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Measurement of Relaxin Peptide in Multiple Sclerosis (MS)

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Providence Health & Services

Status

Completed

Conditions

Multiple Sclerosis, Relapsing-Remitting

Treatments

Procedure: Lumbar Puncture
Procedure: Blood Draw

Study type

Observational

Funder types

Other

Identifiers

NCT01909492
13-089B

Details and patient eligibility

About

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

Full 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.

Enrollment

30 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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

Trial design

30 participants in 3 patient groups

Group 1
Description:
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.
Treatment:
Procedure: Blood Draw
Procedure: Lumbar Puncture
Group 2
Description:
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.
Treatment:
Procedure: Blood Draw
Procedure: Lumbar Puncture
Group 3
Description:
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.
Treatment:
Procedure: Blood Draw
Procedure: Lumbar Puncture

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Hannah Voss; Chiayi Chen, PhD

Data sourced from clinicaltrials.gov

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