Phase 3 Multiple Sclerosis Trial, Completed NCT00355134 Sponsor: Novartis Condition: Multiple Sclerosis
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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 involved people with multiple sclerosis (MS) and ran in two phases. In the main (core) phase, 370 people received fingolimod at a higher dose (1.25 mg), 358 received it at a lower dose (0.5 mg), and 355 received a placebo (a dummy treatment with no active ingredient) — for a total of 1,083 participants. Some of these participants then continued into an extension phase, where those previously on placebo were switched to one of the two fingolimod doses. The trial was primarily measuring the average number of MS relapses (episodes of new or worsening symptoms) per year in each group over 24 months. The reported data shows that over the core 24-month phase, the estimated average number of relapses per year was 0.203 for the higher-dose group, 0.208 for the lower-dose group, and 0.403 for the placebo group. When relapse rates were calculated across the full study period (including the extension phase), the reported figures were 0.180, 0.192, and 0.363 respectively. The reported data also shows MRI brain scan measurements. Brain volume declined in all three groups over two years, with the placebo group showing a reported change of −1.279% compared to −0.595% (higher dose) and −0.858% (lower dose). The average number of new or newly enlarged areas of inflammation visible on MRI scans was reported as 1.6 (higher dose), 2.3 (lower dose), and 8.9 (placebo) over the first year. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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

NCT00355134
Completed Phase 3 🇦🇺 Australian site

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 are a man or woman between the ages of 18 and 55 who has been diagnosed with multiple sclerosis
  • Your multiple sclerosis follows a relapsing-remitting pattern, meaning you have flare-ups followed by periods of recovery
  • Your level of disability, as measured by a standard MS scoring scale, falls within a certain range (a score of 0 to 5.5 — confirm with trial site if you are unsure of your score)

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 another long-term condition affecting the immune system, cancer, a serious lung condition, heart failure, or similar serious health conditions
  • You are currently pregnant or breastfeeding
  • For a later stage (extension phase) of the trial: you must have completed the first 24 months of the study, and you would not be eligible if you had to stop taking the study drug during that time due to side effects, serious health events, or abnormal test results
  • There may be additional requirements not listed here that the trial site will check (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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 30 July 2026

Trial contact details on record

Principal Investigator: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Australian sites

Novartis Investigative Site, North Gosford, New South Wales

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

Status
Completed
Phase
Phase 3
Sponsor
Registry
ClinicalTrials.gov
Start date
1 June 2006
Est. completion
1 June 2011

Where this trial was run

🇦🇺 Australia 🇦🇹 Austria 🇨🇦 Canada 🇵🇱 Poland 🇷🇴 Romania Turkey (Türkiye) 🇬🇧 United Kingdom 🇺🇸 United States

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

Aggregate Annualized Relapse Rate (ARR) Estimate up to Month 24

Other options

Expanded access pathways

This trial is not enrolling. Other access pathways exist in general: in Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients. Whether it applies to any treatment studied here is a question for your doctor — nothing on this page says it does.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

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.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov