NCT01776060

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

January 23, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 25, 2013

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 21, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2020

Completed
Last Updated

May 21, 2024

Status Verified

May 1, 2024

Enrollment Period

7.7 years

First QC Date

January 23, 2013

Last Update Submit

May 20, 2024

Conditions

Keywords

Primary Progressive Multiple SclerosisMultiple Sclerosisbiomarker'omicprogression

Outcome Measures

Primary Outcomes (1)

  • Generation of 'omic markers of disease progression

    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.

    5 years

Interventions

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.

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Participants not willing to participate or sign informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

NE Neurology

Concord, North Carolina, 28025, United States

Location

The Stedman Center on the Duke Center for Living Campus

Durham, North Carolina, 27705, United States

Location

Raleigh Neurology Associates

Raleigh, North Carolina, 27607, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Multiple Sclerosis, Chronic ProgressiveMultiple SclerosisDisease Progression

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Simon Gr, PhD

    Duke Medicine Site Based Research Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2013

First Posted

January 25, 2013

Study Start

January 1, 2013

Primary Completion

September 21, 2020

Study Completion

September 21, 2020

Last Updated

May 21, 2024

Record last verified: 2024-05

Locations