Multiple Sclerosis Clinical Trial

Study Describing Cognitive Processing Speed Changes in Relapsing Multiple Sclerosis Subjects Treated With Ozanimod (RPC-1063)

Summary

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 ≥ 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 (± 15 days) and a 90-day (± 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 ≤ 1 DMT, have an EDSS ≤ 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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).

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

250

Study ID:

NCT04140305

Recruitment Status:

Active, not recruiting

Sponsor:

Celgene

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There are 61 Locations for this study

See Locations Near You

Local Institution - 123
Birmingham Alabama, 35209, United States
Local Institution - 136
Cullman Alabama, 35058, United States
Local Institution - 153
Mobile Alabama, 36617, United States
Local Institution - 162
Phoenix Arizona, 85018, United States
Local Institution - 128
Pasadena California, 91105, United States
Local Institution - 164
Sacramento California, 95817, United States
Local Institution - 107
Aurora Colorado, 80045, United States
Local Institution - 102
Colorado Springs Colorado, 80907, United States
Local Institution - 144
Fort Collins Colorado, 80528, United States
Local Institution - 109
Washington District of Columbia, 20007, United States
Local Institution - 140
Boca Raton Florida, 33428, United States
Local Institution - 158
Vero Beach Florida, 32960, United States
Local Institution - 114
Savannah Georgia, 31406, United States
Northwest Neurology, Ltd
Hoffman Estates Illinois, 60169, United States
Local Institution - 108
Northbrook Illinois, 60062, United States
Local Institution - 148
Fort Wayne Indiana, 46825, United States
Local Institution - 126
Ames Iowa, 50010, United States
Local Institution - 173
Kansas City Kansas, 66160, United States
Local Institution - 133
Alexandria Louisiana, 71301, United States
Local Institution - 152
Detroit Michigan, 48201, United States
Local Institution - 112
Detroit Michigan, 48202, United States
Local Institution - 122
Saint Louis Missouri, 63110, United States
Local Institution - 143
Saint Louis Missouri, 63131, United States
Advanced Neurology Specialists
Great Falls Montana, 59405, United States
Local Institution - 149
Teaneck New Jersey, 07666, United States
Dent Neurologic Institute
Amherst New York, 14226, United States
Local Institution - 137
Buffalo New York, 14202, United States
Local Institution - 160
East Setauket New York, 11733, United States
Local Institution - 130
New York New York, 10016, United States
Local Institution - 121
New York New York, 10021, United States
Local Institution - 146
Patchogue New York, 11772, United States
Local Institution - 131
Chapel Hill North Carolina, 27514, United States
Local Institution - 106
Greensboro North Carolina, 27405, United States
Local Institution - 170
Mooresville North Carolina, 28117, United States
Raleigh Neurology Associates PA
Raleigh North Carolina, 27607, United States
Local Institution - 174
Cincinnati Ohio, 45219, United States
Local Institution - 171
Cleveland Ohio, 44106, United States
UC Health, LLC
Dayton Ohio, 45417, United States
Local Institution - 157
Oklahoma City Oklahoma, 73104, United States
Local Institution - 159
Philadelphia Pennsylvania, 19107, United States
Local Institution - 169
Philadelphia Pennsylvania, 19140, United States
University of Pittsburgh Medical Center Magee Womens Hospital
Pittsburgh Pennsylvania, 15213, United States
Local Institution - 125
Franklin Tennessee, 37064, United States
Local Institution - 119
Knoxville Tennessee, 37922, United States
Baylor Research Institute - Dallas Clinical Trials Office
Dallas Texas, 75246, United States
Local Institution - 113
Round Rock Texas, 78681, United States
Local Institution - 101
San Antonio Texas, 78259, United States
Local Institution - 103
Norfolk Virginia, 23502, United States
Local Institution - 141
Kirkland Washington, 98034, United States
Local Institution - 168
Seattle Washington, 98101, United States
Local Institution - 172
Spokane Washington, 99202, United States
Local Institution - 124
Tacoma Washington, 98405, United States
Local Institution - 156
Huntington West Virginia, 25701, United States
Local Institution - 150
Morgantown West Virginia, 26506, United States
Local Institution - 167
Madison Wisconsin, 53792, United States
Local Institution - 147
Milwaukee Wisconsin, 53226, United States
Local Institution - 203
London Ontario, N6G 2, Canada
Local Institution - 204
Ottawa Ontario, K1H 8, Canada
Local Institution - 206
Montreal Quebec, H2X 0, Canada
Local Institution - 207
Halifax , B3R 1, Canada
Local Institution - 166
Guaynabo , 00968, Puerto Rico

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

250

Study ID:

NCT04140305

Recruitment Status:

Active, not recruiting

Sponsor:


Celgene

How clear is this clinincal trial information?

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