Phase 3 Multiple Sclerosis Trial, Terminated NCT01499667 Sponsor: Novartis Pharmaceuticals 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 enrolled 142 people with multiple sclerosis (50, 42, and 50 in each group respectively) who were switching from a medicine called natalizumab to another called fingolimod (also known as FTY720). The key question being studied was how many new or growing brain lesions — areas of damage visible on MRI brain scans — appeared during different "washout" periods (gaps between stopping one medicine and starting the other) of 8, 12, or 16 weeks. Around 112 participants completed the study across the three groups. The reported data shows that, for the main outcome — the number of active brain lesions from the last natalizumab dose through 8 weeks of fingolimod treatment — the 8-week washout group averaged 2.1 lesions, the 12-week washout group averaged 1.7 lesions, and the 16-week washout group averaged 8.2 lesions. The reported data also shows that during the washout period alone (before starting fingolimod), average lesion counts were 0.4, 2.1, and 3.6 for the 8-, 12-, and 16-week groups respectively. Over the full 24 weeks from the last natalizumab dose, the reported averages were 3.2, 4.4, and 7.7 lesions across the three groups. For disability scores (measured on a standard 0–10 scale where higher means greater disability), the reported changes from the starting point were small, ranging from −0.13 to +0.23 across groups and time points. For a measure of a different type of brain lesion (gadolinium-enhancing T1 lesions), some figures were reported but one data point for the 16-week group was listed as not available in the submitted results. 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, Terminated

NCT01499667
Terminated Phase 3 🇦🇺 Australian site

Who may 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 might be able to join this trial:

  • You have a type of multiple sclerosis called relapsing remitting MS.
  • You have been taking a medication called natalizumab for at least 6 months before the screening visit, and stopping this medication is being considered.

Who may not be able to join:

  • You have a long-term condition that affects your immune system.
  • You have Crohn's disease.
  • You have or have had certain types of cancer.
  • You have diabetes that is not well controlled.
  • You have certain eye conditions or disorders.
  • A blood test shows you have never been exposed to the chickenpox virus (varicella-zoster).
  • You have certain liver conditions.
  • Your white blood cell count is too low.
  • You are currently taking certain medications that suppress the immune system or certain heart medications.
  • Your resting heart rate is below 45 beats per minute.
  • You have certain heart or lung conditions.
  • You are unable to have MRI scans.

Please note: There may be additional criteria not listed here that could affect your eligibility (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 28 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Australian sites

Novartis Investigative Site, Box Hill, Victoria
Novartis Investigative Site, Heidelberg, Victoria

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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Trial details

Status
Terminated
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
1 September 2011
Est. completion
1 November 2012

Where this trial is recruiting

🇦🇺 Australia 🇦🇹 Austria 🇨🇿 Czechia 🇫🇮 Finland 🇩🇪 Germany 🇬🇷 Greece 🇭🇺 Hungary 🇮🇱 Israel 🇮🇹 Italy 🇪🇸 Spain 🇨🇭 Switzerland

2 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Number of Active (New or Newly Enlarging) T2 Lesions From the Last Natalizumab Infusion (Baseline) Through 8 Weeks of Fingolimod Treatment

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 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