Serial Collection of Primary Progressive Multiple Sclerosis Participants in the MURDOCK Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Duke University
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01776060
First received: January 23, 2013
Last updated: February 14, 2014
Last verified: February 2014
  Purpose

The goal of this study is to enroll 100 participants with Primary Progressive Multiple Sclerosis (PPMS) that have joined the MURDOCK Study Horizon 1.5 (Duke IRB Pro00011196) and the Multiple Sclerosis cohort (Duke IRB Pro00023791). All 100 participants will complete a biannual collection of a follow up questionnaire and blood/urine collection for a period of 5 years.


Condition Intervention
Primary Progressive Multiple Sclerosis
Other: generation of 'omic markers of disease progression

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Serial Collection of Primary Progressive Multiple Sclerosis Participants in the MURDOCK Study

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Generation of 'omic markers of disease progression [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Biannual collection of samples from PPMS patients would not only permit the identification of 'omic profiles that can be compared and contrasted to those from RRMS patients in a parallel study, but it would also allow the generation of 'omic markers of disease progression. This progressive etiology would provide valuable insight into PPMS development and may also shed light on SPMS progression.


Biospecimen Retention:   Samples With DNA

Blood (RNA/DNA), serum, plasma, urine


Estimated Enrollment: 100
Study Start Date: January 2013
Estimated Study Completion Date: February 2020
Estimated Primary Completion Date: February 2020 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: generation of 'omic markers of disease progression
    Aside from first in disease sampling, the serial, biannual collection of samples from PPMS patients would not only permit the identification of 'omic profiles that can be compared and contrasted to those from RRMS patients in a parallel study, but it would also allow the generation of 'omic markers of disease progression.
Detailed Description:

Unlike Relapsing Remitting Multiple Sclerosis (RRMS) or Secondary Progressive Multiple Sclerosis (SPMS) in which patients experience a remission or lessening of their symptoms, Primary Progressive Multiple Sclerosis (PPMS) is characterized by progression of disability from onset, with no, or only occasional and minor, remissions and improvements. The age of onset for the primary progressive subtype is later than for the relapsing-remitting, but similar to mean the age of progression between the relapsing-remitting and the secondary progressive - around 40 years of age. Because of its prevalence, RRMS represents the largest basis for basic and clinical MS research. Therefore, drugs have primarily been developed to slow disease progression in RRMS and SPMS patients. No treatment has been proven successful in treating primary progressive MS.

The MURDOCK-MS collection represents a unique opportunity to carry out detailed biomarker research on PPMS patients and, to the knowledge of this investigator and his colleagues in the field, would represent an exceptional cohort that is not available elsewhere in the US or the rest of the world. Aside from first in disease sampling, the serial, biannual collection of samples from PPMS patients would not only permit the identification of 'omic profiles that can be compared and contrasted to those from RRMS patients in a parallel study, but it would also allow the generation of 'omic markers of disease progression. This progressive etiology would provide valuable insight into PPMS development and may also shed light on SPMS progression.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Participants must enroll in the MURDOCK Study Horizon 1.5 (Pro00011196) as well as the Multiple Sclerosis cohort (Pro00023791) in order to participate in this biannual collection of a follow up questionnaire and blood/urine collection for participants who have Primary Progressive MS. The biannual collection will continue for 5 years. Those participants with PPMS who are already enrolled in the MURDOCK Study Horizon 1.5 and Multiple Sclerosis cohort will be contacted via phone to assess interest in the PPMS study. New participants with PPMS who enroll into the Horizon 1.5 study and Multiple Sclerosis cohort will be asked during the time of enrollment if they would like to participate in the PPMS study as well.

Criteria

Inclusion Criteria:

  • Enrolled in the MURDOCK Study Horizon 1.5 (Pro00011196)
  • Enrolled in the Multiple Sclerosis Cohort (Pro00023791)
  • Diagnosed with Primary Progressive Multiple Sclerosis
  • At least 18 years of age

Exclusion Criteria:

  • Participants not willing to participate or sign informed consent
  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: NCT01776060

Contacts
Contact: Kimberly Roseman 704-250-5861 kimberly.roseman@duke.edu
Contact: Sarah Maichle 919-695-6413 sarah.maichle@duke.edu

Locations
United States, North Carolina
MS Center Charlotte Recruiting
Charlotte, North Carolina, United States, 28207
Contact: Bridget Loven    704-446-1987    bridget.loven@carolinashealthcare.org   
Principal Investigator: Jill Conway, M.D.         
NE Neurology Recruiting
Concord, North Carolina, United States, 28025
Contact: Kimberly Roseman    704-250-5861    kimberly.roseman@duke.edu   
Contact: Leah Bouk    704-250-5861    leah.bouk@duke.edu   
Duke Center for Human Genetics Recruiting
Durham, North Carolina, United States, 27705
Contact: Sarah Maichle    919-695-6413    sarah.maichle@duke.edu   
Principal Investigator: Simon Gregory, PhD         
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Simon Gr, PhD Duke Medicine Site Based Research Group
  More Information

Additional Information:
No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01776060     History of Changes
Other Study ID Numbers: Pro00040961
Study First Received: January 23, 2013
Last Updated: February 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Primary Progressive Multiple Sclerosis
Multiple Sclerosis
biomarker
'omic
progression

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Chronic Progressive
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 August 25, 2014