Study Describing Cognitive Processing Speed Changes in Relapsing Multiple Sclerosis Subjects Treated With Ozanimod (RPC-1063)
Public ClinicalTrials.gov record NCT04140305. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Longitudinal, Open-Label, Single-Arm Study Describing Cognitive Processing Speed Changes in Relapsing Multiple Sclerosis Subjects Treated With Ozanimod (RPC-1063)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04140305
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 188 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 16, 2020 (Actual)
- Primary completion
- May 15, 2025 (Actual)
- Completion
- May 15, 2025 (Actual)
- Last update posted
- Jun 12, 2025
2020 – 2025
United States locations
- U.S. sites
- 56
- U.S. states
- 27
- U.S. cities
- 52
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Local Institution - 123 | Birmingham | Alabama | 35209 | — |
| Local Institution - 136 | Cullman | Alabama | 35058 | — |
| Local Institution - 153 | Mobile | Alabama | 36617 | — |
| Local Institution - 162 | Phoenix | Arizona | 85018 | — |
| Local Institution - 128 | Pasadena | California | 91105 | — |
| Local Institution - 164 | Sacramento | California | 95817 | — |
| Local Institution - 107 | Aurora | Colorado | 80045 | — |
| Local Institution - 102 | Colorado Springs | Colorado | 80907 | — |
| Local Institution - 144 | Fort Collins | Colorado | 80528 | — |
| Local Institution - 109 | Washington D.C. | District of Columbia | 20007 | — |
| Local Institution - 140 | Boca Raton | Florida | 33428 | — |
| Local Institution - 158 | Vero Beach | Florida | 32960-4818 | — |
| Local Institution - 114 | Savannah | Georgia | 31406 | — |
| Northwest Neurology, Ltd | Hoffman Estates | Illinois | 60169 | — |
| Local Institution - 108 | Northbrook | Illinois | 60062 | — |
| Local Institution - 148 | Fort Wayne | Indiana | 46825-1603 | — |
| Local Institution - 126 | Ames | Iowa | 50010 | — |
| Local Institution - 173 | Kansas City | Kansas | 66160 | — |
| Local Institution - 133 | Alexandria | Louisiana | 71301 | — |
| Local Institution - 152 | Detroit | Michigan | 48201 | — |
| Local Institution - 112 | Detroit | Michigan | 48202 | — |
| Local Institution - 122 | St Louis | Missouri | 63110 | — |
| Local Institution - 143 | St Louis | Missouri | 63131 | — |
| Advanced Neurology Specialists | Great Falls | Montana | 59405 | — |
| Local Institution - 149 | Teaneck | New Jersey | 07666 | — |
| Dent Neurologic Institute | Amherst | New York | 14226 | — |
| Local Institution - 137 | Buffalo | New York | 14202 | — |
| Local Institution - 160 | East Setauket | New York | 11733-3528 | — |
| Local Institution - 130 | New York | New York | 10016 | — |
| Local Institution - 121 | New York | New York | 10021 | — |
| Local Institution - 146 | Patchogue | New York | 11772 | — |
| Local Institution - 131 | Chapel Hill | North Carolina | 27514 | — |
| Local Institution - 106 | Greensboro | North Carolina | 27405 | — |
| Local Institution - 170 | Mooresville | North Carolina | 28117 | — |
| Raleigh Neurology Associates PA | Raleigh | North Carolina | 27607 | — |
| Local Institution - 174 | Cincinnati | Ohio | 45219 | — |
| Local Institution - 171 | Cleveland | Ohio | 44106 | — |
| Local Institution - 142 | Dayton | Ohio | 45417 | — |
| Local Institution - 157 | Oklahoma City | Oklahoma | 73104 | — |
| Local Institution - 159 | Philadelphia | Pennsylvania | 19107 | — |
| Local Institution - 169 | Philadelphia | Pennsylvania | 19140 | — |
| University of Pittsburgh Medical Center Magee Womens Hospital | Pittsburgh | Pennsylvania | 15213 | — |
| Local Institution - 125 | Franklin | Tennessee | 37064 | — |
| Local Institution - 119 | Knoxville | Tennessee | 37922 | — |
| Local Institution - 139 | Dallas | Texas | 75246 | — |
| Local Institution - 113 | Round Rock | Texas | 78681 | — |
| Local Institution - 101 | San Antonio | Texas | 78259 | — |
| Local Institution - 103 | Norfolk | Virginia | 23502 | — |
| Local Institution - 141 | Kirkland | Washington | 98034 | — |
| Local Institution - 168 | Seattle | Washington | 98101 | — |
| Local Institution - 172 | Spokane | Washington | 99202 | — |
| Local Institution - 124 | Tacoma | Washington | 98405 | — |
| Local Institution - 156 | Huntington | West Virginia | 25701 | — |
| Local Institution - 150 | Morgantown | West Virginia | 26506 | — |
| Local Institution - 167 | Madison | Wisconsin | 53792 | — |
| Local Institution - 147 | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04140305, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 12, 2025 · Synced Oct 30, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04140305 live on ClinicalTrials.gov.