Nonrelapsing Secondary Progressive Multiple Sclerosis (NRSPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (HERCULES)
Public ClinicalTrials.gov record NCT04411641. 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 Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing SAR442168 to Placebo in Participants With Nonrelapsing Secondary Progressive Multiple Sclerosis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Primary Objective: To determine the efficacy of SAR442168 compared to placebo in delaying disability progression in NRSPMS Secondary Objective: To evaluate efficacy of SAR442168 compared to placebo on clinical endpoints, magnetic resonance imaging (MRI) lesions, cognitive performance, physical function, and quality of life To evaluate safety and tolerability of SAR442168 To evaluate population pharmacokinetics (PK) of SAR442168 and relevant metabolites in NRSPMS and its relationship to efficacy and safety To evaluate pharmacodynamics (PD) of SAR442168
Study identification
- NCT ID
- NCT04411641
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,131 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years to 60 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
- Sep 24, 2020 (Actual)
- Primary completion
- Aug 29, 2024 (Actual)
- Completion
- Aug 29, 2024 (Actual)
- Last update posted
- Jul 2, 2025
2020 – 2024
United States locations
- U.S. sites
- 51
- U.S. states
- 27
- U.S. cities
- 47
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama MS Center-Site Number:8400013 | Birmingham | Alabama | 35233 | — |
| Center for Neurology and Spine-Site Number:8400089 | Phoenix | Arizona | 84018 | — |
| Arcadia Neurology Center-Site Number:8400070 | Arcadia | California | 91006 | — |
| UC San Diego ACTRI-Site Number:8400101 | La Jolla | California | 92037 | — |
| Collaborative Neuroscience Research-Site Number:8400045 | Long Beach | California | 90806 | — |
| Multiple Sclerosis Center-Site Number:8400143 | Los Angeles | California | 90033 | — |
| University of San Francisco, Sandler Neurosciences Center-Site Number:8400137 | San Francisco | California | 94158 | — |
| Harbor UCLA-Site Number:8400088 | Torrance | California | 90502 | — |
| Regina Berkovich, MD, PhD-Site Number:8400059 | West Hollywood | California | 90048 | — |
| Mountain Neurological Research Center, Inc.-Site Number:8400128 | Basalt | Colorado | 81621 | — |
| University of Colorado-Site Number:8400012 | Denver | Colorado | 80262 | — |
| Advanced Neurosciences Research-Site Number:8400025 | Fort Collins | Colorado | 80528 | — |
| South Florida Neurology Associates-Site Number:8400029 | Boca Raton | Florida | 33487 | — |
| Neurology Associates, PA-Site Number:8400004 | Maitland | Florida | 32761 | — |
| Aqualane Clinical Research-Site Number:8400027 | Naples | Florida | 34105 | — |
| Axiom Clinical Research of Florida-Site Number:8400001 | Tampa | Florida | 33609-4052 | — |
| University of South Florida-Site Number:8400006 | Tampa | Florida | 33612 | — |
| Meridian Clinical Research-Site Number:8400003 | Savannah | Georgia | 31406 | — |
| Consultants In Neurology-Site Number:8400011 | Northbrook | Illinois | 60062 | — |
| University of Kansas Medical Center-Site Number:8400023 | Kansas City | Kansas | 66160-7321 | — |
| CHI Saint Joseph Medical Group Neurology-Site Number:8400110 | Lexington | Kentucky | 40509 | — |
| Tufts Medical Center-Site Number:8400072 | Boston | Massachusetts | 02111 | — |
| University of Massachusetts-Site Number:8400014 | Worcester | Massachusetts | 01655 | — |
| Wayne State University-Site Number:8400046 | Detroit | Michigan | 48201 | — |
| The Memorial Hospital-Site Number:8400033 | Owosso | Michigan | 48867 | — |
| Minneapolis Clinic of Neurology-Site Number:8400051 | Minneapolis | Minnesota | 55422 | — |
| Mayo Clinic-Site Number:8400111 | Rochester | Minnesota | 55905 | — |
| Missouri Baptist Medical Center-Site Number:8400019 | St Louis | Missouri | 63131 | — |
| Lou Ruvo Center for Brain Health-Site Number:8400117 | Las Vegas | Nevada | 89106 | — |
| Holy Name Hospital-Site Number:8400104 | Teaneck | New Jersey | 07666 | — |
| University of New Mexico-Site Number:8400032 | Albuquerque | New Mexico | 87131 | — |
| Icahn School of Medicine at Mount Sinai (Department of Endoc-Site Number:8400038 | New York | New York | 10029-6501 | — |
| Neurology Associates of Stony Brook-Site Number:8400042 | Stony Brook | New York | 11794 | — |
| Meridian Clinical Research, LLC-Site Number:8400005 | Raleigh | North Carolina | 27607 | — |
| Sanford Brain & Spine Center-Site Number:8400126 | Fargo | North Dakota | 58103 | — |
| University Hospitals CMC-Site Number:8400083 | Cleveland | Ohio | 44106 | — |
| Cleveland Clinic-Site Number:8400125 | Cleveland | Ohio | 44195 | — |
| Optimed Research, LTD-Site Number:8400147 | Columbus | Ohio | 43235 | — |
| Neurology Specialists-Site Number:8400002 | Dayton | Ohio | 45417 | — |
| Columbus Neuroscience-Site Number:8400010 | Westerville | Ohio | 40382 | — |
| Providence Multiple Sclerosis Center-Site Number:8400020 | Portland | Oregon | 97225 | — |
| Perelman Center for Advanced Medicine-Site Number:8400142 | Philadelphia | Pennsylvania | 19104 | — |
| Jefferson Neurology Associates-Site Number:8400016 | Philadelphia | Pennsylvania | 19107 | — |
| Premier Neurology-Site Number:8400069 | Greer | South Carolina | 29650 | — |
| Mountain View Clinical Research-Site Number:8400024 | Greer | South Carolina | 29651-1817 | — |
| Neurology Clinic, PC-Site Number:8400087 | Cordova | Tennessee | 38018 | — |
| Advanced Neuroscience Center-Site Number:8400035 | Franklin | Tennessee | 37064 | — |
| Baylor College of Medicine-Site Number:8400136 | Houston | Texas | 77030 | — |
| Neurology Center of San Antonio-Site Number:8400036 | San Antonio | Texas | 78258 | — |
| University Of Vermont College Of Medicine-Site Number:8400130 | Burlington | Vermont | 05401 | — |
| Medical College of Wisconsin-Site Number:8400028 | 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 255 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04411641, 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 Jul 2, 2025 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04411641 live on ClinicalTrials.gov.