Trial Outcomes & Findings for Measurement of Relaxin Peptide in Multiple Sclerosis (MS) (NCT NCT01909492)
NCT ID: NCT01909492
Last Updated: 2025-06-22
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
30 participants
Primary outcome timeframe
During diagnostic LP
Results posted on
2025-06-22
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Measurement of Relaxin Peptide in Multiple Sclerosis (MS)
Baseline characteristics by cohort
| Measure |
Group 1
n=10 Participants
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.
|
Group 2
n=10 Participants
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.
|
Group 3
n=10 Participants
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.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
30 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
30 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
27 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=99 Participants
|
10 participants
n=107 Participants
|
10 participants
n=206 Participants
|
30 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: During 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.
Outcome measures
| Measure |
Group 1
n=10 Participants
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.
|
Group 2
n=10 Participants
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.
|
Group 3
n=10 Participants
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.
|
|---|---|---|---|
|
Relaxin (RLX) Levels
RLX2 concentration level solely in serum
|
NA pmol/mL
Serum and CSF samples obtained from all of the volunteers, with or without a diagnosis of MS, failed to reveal RLX2 measurable above or equal to the LLD for the employed assay.
|
NA pmol/mL
Serum and CSF samples obtained from all of the volunteers, with or without a diagnosis of MS, failed to reveal RLX2 measurable above or equal to the LLD for the employed assay.
|
NA pmol/mL
Serum and CSF samples obtained from all of the volunteers, with or without a diagnosis of MS, failed to reveal RLX2 measurable above or equal to the LLD for the employed assay.
|
|
Relaxin (RLX) Levels
RLX2 concentration level solely in the CSF
|
NA pmol/mL
Serum and CSF samples obtained from all of the volunteers, with or without a diagnosis of MS, failed to reveal RLX2 measurable above or equal to the LLD for the employed assay.
|
NA pmol/mL
Serum and CSF samples obtained from all of the volunteers, with or without a diagnosis of MS, failed to reveal RLX2 measurable above or equal to the LLD for the employed assay.
|
NA pmol/mL
Serum and CSF samples obtained from all of the volunteers, with or without a diagnosis of MS, failed to reveal RLX2 measurable above or equal to the LLD for the employed assay.
|
Adverse Events
Group 1
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Group 2
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Group 3
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1
n=10 participants at risk
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.
|
Group 2
n=10 participants at risk
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.
|
Group 3
n=10 participants at risk
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.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Soreness at LP procedure site
|
0.00%
0/10 • Approximately 24 hours after the LP procedure research staff will contact the patient by phone to discuss any symptoms or serious adverse events
|
10.0%
1/10 • Number of events 1 • Approximately 24 hours after the LP procedure research staff will contact the patient by phone to discuss any symptoms or serious adverse events
|
0.00%
0/10 • Approximately 24 hours after the LP procedure research staff will contact the patient by phone to discuss any symptoms or serious adverse events
|
|
Injury, poisoning and procedural complications
Headache post procedure
|
0.00%
0/10 • Approximately 24 hours after the LP procedure research staff will contact the patient by phone to discuss any symptoms or serious adverse events
|
10.0%
1/10 • Number of events 1 • Approximately 24 hours after the LP procedure research staff will contact the patient by phone to discuss any symptoms or serious adverse events
|
0.00%
0/10 • Approximately 24 hours after the LP procedure research staff will contact the patient by phone to discuss any symptoms or serious adverse events
|
|
Musculoskeletal and connective tissue disorders
Generalized soreness
|
10.0%
1/10 • Number of events 1 • Approximately 24 hours after the LP procedure research staff will contact the patient by phone to discuss any symptoms or serious adverse events
|
0.00%
0/10 • Approximately 24 hours after the LP procedure research staff will contact the patient by phone to discuss any symptoms or serious adverse events
|
0.00%
0/10 • Approximately 24 hours after the LP procedure research staff will contact the patient by phone to discuss any symptoms or serious adverse events
|
|
Nervous system disorders
Headache/Headaches
|
30.0%
3/10 • Number of events 3 • Approximately 24 hours after the LP procedure research staff will contact the patient by phone to discuss any symptoms or serious adverse events
|
30.0%
3/10 • Number of events 3 • Approximately 24 hours after the LP procedure research staff will contact the patient by phone to discuss any symptoms or serious adverse events
|
20.0%
2/10 • Number of events 2 • Approximately 24 hours after the LP procedure research staff will contact the patient by phone to discuss any symptoms or serious adverse events
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
1/10 • Number of events 1 • Approximately 24 hours after the LP procedure research staff will contact the patient by phone to discuss any symptoms or serious adverse events
|
0.00%
0/10 • Approximately 24 hours after the LP procedure research staff will contact the patient by phone to discuss any symptoms or serious adverse events
|
30.0%
3/10 • Number of events 3 • Approximately 24 hours after the LP procedure research staff will contact the patient by phone to discuss any symptoms or serious adverse events
|
|
Musculoskeletal and connective tissue disorders
Low back pain
|
10.0%
1/10 • Number of events 1 • Approximately 24 hours after the LP procedure research staff will contact the patient by phone to discuss any symptoms or serious adverse events
|
0.00%
0/10 • Approximately 24 hours after the LP procedure research staff will contact the patient by phone to discuss any symptoms or serious adverse events
|
0.00%
0/10 • Approximately 24 hours after the LP procedure research staff will contact the patient by phone to discuss any symptoms or serious adverse events
|
|
Musculoskeletal and connective tissue disorders
Back soreness
|
10.0%
1/10 • Number of events 1 • Approximately 24 hours after the LP procedure research staff will contact the patient by phone to discuss any symptoms or serious adverse events
|
0.00%
0/10 • Approximately 24 hours after the LP procedure research staff will contact the patient by phone to discuss any symptoms or serious adverse events
|
0.00%
0/10 • Approximately 24 hours after the LP procedure research staff will contact the patient by phone to discuss any symptoms or serious adverse events
|
|
Musculoskeletal and connective tissue disorders
Low back tenderness
|
0.00%
0/10 • Approximately 24 hours after the LP procedure research staff will contact the patient by phone to discuss any symptoms or serious adverse events
|
10.0%
1/10 • Number of events 1 • Approximately 24 hours after the LP procedure research staff will contact the patient by phone to discuss any symptoms or serious adverse events
|
0.00%
0/10 • Approximately 24 hours after the LP procedure research staff will contact the patient by phone to discuss any symptoms or serious adverse events
|
|
Musculoskeletal and connective tissue disorders
Back ache
|
0.00%
0/10 • Approximately 24 hours after the LP procedure research staff will contact the patient by phone to discuss any symptoms or serious adverse events
|
10.0%
1/10 • Number of events 1 • Approximately 24 hours after the LP procedure research staff will contact the patient by phone to discuss any symptoms or serious adverse events
|
0.00%
0/10 • Approximately 24 hours after the LP procedure research staff will contact the patient by phone to discuss any symptoms or serious adverse events
|
|
Injury, poisoning and procedural complications
Headache secondary to lumbar puncture
|
0.00%
0/10 • Approximately 24 hours after the LP procedure research staff will contact the patient by phone to discuss any symptoms or serious adverse events
|
10.0%
1/10 • Number of events 1 • Approximately 24 hours after the LP procedure research staff will contact the patient by phone to discuss any symptoms or serious adverse events
|
0.00%
0/10 • Approximately 24 hours after the LP procedure research staff will contact the patient by phone to discuss any symptoms or serious adverse events
|
|
Injury, poisoning and procedural complications
Anxiety secondary to lumbar puncture
|
0.00%
0/10 • Approximately 24 hours after the LP procedure research staff will contact the patient by phone to discuss any symptoms or serious adverse events
|
10.0%
1/10 • Number of events 1 • Approximately 24 hours after the LP procedure research staff will contact the patient by phone to discuss any symptoms or serious adverse events
|
0.00%
0/10 • Approximately 24 hours after the LP procedure research staff will contact the patient by phone to discuss any symptoms or serious adverse events
|
|
Respiratory, thoracic and mediastinal disorders
mild upper respiratory congestion
|
0.00%
0/10 • Approximately 24 hours after the LP procedure research staff will contact the patient by phone to discuss any symptoms or serious adverse events
|
0.00%
0/10 • Approximately 24 hours after the LP procedure research staff will contact the patient by phone to discuss any symptoms or serious adverse events
|
10.0%
1/10 • Number of events 1 • Approximately 24 hours after the LP procedure research staff will contact the patient by phone to discuss any symptoms or serious adverse events
|
|
Injury, poisoning and procedural complications
Headache post LP
|
0.00%
0/10 • Approximately 24 hours after the LP procedure research staff will contact the patient by phone to discuss any symptoms or serious adverse events
|
0.00%
0/10 • Approximately 24 hours after the LP procedure research staff will contact the patient by phone to discuss any symptoms or serious adverse events
|
10.0%
1/10 • Number of events 1 • Approximately 24 hours after the LP procedure research staff will contact the patient by phone to discuss any symptoms or serious adverse events
|
|
Nervous system disorders
Migraine
|
0.00%
0/10 • Approximately 24 hours after the LP procedure research staff will contact the patient by phone to discuss any symptoms or serious adverse events
|
0.00%
0/10 • Approximately 24 hours after the LP procedure research staff will contact the patient by phone to discuss any symptoms or serious adverse events
|
10.0%
1/10 • Number of events 1 • Approximately 24 hours after the LP procedure research staff will contact the patient by phone to discuss any symptoms or serious adverse events
|
|
Injury, poisoning and procedural complications
Back pain secondary to lumbar puncture
|
0.00%
0/10 • Approximately 24 hours after the LP procedure research staff will contact the patient by phone to discuss any symptoms or serious adverse events
|
0.00%
0/10 • Approximately 24 hours after the LP procedure research staff will contact the patient by phone to discuss any symptoms or serious adverse events
|
10.0%
1/10 • Number of events 1 • Approximately 24 hours after the LP procedure research staff will contact the patient by phone to discuss any symptoms or serious adverse events
|
|
Nervous system disorders
Headache (localized to back of head)
|
0.00%
0/10 • Approximately 24 hours after the LP procedure research staff will contact the patient by phone to discuss any symptoms or serious adverse events
|
0.00%
0/10 • Approximately 24 hours after the LP procedure research staff will contact the patient by phone to discuss any symptoms or serious adverse events
|
10.0%
1/10 • Number of events 1 • Approximately 24 hours after the LP procedure research staff will contact the patient by phone to discuss any symptoms or serious adverse events
|
|
Nervous system disorders
Lightheaded
|
0.00%
0/10 • Approximately 24 hours after the LP procedure research staff will contact the patient by phone to discuss any symptoms or serious adverse events
|
0.00%
0/10 • Approximately 24 hours after the LP procedure research staff will contact the patient by phone to discuss any symptoms or serious adverse events
|
10.0%
1/10 • Number of events 1 • Approximately 24 hours after the LP procedure research staff will contact the patient by phone to discuss any symptoms or serious adverse events
|
|
General disorders
Weakness
|
0.00%
0/10 • Approximately 24 hours after the LP procedure research staff will contact the patient by phone to discuss any symptoms or serious adverse events
|
0.00%
0/10 • Approximately 24 hours after the LP procedure research staff will contact the patient by phone to discuss any symptoms or serious adverse events
|
10.0%
1/10 • Number of events 1 • Approximately 24 hours after the LP procedure research staff will contact the patient by phone to discuss any symptoms or serious adverse events
|
|
General disorders
Chills
|
0.00%
0/10 • Approximately 24 hours after the LP procedure research staff will contact the patient by phone to discuss any symptoms or serious adverse events
|
0.00%
0/10 • Approximately 24 hours after the LP procedure research staff will contact the patient by phone to discuss any symptoms or serious adverse events
|
10.0%
1/10 • Number of events 1 • Approximately 24 hours after the LP procedure research staff will contact the patient by phone to discuss any symptoms or serious adverse events
|
|
Musculoskeletal and connective tissue disorders
Minor back pain
|
0.00%
0/10 • Approximately 24 hours after the LP procedure research staff will contact the patient by phone to discuss any symptoms or serious adverse events
|
0.00%
0/10 • Approximately 24 hours after the LP procedure research staff will contact the patient by phone to discuss any symptoms or serious adverse events
|
10.0%
1/10 • Number of events 1 • Approximately 24 hours after the LP procedure research staff will contact the patient by phone to discuss any symptoms or serious adverse events
|
Additional Information
Director of PBSI /WC Clinical Research Program
Providence Health & Services
Phone: (503) 216-1012
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place