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 517 people in total across its main double-blind phase, with 171 assigned to receive a drug called RNF (rebif novel formulation) three times a week, 175 assigned to receive RNF once a week, and 171 assigned to receive a placebo (an inactive treatment). All participants had experienced their first episode of symptoms that could suggest the beginnings of multiple sclerosis (MS). The trial was primarily measuring how long it took for participants to be formally diagnosed with MS according to a standard set of diagnostic criteria. The study ran in several phases, including a blinded phase of up to 24 months and later open-label and extension phases where some participants continued on active treatment for up to 36 months. The reported data shows that, for the primary outcome during the double-blind phase, the median time (that is, the midpoint — half of participants crossed this threshold earlier, half later) until a diagnosis of MS was reached was 310 days in the three-times-weekly RNF group, 182 days in the once-weekly RNF group, and 97 days in the placebo group. For the secondary outcome measuring time to a "clinically definite" MS diagnosis — based on a second attack or a sustained worsening on a disability scale — the reported data shows "NA" (not available) for all three groups in both the 24-month and 36-month phases, meaning those specific figures were not reported. For MRI-based measures in the extension phase, the reported data shows the average number of new or active brain lesions per person per scan ranged from 0.00 to 1.56 depending on the group and lesion type, and changes in lesion volume from the start of the study to month 36 also varied across groups, with figures not reported as directly comparable without further context. 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 38560407) ↗
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 had your first episode of possible MS symptoms within the last 60 days, lasting at least 24 hours, involving neurological changes (not just tingling sensations, bladder/bowel issues, or thinking problems)
- A brain MRI scan shows at least two inactive (symptom-free) lesions that are 3mm or larger, with at least one being oval-shaped, near the centre of the brain, or in the lower part of the brain
- Your disability score (a standard MS scale) falls between 0 and 5.0 at some point during the screening period
- You are between 18 and 50 years old (inclusive)
- You are willing and able to follow all study procedures
- You have signed a written consent form agreeing to take part
- If you are female, you must not be pregnant, breastfeeding, or trying to conceive, and must be using a highly reliable form of contraception (such as implants, injections, combined contraceptive pill, certain coils, abstinence, or a vasectomised partner)
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 already been formally diagnosed with MS (using 2005 McDonald criteria)
- Another condition could better explain your symptoms
- You have had complete paralysis across the spinal cord or vision loss in both eyes at the same time
- You have previously used or are currently using any approved MS medication
- You have taken part in another research study or used an experimental treatment within the last 12 weeks
- You have used steroid tablets or injections (including ACTH) within the last 30 days
- Your liver function blood tests are significantly above the normal range (confirm with trial site)
- Your blood counts are too low, including white blood cells, platelets, or haemoglobin (confirm with trial site)
- You currently have an autoimmune condition
- You have a serious physical or mental health condition, including a current or past history of severe depression or thoughts of suicide
- You have a history of seizures that are not well controlled by treatment
- You have a heart condition such as angina, heart failure, or irregular heartbeat
- You have a known allergy to interferon-beta or any ingredients in the study medication
- You have any condition that would prevent you from having an MRI scan
- You have a known allergy to the contrast dye used in MRI scans (gadolinium-DTPA)
- You have previously taken part in this same trial
- You have taken part in any clinical trial within the past 6 months
- You have ever used any immune-modifying or immune-suppressing treatments, including a wide range of specific medications such as interferon, glatiramer acetate, natalizumab, or others (confirm full list with trial site)
- You have used any experimental MS treatments before joining, including statins taken specifically to prevent MS
- You have a history of alcohol or drug misuse
- You are unable to tolerate both paracetamol (acetaminophen) and ibuprofen
- You are unable to give yourself (or have a carer give you) injections under the skin
- You have moderate to severe kidney problems
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.
If you need support right now
This page includes language about suicide and self-harm, because that is how the trial's eligibility criteria are written. If reading it has been hard, you do not have to keep going. The services below are free, confidential, and answered by people trained for exactly this.
If you or someone else is in immediate danger, call 000.
- Lifeline — 24/7 crisis support: 13 11 14
- Suicide Call Back Service — 24/7 counselling: 1300 659 467
- 13YARN — 24/7, for Aboriginal and Torres Strait Islander people: 13 92 76
- Beyond Blue — 24/7 mental health support: 1300 22 4636
- Emergency: 000
Outside Australia? The numbers above are Australian and will not work from overseas. Find a Helpline is a free directory of crisis lines in over 130 countries, run by ThroughLine with the International Association for Suicide Prevention. If you are in immediate danger, call your local emergency number.
Voxsanity is not a crisis service, and nothing on this page is medical advice. More Australian services are listed on our support lines page.
Trial contact details on record
Principal Investigator: Bettina M. Stubinski, MD, Merck Serono S.A., Geneva
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 1 in Australia. They are a historical record: this trial is not enrolling, so they are not places you can join it.
Primary endpoints
Time to Conversion to Multiple Sclerosis (MS) According to the McDonald Criteria (2005); Time to Conversion to Multiple Sclerosis (MS) According to the McDonald Criteria (2005)
Other options
Data last synced from ClinicalTrials.gov: 10 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.