Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01776060
Recruitment Status : Active, not recruiting
First Posted : January 25, 2013
Last Update Posted : January 30, 2020
Sponsor:
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date January 23, 2013
First Posted Date January 25, 2013
Last Update Posted Date January 30, 2020
Actual Study Start Date January 2013
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 23, 2013)
Generation of 'omic markers of disease progression [ Time Frame: 5 years ]
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
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 Serial Collection of Primary Progressive Multiple Sclerosis Participants in the MURDOCK Study
Official Title Serial Collection of Primary Progressive Multiple Sclerosis Participants in the MURDOCK Study
Brief Summary 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.
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood (RNA/DNA), serum, plasma, urine
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.
Condition Primary Progressive Multiple Sclerosis
Intervention 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.
Study Groups/Cohorts Not Provided
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 Active, not recruiting
Estimated Enrollment
 (submitted: January 23, 2013)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01776060
Other Study ID Numbers Pro00040961
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Duke University
Study Sponsor Duke University
Collaborators Not Provided
Investigators
Principal Investigator: Simon Gr, PhD Duke Medicine Site Based Research Group
PRS Account Duke University
Verification Date January 2020