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Could a drug speed recovery from Guillain-Barré syndrome?

NCT ID NCT04752566

Disease control Sponsor: Alexion Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This Phase 3 trial tested the drug eculizumab in 57 people with severe Guillain-Barré syndrome (GBS), a rare nerve disorder that can cause paralysis. Participants received either eculizumab or a placebo once a week for four weeks, alongside standard treatment. The study measured how quickly they regained the ability to walk and run. Results from this completed Japanese study may show whether eculizumab helps speed recovery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
eculizumab (Soliris)
What this could lead to
If successful, eculizumab could offer a new treatment option to help people with severe Guillain-Barré syndrome recover faster and regain mobility.
What could go wrong
This is a small, completed Phase 3 trial in Japan only, so results may not apply broadly. Eculizumab carries risks like increased susceptibility to infections.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

57 people

The number who actually took part.

Started

Mar 2021

Finished

Aug 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participants who meet the GBS criteria. * Participants who were able to run prior to onset of GBS symptoms. * Participants with onset of weakness due to GBS \< 2 weeks before screening. * Participants unable to walk unaided for ≥ 5 meters (progressively deteriorating FG3 or FG4 to FG5). * Participants who are already on IVIg or deemed eligible for and who will start IVIg. * Participants who can start their first dose of study drug before the end of the IVIg treatment period. Exclusion Criteria: * Participants who have previously received or are currently receiving treatment with complement modulators. * Participants who have been administered another investigational product within 30 days or 5 half-lives (whichever is longer) prior to providing consent or are currently participating in another interventional study. * Participants who have received rituximab within 12 weeks prior to screening. * Participants who are being considered for or are already on plasmapheresis. * Participants who have received immunosuppressive treatment during the 4 weeks prior to providing consent.

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Conditions

The condition(s) this trial relates to.

Guillain-Barre syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Guillain-Barre syndrome

Contacts and locations

Locations

  • Research Site

    Bunkyō City, 113-8519, Japan

  • Research Site

    Chiba, 260-0877, Japan

  • Research Site

    Fukuoka, 814-0180, Japan

  • Research Site

    Hiroshima, 730-8518, Japan

  • Research Site

    Kagoshima, 890-8520, Japan

  • Research Site

    Kawagoe-shi, 350-8550, Japan

  • Research Site

    Kawasaki-shi, 216-8511, Japan

  • Research Site

    Kitakyushu-shi, 807-8555, Japan

  • Research Site

    Kobe, 650-0047, Japan

  • Research Site

    Kumamoto, 860-8556, Japan

  • Research Site

    Kurashiki-shi, 710-8602, Japan

  • Research Site

    Matsumoto-shi, 390-8621, Japan

  • Research Site

    Mitaka-shi, 181-8611, Japan

  • Research Site

    Nagoya, 466-8560, Japan

  • Research Site

    Niigata, 951-8520, Japan

  • Research Site

    Nishinomiya-shi, 663-8501, Japan

  • Research Site

    Sapporo, 060-8648, Japan

  • Research Site

    Sayama, 589-8511, Japan

  • Research Site

    Sendai, 983-8520, Japan

  • Research Site

    Shimotsuga-gun, 321-0293, Japan

  • Research Site

    Ube-shi, 755-8505, Japan

  • Research Site

    Yokohama, 236-0004, Japan

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