Multiple Sclerosis Clinical Trial
Study Describing Cognitive Processing Speed Changes in Relapsing Multiple Sclerosis Subjects Treated With Ozanimod (RPC-1063)
This is a multicenter, longitudinal, single-arm, open-label study to describe the change from baseline in cognitive processing speed, measured by the SDMT, in subjects with RMS treated with ozanimod HCl 1 mg at 3 years.
All subjects will receive orally administered ozanimod HCl 1 mg. The primary efficacy endpoint is the proportion of subjects with a clinically meaningful increase in raw score of â‰¥ 4 points or 10% from baseline (improved). The treatment period is 36 months. For all subjects who finish the subject and for those who discontinue, there will be a 30-day (Â± 15 days) and a 90-day (Â± 10 days) Safety Follow-up Visit. There is no planned protocol extension following the end of the study. Approximately 250 subjects with RMS will be recruited for this study.
Subjects with RMS will be enrolled in this study if they have received â‰¤ 1 DMT, have an EDSS â‰¤ 3.5, and have been diagnosed with RMS within 5 years of study entry. The Investigator will be responsible for the overall conduct of the study at the site, confirmation of subject eligibility, routine study subject clinical management including for MS relapses, and management of AEs.
Below are some criteria for inclusion. Additional Inclusion criteria apply.
Subject must understand and voluntarily sign an informed consent form (ICF) prior to any study-related assessments/procedures being conducted.
Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
Subject is male or female 18 to 65 years of age (inclusive) at the time of signing of the ICF.
Subject has a diagnosis of MS according to the 2010 or 2017 Revised McDonald criteria.
Subjects has ≤ 5 years since time of RMS diagnosis.
Subject has ≤ 1 approved RMS DMT at time of study entry.
Following are some criteria that would exclude the subject from participation. Additional exclusion criteria apply.
Exclusions Related to General Health
Subject has any clinically relevant hepatic, neurological, pulmonary, ophthalmological, endocrine, psychiatric, or other major systemic disease making implementation of the protocol or interpretation of the study difficult or that would put the subject at risk by participating in the study. Subjects with mild or moderate asthma, and subjects with other mild pulmonary disease (eg, chronic obstructive pulmonary disease [COPD]) may be included in the study.
Subject has a presence of other neurologic disorders to explain the progressive neurologic disability (as defined in the key inclusion criteria) or that might affect cognition.
Subject has a visual or other sensorimotor impairment likely to confound test performance.
Subject has a presence of > 10 GdE lesions on the Baseline brain MRI scan.
Subject has a history of developmental disorder (eg, attention-deficit/hyperactivity disorder [ADHD], learning disability).
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There are 61 Locations for this study
Birmingham Alabama, 35209, United States
Cullman Alabama, 35058, United States
Mobile Alabama, 36617, United States
Phoenix Arizona, 85018, United States
Pasadena California, 91105, United States
Sacramento California, 95817, United States
Aurora Colorado, 80045, United States
Colorado Springs Colorado, 80907, United States
Fort Collins Colorado, 80528, United States
Washington District of Columbia, 20007, United States
Boca Raton Florida, 33428, United States
Vero Beach Florida, 32960, United States
Savannah Georgia, 31406, United States
Hoffman Estates Illinois, 60169, United States
Northbrook Illinois, 60062, United States
Fort Wayne Indiana, 46825, United States
Ames Iowa, 50010, United States
Kansas City Kansas, 66160, United States
Alexandria Louisiana, 71301, United States
Detroit Michigan, 48201, United States
Detroit Michigan, 48202, United States
Saint Louis Missouri, 63110, United States
Saint Louis Missouri, 63131, United States
Great Falls Montana, 59405, United States
Teaneck New Jersey, 07666, United States
Amherst New York, 14226, United States
Buffalo New York, 14202, United States
East Setauket New York, 11733, United States
New York New York, 10016, United States
New York New York, 10021, United States
Patchogue New York, 11772, United States
Chapel Hill North Carolina, 27514, United States
Greensboro North Carolina, 27405, United States
Mooresville North Carolina, 28117, United States
Raleigh North Carolina, 27607, United States
Cincinnati Ohio, 45219, United States
Cleveland Ohio, 44106, United States
Dayton Ohio, 45417, United States
Oklahoma City Oklahoma, 73104, United States
Philadelphia Pennsylvania, 19107, United States
Philadelphia Pennsylvania, 19140, United States
Pittsburgh Pennsylvania, 15213, United States
Franklin Tennessee, 37064, United States
Knoxville Tennessee, 37922, United States
Dallas Texas, 75246, United States
Round Rock Texas, 78681, United States
San Antonio Texas, 78259, United States
Norfolk Virginia, 23502, United States
Kirkland Washington, 98034, United States
Seattle Washington, 98101, United States
Spokane Washington, 99202, United States
Tacoma Washington, 98405, United States
Huntington West Virginia, 25701, United States
Morgantown West Virginia, 26506, United States
Madison Wisconsin, 53792, United States
Milwaukee Wisconsin, 53226, United States
London Ontario, N6G 2, Canada
Ottawa Ontario, K1H 8, Canada
Montreal Quebec, H2X 0, Canada
Halifax , B3R 1, Canada
Guaynabo , 00968, Puerto Rico
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