Clinical trial NCT01776060: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Progressive Multiple Sclerosis
Keywords: Primary Progressive Multiple Sclerosis
Multiple Sclerosis
biomarker
'omic
progression
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2013-01-25
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.

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

Primary outcomes:
measure: Generation of 'omic markers of disease progression
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Concord
country: United States
facility: NE Neurology
state: North Carolina
city: Durham
country: United States
facility: The Stedman Center on the Duke Center for Living Campus
state: North Carolina
city: Raleigh
country: United States
facility: Raleigh Neurology Associates
state: North Carolina
Study officials:
affiliation: Duke Medicine Site Based Research Group
name: Simon Gr, PhD
role: PRINCIPAL_INVESTIGATOR
References: