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An investigation of clinical outcome measures in PPMS to inform the design of investigator initiated clinical trials.
Proposal
5995
Title of Proposed Research
An investigation of clinical outcome measures in PPMS to inform the design of investigator initiated clinical trials.
Lead Researcher
Marcus Koch MD PhD
Affiliation
University of Calgary, Calgary, Alberta, Canada
Funding Source
Potential Conflicts of Interest
Data Sharing Agreement Date
Lay Summary
Primary progressive multiple sclerosis (PPMS) is an incurable chronic neurological condition. Treatment trials in PPMS are difficult in part because there is no clarity about the most useful outcome measures and inclusion criteria. In the proposed research, we will determine rates of clinical worsening on a variety of outcome measures, which will help to select the most fitting primary outcome measure in investigator initiated trials.We will also investigate the relation of baseline characteristics of the study participants (such as sex, age, MRI characteristics at baseline) which the risk of worsening of disability throughout the duration of the trial. These analyses will help to select the most useful inclusion and exclusion criteria for investigator initiated trials in PPMS.
Study Data Provided
[{ "PostingID": 4594, "Title": "NOVARTIS-CFTY720D2306", "Description": "A Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5mg FTY720 Administered Orally Once Daily Versus Placebo in Patients With Primary Progressive Multiple Sclerosis" }]
Statistical Analysis Plan
Publication Citation
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