Nervous system disorders | Systematic Assessment |
|
| Lightheaded | Nervous system disorders | Systematic Assessment |
|
| Weakness | General disorders | Systematic Assessment |
|
| Chills | General disorders | Systematic Assessment |
|
| Minor back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D001706 | Biopsy |
| D003943 | Diagnostic Techniques, Neurological |
| D013812 | Therapeutics |