Phase 3 Transverse Myelitis Trial, Terminated NCT01892345 Sponsor: Alexion Pharmaceuticals, Inc. Condition: Transverse Myelitis
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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 (NCT01892345) enrolled 143 people in total — 96 in the eculizumab group and 47 in the placebo group. The trial was measuring outcomes in people with a neurological condition, with the main question being how many participants experienced a confirmed relapse (a new or worsening bout of neurological symptoms lasting more than 24 hours, verified by a doctor and reviewed by an independent committee) during the study period. Secondary measurements included how often relapses occurred over time, changes in disability scores, walking ability, and participants' own ratings of their health. The reported data shows that, for the primary outcome, 3 out of 96 participants in the eculizumab group had a confirmed on-trial relapse, compared with 20 out of 47 participants in the placebo group. For the secondary outcome of annualised relapse rate — that is, the average number of relapses per year of time spent in the study — the reported figures were 0.016 for the eculizumab group and 0.350 for the placebo group. The reported data also shows changes in several disability and function scales from the start to the end of the study. On a disability scale from 0–10, the eculizumab group's average score changed by −0.18 (a small decrease) and the placebo group's by +0.12 (a small increase). On a disability/dependence scale from 0–6, the changes were −0.2 and +0.1 respectively. On a walking ability scale from 0–9, the changes were −0.4 and +0.5 respectively. On a self-rated health scale from 0–100, participants in the eculizumab group reported an average change of +5.4 points and those in the placebo group +0.6 points. In all cases, a move in the negative direction on the disability/walking scales and a move in the positive direction on the health rating scale indicates improvement as defined by the trial. 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 Transverse Myelitis Trial, Terminated

NCT01892345
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 are 18 years of age or older, either male or female
  • You have been diagnosed with NMO (Neuromyelitis Optica) or a related condition called NMOSD
  • You have tested positive for a specific antibody called AQP4 (confirm with trial site)
  • You have had at least 2 relapses (flare-ups of your condition) in the past 12 months, OR at least 3 relapses in the past 24 months with at least 1 of those happening in the last 12 months
  • Your level of disability, as measured by a standard medical scale, falls within a certain range (confirm with trial site)
  • If you are already taking medication to prevent relapses, your dose must have been stable and unchanged for a set period before joining, and you must be able to keep it the same throughout the study
  • If you are a woman who could become pregnant, you must have a negative pregnancy test before joining and must use reliable contraception during the study and for up to 5 months after finishing treatment

Who may not be able to join:

  • You have taken a medication called rituximab within the 3 months before screening
  • You have taken a medication called mitoxantrone within the 3 months before screening
  • You have received intravenous immunoglobulin (a treatment given through a drip) within the 3 weeks before screening

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

Australian sites

University of Sydney, Brain and Mind Center, Camperdown, New South Wales
St. Vincent's Hospital Melbourne, Fitzroy, Victoria

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

Status
Terminated
Phase
Phase 3
Sponsor
Alexion Pharmaceuticals, Inc.
Registry
ClinicalTrials.gov
Start date
11 April 2014
Est. completion
17 July 2018

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇭🇷 Croatia 🇨🇿 Czechia 🇩🇰 Denmark 🇩🇪 Germany Hong Kong 🇮🇹 Italy 🇯🇵 Japan 🇲🇾 Malaysia 🇷🇺 Russia 🇰🇷 South Korea 🇪🇸 Spain 🇹🇼 Taiwan 🇹🇭 Thailand Turkey (Türkiye) 🇬🇧 United Kingdom 🇺🇸 United States

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

Primary endpoints

Participants With An Adjudicated On-trial Relapse

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