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Tolebrutinib for Multiple Sclerosis (HERCULES Trial)
HERCULES Trial Summary
This trial is testing a new drug to see if it can help people with NRSPMS by delaying disability progression.
HERCULES Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowHERCULES Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.HERCULES Trial Design
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Who is running the clinical trial?
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- I have taken medication for MS recently.I am not taking strong drugs that affect liver enzymes CYP3A or CYP2C8.I have not been hospitalized for a psychiatric condition in the last 2 years.I have had cancer within the last 5 years.I have not received a live vaccine in the last 2 months.I do not have an ongoing infection that could interfere with the study.I have a history of bleeding disorders or platelet problems.I have had an organ transplant.I do not have HIV, hepatitis B or C, TB, PML, or other serious infections.I am between 18 and 60 years old.I am on blood thinners like aspirin (over 81mg/day), clopidogrel, or warfarin.I have not had major surgery in the last 4 weeks and do not plan any during the study.I am not pregnant or breastfeeding, and if I can have children, I agree to use birth control.I have been diagnosed with secondary progressive MS not experiencing relapses.I haven't had any symptoms or relapses for at least 2 years.
- Group 1: Placebo
- Group 2: SAR442168
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are people of legal age being accepted into this research project?
"This study requires that participants are between the ages of 18-60, as stated in the inclusion criteria."
Is this trial being conducted at multiple sites?
"So far, this study has recruited 85 patients from across the country, with additional locations still enrolling individuals. For example, 8400070 in Arcadia, 8400136 in Houston, and 8400083 in Cleveland are all still looking for participants."
What is the Tolebrutinib FDA regulatory status?
"Tolebrutinib's safety was rated a 3 by our analysts at Power. This is due to the fact that Tolebrutinib is in Phase 3 trials, meaning that there is data to support both its efficacy and safety."
What is the total number of test subjects in this clinical trial?
"Indeed, the information available on clinicaltrials.gov does show that this study is presently enrolling patients. The study was originally posted on September 24th, 2020 and was last edited on September 30th, 2020. A total of 1290 participants are needed, and 85 sites have been selected."
Are there any restrictions for who can opt-in to this experiment?
"This study is looking for 1290 participants that fit the following criteria: between 18-60 years old, have multiple sclerosis, have an EDSS score between 3.0-6.5, have documented evidence of disability progression in the 12 months before screening, are not a WOCBP OR are a WOCBP and agree to use an acceptable contraceptive method, contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies, absence of clinical relapses for at least 24 months."
Who else is applying?
What state do they live in?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
What site did they apply to?
Why did patients apply to this trial?
What questions have other patients asked about this trial?
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