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A Prospective Biomarker Study in Active SPMS Subjects Treated With Cladribine Tablets

Multiple Sclerosis Clinical Trial

Official title:
A Prospective Biomarker Study in Active Secondary Progressive Multiple Sclerosis (SPMS)Subjects Treated With Cladribine Tablets

Clinical Trial Summary

The purpose of this study is to explore the concept that biomarker sensitivity will detect activity in Multiple Sclerosis (MS) subjects and allow appropriate change in treatment to prevent dysfunction.

Clinical Trial Description

After being informed about the study and potential risks, all patients giving written informed consent will undergo a screening period. Maximum allowable time between first screening procedure and first administration of study treatment will be 42 days. Subjects will have a 28 day run-in period consisting of 2 visits at week -4 and week -2. Subjects will have a Baseline day 1 visit. Study medication will commerce on the day following this visit. Additional visits will be at the following time points: week 4, week 8, week 12, week 16, week 24, week 36, week 48, week 52, week 56, week 60, week 72, week 84 and week 96. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04550455
Study type Interventional
Source Multiple Sclerosis Center of Northeastern New York
Contact Judy Button
Phone 518-785-1000
Email jbutton@tristateneuro.com
Status Recruiting
Phase Phase 4
Start date September 16, 2020
Completion date December 2025
View Details
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