Phase 3 Myasthenia Gravis Trial, Completed NCT01997229 Sponsor: Alexion Pharmaceuticals, Inc. Condition: Myasthenia Gravis
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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 (NCT01997229) enrolled 125 people with myasthenia gravis — a condition that affects muscle strength and control. Sixty-two participants were assigned to receive eculizumab and 63 received a placebo (an inactive treatment used for comparison). The main thing the trial was measuring was any change in day-to-day functioning over 26 weeks, using a tool called the Myasthenia Gravis Activities of Daily Living (MG-ADL) scale, which captures how the condition affects routine tasks like eating, speaking, and breathing. The reported data shows that results were analysed using a "worst-rank" method. In this approach, all 125 participants were given a rank between 1 and 125 — where a rank of 1 represented the best reported outcome and a rank of 125 represented the worst. The eculizumab group received an average rank of 56.6, while the placebo group received an average rank of 68.3. A lower average rank in this system indicates a relatively better position within the group as a whole. No other outcome measures were included in the structured results data submitted to ClinicalTrials.gov, so no further figures can be reported here. 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 Myasthenia Gravis Trial, Completed

NCT01997229
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 are 18 years old or older (male or female)
  • You have been diagnosed with Myasthenia Gravis (MG), confirmed by a blood test showing specific antibodies (anti-AChR), plus at least one other test or sign of the condition, such as a nerve/muscle function test, a medication response test, or improvement with MG medication
  • Your MG symptoms are rated as moderate to severe (Class II to IV) based on a standard MG classification system, as assessed at your screening visit
  • Your MG symptoms are significantly affecting your daily life, with a symptom score of 6 or higher on a standard scale (MG-ADL) at both your screening and start-of-treatment visits
  • You have tried at least two medications that suppress the immune system and they did not work well enough, OR you have tried at least one such medication without success and you currently need regular plasma exchange or intravenous immunoglobulin (IVIg) treatments to manage your condition

Who may not be able to join:

  • You have a history of a thymoma (a tumor of the thymus gland) or any other thymus-related tumor
  • You have had your thymus gland removed within the last 12 months before screening
  • Your MG symptoms are very mild (Class I) or you are currently in a severe MG crisis (Class V) at the time of screening
  • You have received a medication called rituximab within the last 6 months before screening
  • You have received IVIg or plasma exchange treatment within the 4 weeks before your start-of-treatment visit

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

St Vincent's Hospital Melbourne, Fitzroy, Victoria
Royal Perth Hospital, Perth, Western Australia

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
1 December 2013
Est. completion
1 February 2016

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇧🇪 Belgium 🇧🇷 Brazil 🇨🇦 Canada 🇨🇿 Czechia 🇩🇰 Denmark 🇫🇮 Finland 🇫🇷 France 🇩🇪 Germany 🇬🇷 Greece 🇭🇺 Hungary 🇮🇹 Italy 🇯🇵 Japan 🇳🇱 Netherlands 🇰🇷 South Korea 🇪🇸 Spain 🇸🇪 Sweden Turkey (Türkiye) 🇬🇧 United Kingdom 🇺🇸 United States

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

Primary endpoints

Myasthenia Gravis Activities of Daily Living Profile (MG-ADL): Change From Baseline in MG-ADL Total Score at Week 26 by Worst-Rank Analysis of Covariance (ANCOVA)

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