Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial enrolled 618 people across three groups during the main (core) treatment period: 197 received a placebo (a dummy treatment with no active ingredient), 205 received a lower dose of teriflunomide (7 mg), and 216 received a higher dose (14 mg). The trial was measuring how long it took for participants — who had each experienced a single episode of neurological symptoms that could be an early warning sign of multiple sclerosis (MS) — to be diagnosed with clinically definite MS. A portion of participants who completed the core period then continued into an extension phase. The trial also looked at relapse rates and changes seen on brain MRI (brain scans). The reported data shows that, for the primary outcome — the estimated probability of being diagnosed with clinically definite MS by the end of the study (at 108 weeks) — the figures were 35.9% in the placebo group, 27.6% in the 7 mg group, and 24.0% in the 14 mg group. For a broader measure of MS diagnosis that also included MRI scan criteria, the reported probabilities at 108 weeks were 87.0% (placebo), 73.3% (7 mg), and 71.5% (14 mg). The reported average relapse rate per year was 0.284 for placebo, 0.190 for the 7 mg group, and 0.194 for the 14 mg group. Brain MRI scans also recorded the number of active lesions (areas of inflammation visible on the scan) per scan: 0.953 for placebo, 0.749 for the 7 mg group, and 0.395 for the 14 mg group. Changes in total lesion volume on the brain scans and the volume of active lesions were also reported, with the figures for all three groups described as small numerical differences; full details of those figures are available in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 25192851) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Multiple Sclerosis Trial, Completed
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who may be able to join
- You have had your first clear neurological episode (such as optic neuritis diagnosed by an eye doctor, problems with your spinal cord, or issues with balance/coordination) that doctors believe may be caused by damage to the protective coating of nerve fibers
- Your symptoms started within the last 90 days before joining the trial
- A recent MRI scan shows 2 or more spots (each at least 3mm in size) that are typical of multiple sclerosis (MS)
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- You have a serious ongoing condition affecting your heart, liver, nervous system, hormones, or another major part of your body
- You have significant problems with your bone marrow (the tissue inside bones that makes blood cells)
- You are currently pregnant or breastfeeding
- You have issues with alcohol or drug misuse
- You have previously taken certain medicines that suppress the immune system, including cladribine, mitoxantrone, azathioprine, cyclophosphamide, cyclosporin, methotrexate, or mycophenolate
- In the opinion of the trial doctor, there is any reason you may not be able to follow through with or complete the study (confirm with trial site)
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Trial contact details on record
Principal Investigator: Clinical Sciences & Operations, Sanofi
Australian sites
This trial is not accepting new participants. These are the contact details ClinicalTrials.gov holds for it, kept here for reference. They are not an invitation to enrol, and the sites listed may no longer be running this trial.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial was run
These are the locations recorded on the registry, including 4 in Australia. They are a historical record: this trial is not enrolling, so they are not places you can join it.
Primary endpoints
Core Treatment Period: Time to Conversion to Clinically Definite Multiple Sclerosis (CDMS)
Other options
Data last synced from ClinicalTrials.gov: 30 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.