A Study to Investigate Long-term Safety and Tolerability of Tolebrutinib in Participants With Multiple Sclerosis.
Public ClinicalTrials.gov record NCT06372145. 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
An Interventional, Phase 3 Extension Study to Investigate Long-term Safety and Tolerability of Tolebrutinib in Participants With Relapsing Multiple Sclerosis, Primary Progressive Multiple Sclerosis, or Nonrelapsing Secondary Progressive Multiple Sclerosis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a Phase 3 extension, global, multicenter study to assess the long-term safety and tolerability of tolebrutinib in adult participants (aged ≥18 years) with RMS, PPMS, or NRSPMS who were previously enrolled in the Phase 2b LTS (LTS16004) or 1 of the 4 Phase 3 tolebrutinib pivotal trials (GEMINI 1 \[EFC16033\], GEMINI 2 \[EFC16034\], HERCULES \[EFC16645\], or PERSEUS \[EFC16035\]). SUBSTUDY: ToleDYNAMIC substudy
Study identification
- NCT ID
- NCT06372145
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 2,500 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- 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
- Apr 16, 2024 (Actual)
- Primary completion
- Apr 30, 2029 (Estimated)
- Completion
- Apr 30, 2029 (Estimated)
- Last update posted
- Aug 17, 2026
2024 – 2029
United States locations
- U.S. sites
- 52
- U.S. states
- 27
- U.S. cities
- 50
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The University of Alabama at Birmingham- Site Number : 8400013 | Birmingham | Alabama | 35233 | — |
| ~North Central Neurology Associates, PC- Site Number : 8400009 | Cullman | Alabama | 35058 | — |
| Center for Neurology and Spine- Site Number : 8400089 | Phoenix | Arizona | 85018 | — |
| Collaborative Neuroscience Research- Site Number : 8400045 | Los Alamitos | California | 90720 | — |
| USC- Site Number : 8400143 | Los Angeles | California | 90033 | — |
| University of California San Diego Medical Center- Site Number : 8400101 | San Diego | California | 92037-0943 | — |
| Regina Berkovich, MD, PhD- Site Number : 8400059 | West Hollywood | California | 90048 | — |
| University of Colorado- Site Number : 8400012 | Denver | Colorado | 80262 | — |
| Advanced Neurosciences Research- Site Number : 8400025 | Fort Collins | Colorado | 80528 | — |
| Georgetown University Medical Center- Site Number : 8400119 | Washington D.C. | District of Columbia | 20007 | — |
| SFM Clinical Research, LLC- Site Number : 8400029 | Boca Raton | Florida | 33487 | — |
| University of Florida Health- Site Number : 8400159 | Gainesville | Florida | 32608 | — |
| Neurology Associates- Site Number : 8409902 | Maitland | Florida | 32751 | — |
| University of Miami- Site Number : 8400063 | Miami | Florida | 33136 | — |
| 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 : 8409905 | Tampa | Florida | 33612 | — |
| Velocity Clinical Research- Site Number : 8409903 | Savannah | Georgia | 31406 | — |
| Consultants In Neurology- Site Number : 8409906 | Northbrook | Illinois | 60062 | — |
| Springfield Clinic, LLP- Site Number : 8400071 | Springfield | Illinois | 62702 | — |
| Indiana University Health, Inc- Site Number : 8400039 | Fort Wayne | Indiana | 46815 | — |
| University of Kansas Medical Center- Site Number : 8400023 | Kansas City | Kansas | 66160-7321 | — |
| University of Kentucky- Site Number : 8400106 | Lexington | Kentucky | 40536 | — |
| Norton Neurology MS Services- Site Number : 8400127 | Louisville | Kentucky | 40207 | — |
| The NeuroMedical Center- Site Number : 8400057 | Baton Rouge | Louisiana | 70810 | — |
| Ochsner Clinic Foundation- Site Number : 8400107 | New Orleans | Louisiana | 70121 | — |
| 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 | — |
| Michigan Institute Neuro Disorders- Site Number : 8400058 | Farmington Hills | Michigan | 48334 | — |
| Memorial Healthcare Institute for Neuroscience- Site Number : 8400033 | Owosso | Michigan | 48867 | — |
| Minneapolis Clinic of Neurology- Site Number : 8400051 | Golden Valley | Minnesota | 55422 | — |
| Mayo Clinic- Site Number : 8400111 | Rochester | Minnesota | 55905 | — |
| Sharlin Health & Neurology- Site Number : 8400093 | Ozark | Missouri | 65721 | — |
| Missouri Baptist Medical Center- Site Number : 8400019 | St Louis | Missouri | 63131 | — |
| Lou Ruvo Center for Brain Health- Site Number : 8400117 | Las Vegas | Nevada | 89106 | — |
| University of New Mexico- Site Number : 8400032 | Albuquerque | New Mexico | 87131 | — |
| Mount Sinai Medical Center- Site Number : 8400038 | New York | New York | 10021 | — |
| NYU Langone South Shore Neurologic Associates- Site Number : 8400100 | Patchogue | New York | 11772 | — |
| Neurology Associates of Stony Brook- Site Number : 8400042 | Stony Brook | New York | 11794 | — |
| Wake Forest University Baptist Medical Center- Site Number : 8400116 | Winston-Salem | North Carolina | 27157 | — |
| Dayton Center for Neurological Disorders- Site Number : 8400081 | Centerville | Ohio | 45459 | — |
| Cleveland Clinic Foundation-Mellen Center for MS- Site Number : 8400125 | Cleveland | Ohio | 44195 | — |
| The Ohio State University Wexner Medical Center- Site Number : 8400150 | Columbus | Ohio | 43221 | — |
| The Boster Center for Multiple Sclerosis- Site Number : 8400147 | Columbus | Ohio | 43235 | — |
| UC Health, LLC- Site Number : 8409901 | Dayton | Ohio | 45417 | — |
| Providence Multiple Sclerosis Center- Site Number : 8400020 | Portland | Oregon | 97225 | — |
| Premier Neurology- Site Number : 8400069 | Greenville | South Carolina | 29605 | — |
| HOPE Neurology- Site Number : 8409904 | Knoxville | Tennessee | 37922 | — |
| Lone Star Neurology of San Antonio- Site Number : 8400036 | San Antonio | Texas | 78258 | — |
| University of Vermont - Larner College of Medicine- Site Number : 8400130 | Burlington | Vermont | 05405 | — |
| Neurological Associates- Site Number : 8400097 | Richmond | Virginia | 23229 | — |
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 300 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06372145, 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 Aug 17, 2026 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06372145 live on ClinicalTrials.gov.