Relaxin in Multiple Sclerosis (MS)
Last updated on April 2022Recruitment
- Recruitment Status
- Recruiting
Inclusion Criteria
- 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.
- 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 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 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.
- 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 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.
Summary
- Conditions
- Multiple Sclerosis - Relapsing Remitting
- Multiple Sclerosis, Relapsing-Remitting
- Type
- Observational
- Design
- Observational Model: Case-Control
- Time Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 45 years
- Gender
- Only females
Description
The goal of this study is to obtain baseline information on serum and cerebrospinal fluid (CSF) relaxin and Sema4A 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, and further characterize the role of S...
The goal of this study is to obtain baseline information on serum and cerebrospinal fluid (CSF) relaxin and Sema4A 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, and further characterize the role of Sema4A in MS patients.
Inclusion Criteria
- 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.
- 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 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 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.
- 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 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.
Tracking Information
- NCT #
- NCT01909492
- Collaborators
- Providence Brain & Spine Institute; Microstein, LLC
- Microstein, LLC
- Investigators
- Principal Investigator: Stanley Cohan, MD, PhD Providence Brain & Spine Institute, Providence Health & Services
- Stanley Cohan, MD, PhD Providence Brain & Spine Institute, Providence Health & Services