Phase 3 Transverse Myelitis Trial, Completed NCT04201262 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 (NCT04201262) enrolled 105 adults in total — 58 received a medicine called ravulizumab and 47 received a placebo (an inactive dummy treatment). The trial was measuring whether ravulizumab could reduce relapses (sudden worsening episodes) in people with a rare nerve condition called NMOSD (neuromyelitis optica spectrum disorder). The main treatment period was followed by a longer-term extension phase, which only the ravulizumab group continued into. The reported data shows that, during the main treatment period, zero out of 58 participants in the ravulizumab group experienced a confirmed relapse, compared with 20 out of 47 participants in the placebo group. For the relapse rate measure (the average number of relapses per year across all participants), the ravulizumab group recorded 0.000 relapses per year and the placebo group recorded 0.350 relapses per year. On a walking ability scale (scored 0–9, where lower is better), 4 participants in each group showed worsening, while 52 in the ravulizumab group and 32 in the placebo group were reported as stable. On a broader disability scale, 6 ravulizumab participants and 11 placebo participants showed clinically meaningful worsening. For self-reported quality of life, small numerical differences between the two groups were recorded, though what those differences mean in everyday terms was not further explained in the submitted data. 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

NCT04201262
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 have been diagnosed with Neuromyelitis Optica Spectrum Disorder (NMOSD) and have tested positive for a specific antibody called anti-aquaporin-4 (confirm with trial site if unsure about your test results)
  • You have had at least 1 attack or relapse of your condition within the last 12 months before the study screening period
  • Your level of disability, as measured by a standard neurological scale, falls within a certain range — not too severely affected (confirm with trial site what score you have)
  • If you are already taking immune-suppressing medication, you have been on a steady, unchanged dose for a sufficient period of time before the screening stage
  • You weigh at least 40 kilograms (approximately 88 pounds)
  • You are willing and able to use an appropriate method of contraception as required by local guidelines for clinical trial participants

Who may not be able to join:

  • You have previously had a bacterial infection called Neisseria meningitidis (a type of meningitis)
  • You have HIV (Human Immunodeficiency Virus), confirmed by a blood test
  • You have previously been treated with, or are currently taking, a type of medication called a complement inhibitor
  • You have taken rituximab or mitoxantrone (specific immune system medications) within the 3 months before screening
  • You have received intravenous immunoglobulin (an immune system 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

Research Site, Camperdown,
Research Site, Fitzroy,

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
9 December 2019
Est. completion
15 March 2022

Where this trial is recruiting

🇦🇺 Australia 🇦🇹 Austria 🇨🇦 Canada 🇩🇰 Denmark 🇫🇷 France 🇩🇪 Germany 🇮🇹 Italy 🇯🇵 Japan 🇵🇱 Poland 🇰🇷 South Korea 🇪🇸 Spain 🇬🇧 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 an Adjudicated On-trial Relapse in the Primary Treatment Period

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