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 1,094 people with multiple sclerosis (MS) who all received the medication natalizumab — there was no comparison group. The trial was measuring changes in disability over time using a standard MS disability scale called the EDSS, which runs from 0 (no disability) to 10 (death due to MS). The trial tracked how long it took for participants' disability scores to either worsen or improve in a meaningful and lasting way. Of the 1,094 people who started, 489 completed the study and 605 did not complete it; the reasons for not completing were not detailed in the data provided. The reported data shows that, on average, it took approximately 121.9 weeks (roughly 2 years and 4 months) before a worsening in disability score was confirmed and sustained for at least 24 weeks, and approximately 130.1 weeks (roughly 2 years and 6 months) before a worsening was confirmed and sustained for at least 48 weeks. These figures represent the median time — that is, the point at which half of participants had reached that level of change. The reported data also shows that, among participants who started with a disability score of 2.0 or above, the average time to a confirmed and sustained improvement in their disability score (lasting at least 24 weeks) was approximately 48.1 weeks (roughly 11 months). It is worth noting that because this trial had only one group — everyone received natalizumab — these numbers cannot be directly compared to an untreated group within this study. The data describes what was observed and measured, not whether the medication caused those observations. 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 20737510) ↗
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
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 multiple sclerosis (MS) and previously completed one of three specific earlier studies (NCT00027300, NCT00030966, or NCT00097760), including a required safety check-up such as a neurological exam or brain scan, OR you took part in a study called STARS (IMA 04001)
- Your doctor believes you do not have any signs or symptoms of a serious brain infection called progressive multifocal leukoencephalopathy (PML) (confirm with trial site)
- You are willing to stop taking and stay off other MS treatments that affect the immune system — including interferon-beta or glatiramer acetate — while receiving the study drug (natalizumab)
- If you are in Canada and completed 48 weeks of treatment in a related study (NCT00306592), you may also be allowed to join at a certain point in this trial
Who may not be able to join:
- Your doctor believes your immune system is weakened or not working properly
- You have previously tested positive for antibodies against the study drug (natalizumab) on more than one occasion in a prior study
- You have a history of a serious illness or cancer
- You had to stop taking natalizumab in a previous study because of an allergic reaction
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.
Contact this trial
Principal Investigator: Medical Director, Biogen
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
3 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Time to 24-week Confirmed Expanded Disability Status Scale (EDSS) Progression; Time to 48-week Confirmed EDSS Progression; Time to 24-week Confirmed EDSS Improvement Where Baseline ≥ 2.0
Can't join this trial?
Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.