Relaxin in Multiple Sclerosis (MS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Providence Health & Services
Sponsor:
Collaborator:
Providence Brain & Spine Institute
Information provided by (Responsible Party):
Providence Health & Services
ClinicalTrials.gov Identifier:
NCT01909492
First received: July 24, 2013
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention
Multiple Sclerosis, Relapsing-Remitting
Procedure: Blood Draw
Procedure: Lumbar Puncture

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Measurement of Relaxin in the Serum and Cerebrospinal Fluid of Subjects With and Without the Relapsing Form of Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Providence Health & Services:

Primary Outcome Measures:
  • Relaxin (RLX) Levels [ Time Frame: During diagnostic LP ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples Without DNA

Patients will provide blood and cerebrospinal fluid for use in this research.


Estimated Enrollment: 30
Study Start Date: July 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Procedure: Blood Draw
Patients will provide a serum sample for research.
Procedure: Lumbar Puncture
Patients will have a lumbar puncture to obtain CSF.
Other Names:
  • Spinal tap
  • LP
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.
Procedure: Blood Draw
Patients will provide a serum sample for research.
Procedure: Lumbar Puncture
Patients will have a lumbar puncture to obtain CSF.
Other Names:
  • Spinal tap
  • LP
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.
Procedure: Blood Draw
Patients will provide a serum sample for research.
Procedure: Lumbar Puncture
Patients will have a lumbar puncture to obtain CSF.
Other Names:
  • Spinal tap
  • LP

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01909492

Locations
United States, Oregon
Providence MS Center Recruiting
Portland, Oregon, United States, 97225
Contact: Crystal Turner    503-216-1017    Crystal.Turner2@providence.org   
Contact: Chiayi Chen, RN, PhD    (503) 216-1012    Chiayi.Chen@providence.org   
Principal Investigator: Stanley Cohan, MD, PhD         
Sub-Investigator: Kiren Kresa-Reahl, MD         
Sub-Investigator: Hubert Leonard, MD         
Sub-Investigator: Harry Reahl, MD         
Sub-Investigator: Kyle Smoot, MD         
Sponsors and Collaborators
Providence Health & Services
Providence Brain & Spine Institute
Investigators
Principal Investigator: Stanley Cohan, MD, PhD Providence Brain & Spine Institute, Providence Health & Services
  More Information

No publications provided

Responsible Party: Providence Health & Services
ClinicalTrials.gov Identifier: NCT01909492     History of Changes
Other Study ID Numbers: 13-089B
Study First Received: July 24, 2013
Last Updated: April 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Providence Health & Services:
Multiple Sclerosis
MS
Relaxin

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 31, 2014