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
• Status: Completed
• 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
• 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:

-

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

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)