TREAT-MS Trial Blinded Outcomes Assessments
The primary endpoint for the TREAT-MS Trial is the Expanded Disability Status Scale-plus (EDSS+) which combines the EDSS and two specific components of the Multiple Sclerosis Functional Composite (MSFC), the timed 25-foot walk test (T25FWT) and the nine hole peg test (9HPT).
Evaluations of the primary and some secondary endpoints will be performed by qualified personnel who are blinded to the study patient’s risk stratification, medication class and specific DMT chosen. Blinded EDSS examiners may be certified to complete the EDSS exams for the TREAT-MS trial if they have submitted a level A, B or C Neurostatus certificate for a previous/concurrent industry-sponsored trial or have documented experience performing the EDSS exam for an investigator-initiated trial.
Blinded coordinators (examining technician) will complete the MSFC, low contrast vision testing and the Symbol Digit Modalities Test (SDMT) for all study patients. For certification as a blinded coordinator for the TREAT-MS trial, the MSFC manual and training videos for the MSFC components, low contrast vision testing and the SDMT should be reviewed followed by the completion of an attestation form.
II. Watch the following five videos
- Timed 25-foot walk test
- Nine hole peg test
- Paced Auditory Serial Addition Test
- Low-contrast vision testing
- Symbol Digit Modalities Test
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