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An investigation of clinical outcome measures in PPMS to inform the design of investigator initiated clinical trials.








An investigation of clinical outcome measures in PPMS to inform the design of investigator initiated clinical trials.


Marcus Koch MD PhD


University of Calgary, Calgary, Alberta, Canada






30 Sep 2019


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.



[{ "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