Phase 3 Transverse Myelitis Trial, Completed NCT02003144 Sponsor: Alexion Pharmaceuticals, Inc. Condition: Transverse Myelitis
Back to Transverse Myelitis

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 (NCT02003144) enrolled 119 participants in total — 41 in the "Placebo then Eculizumab" group and 78 in the "Eculizumab throughout" group. The trial was measuring a range of things, including how many participants experienced unwanted medical events (called adverse events), any thoughts or behaviours related to suicide (using a standardised questionnaire), and how often participants had relapses — that is, new or worsening neurological symptoms lasting more than 24 hours. The trial had two phases: a blinded phase (where some participants received a dummy treatment) and an open-label phase (where everyone received the active treatment). All 119 participants completed the first phase, while 32 and 64 respectively completed the second phase. The reported data shows that during the study, all 41 participants in the Placebo/Eculizumab group and 70 out of 78 in the Eculizumab/Eculizumab group experienced at least one adverse event (an unwanted medical occurrence of any kind). Serious adverse events were reported in 14 participants in the Placebo/Eculizumab group and 26 in the Eculizumab/Eculizumab group. Regarding relapses, 5 participants in the Placebo/Eculizumab group and 8 in the Eculizumab/Eculizumab group had at least one relapse during the trial. The reported relapse rate (calculated as relapses per year of time spent in the study) was 0.128 for the Placebo/Eculizumab group and 0.061 for the Eculizumab/Eculizumab group. On the suicide-related thoughts and behaviours questionnaire, 4 participants in the Placebo/Eculizumab group and 5 in the Eculizumab/Eculizumab group recorded at least one relevant response. The reported data also shows changes in two disability scales over the course of the study. On the EDSS scale (which runs from 0, meaning no disability, to 10, meaning death, with lower scores being better), both groups showed small decreases from their starting scores across various time points, with changes generally ranging from around −0.11 to −0.39. On the Modified Rankin Scale (which runs from 0, meaning no symptoms, to 6, meaning death), both groups also showed small decreases from starting scores, with changes ranging from roughly −0.04 to −0.62 across different time points. It is worth noting that both groups started with somewhat different baseline scores on these scales, which the reported data does not account for in these raw figures. 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, Completed

NCT02003144
Completed 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 must have already completed a previous clinical trial called ECU-NMO-301.
  • You must be willing and able to give your written agreement (consent) to take part.

Who may not be able to join:

  • You cannot join if you left the ECU-NMO-301 trial early because of a side effect or bad reaction to the trial medication.
  • Women who are pregnant, breastfeeding, or planning to become pregnant during the trial are not eligible to join.

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

Brain and Mind Research Institute, Camperdown, New South Wales
St. Vincent's Hospital, 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
Completed
Phase
Phase 3
Sponsor
Alexion Pharmaceuticals, Inc.
Registry
ClinicalTrials.gov
Start date
12 January 2015
Est. completion
12 July 2021

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇨🇦 Canada 🇨🇴 Colombia 🇭🇷 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

Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events; Number of Participants With At Least 1 Post Baseline Columbia-Suicide Severity Rating Scale (C-SSRS) Assessment (Suicide-Related Thoughts or Behaviours) Abnormality; Number of Participants With An On-trial Relapse as Determined by The Treating Physician; On-Trial Annualized Relapse Rate (ARR) as Determined by The Treating Physician

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