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NCT02301572 Clinical Trial

Aggressive Onset Multiple Sclerosis: A Practical Definition and Study of Its Clinical Course

Multiple Sclerosis Clinical Trial

Official title:
Aggressive Onset Multiple Sclerosis: A Practical Definition and Study of Its Clinical Course

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02301572
Other study ID # 0711009544
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 2014
Est. completion date August 2016

Study information
Verified date September 2016
Source Weill Medical College of Cornell University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Chart review.

Description:

A chart review will be completed on patients with multiple sclerosis to determine potential early characteristics that might be helpful in defining aggressive onset MS and predicting subsequent disease course and disability

Recruitment information / eligibility
Status Completed
Enrollment 750
Est. completion date August 2016
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender All
Age group 0 Years to 89 Years
Eligibility Inclusion Criteria: - Two or more relapses in the preceding year and 2 or more gadolinium enhancing lesions on brain MRI scan or a significant T 2 lesion burden or - One relapse if it results in sustained EDSS of 3.0 along with 2 or more gadolinium enhancing lesions or significant T2 lesion burden ( T2 lesion burden being determined by factoring the number of lesions, the size of the lesions and lesion location) Exclusion Criteria: -

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Weill Cornell Medical College New York New York

Sponsors (2)
Lead Sponsor Collaborator
Weill Medical College of Cornell University Genzyme, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Disability outcome will be determined based on EDDS. Disability outcomes will be determined based on EDDS at last visit. EDSS at last follow up will be compared to EDSS at start of respective therapies and grouped into 3 categories: EDSS improved, EDSS no change and EDSS worsened. Multivariate logistic regression will be used to test individual variables that could potentially influence the outcome, including treatment, age at onset, gender and race. at the last visit (average time frame from baseline to last follow up visit expected to be 36 months)
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