Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 35 of 39 for:    idiopathic intracranial hypertension

Relaxin in Multiple Sclerosis (MS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01909492
Recruitment Status : Recruiting
First Posted : July 26, 2013
Last Update Posted : October 10, 2018
Sponsor:
Collaborator:
Providence Brain & Spine Institute; Microstein, LLC
Information provided by (Responsible Party):
Providence Health & Services

Tracking Information
First Submitted Date July 24, 2013
First Posted Date July 26, 2013
Last Update Posted Date October 10, 2018
Actual Study Start Date September 20, 2013
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 24, 2013)
Relaxin (RLX) Levels [ Time Frame: 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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01909492 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 8, 2018)
Sema4A levels [ Time Frame: During diagnostic LP ]
Evaluation of sema 4A levels during acute inflammatory and stable patients with relapsing form of MS
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Relaxin in Multiple Sclerosis (MS)
Official Title Measurement of Relaxin in the Serum and Cerebrospinal Fluid of Subjects With and Without the Relapsing Form of Multiple Sclerosis
Brief Summary This study will evaluate relaxin (RLX) and Semaphorin 4A (Sema4A) 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 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.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Patients will provide blood and cerebrospinal fluid for use in this research.
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.
Condition Multiple Sclerosis, Relapsing-Remitting
Intervention
  • 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
Study Groups/Cohorts
  • 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.
    Interventions:
    • Procedure: Blood Draw
    • Procedure: 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.
    Interventions:
    • Procedure: Blood Draw
    • Procedure: 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.
    Interventions:
    • Procedure: Blood Draw
    • Procedure: Lumbar Puncture
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 24, 2013)
30
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2020
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility 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

Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Hannah Voss 503-216-1193 hannah.voss@providence.org
Contact: Chiayi Chen, PhD (503) 216-1012 Chiayi.Chen@providence.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01909492
Other Study ID Numbers 13-089B
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Providence Health & Services
Study Sponsor Providence Health & Services
Collaborators Providence Brain & Spine Institute; Microstein, LLC
Investigators
Principal Investigator: Stanley Cohan, MD, PhD Providence Brain & Spine Institute, Providence Health & Services
PRS Account Providence Health & Services
Verification Date October 2018