Phase 3 Myasthenia Gravis Trial, Completed NCT00294658 Sponsor: University of Alabama at Birmingham 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 enrolled 126 people with myasthenia gravis (a condition that causes muscle weakness). Participants were randomly placed into one of two groups: 66 people received surgery to remove the thymus gland (thymectomy) plus the steroid medication prednisone, while 60 people received prednisone alone. The trial followed participants for up to three years and measured two main things: their muscle weakness scores using a standard scale called the Quantitative Myasthenia Gravis (QMG) test (where a score of 0 means no weakness and 39 means the most severe weakness), and the average dose of prednisone they were taking over that time. By the end of the study, 60 people in the surgery-plus-prednisone group and 51 in the prednisone-alone group had completed the trial. The reported data shows that, averaged across the three-year follow-up period, the surgery-plus-prednisone group had a mean QMG weakness score of 6.15, compared with 8.99 in the prednisone-alone group. For the average prednisone dose taken on alternating days, the reported data shows the surgery-plus-prednisone group averaged 32 mg, while the prednisone-alone group averaged 54 mg. Secondary analyses broke these same measurements down by subgroups — such as whether participants were already on prednisone at the start, their sex, and their age when the condition first appeared — and the reported numbers followed a similar pattern across all subgroups, though the specific figures varied slightly between subgroups. 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

NCT00294658
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 male or female, aged between 18 and 65 years, and have been diagnosed with Myasthenia Gravis (MG), a condition that causes muscle weakness
  • Your MG has spread beyond just your eyes to affect other parts of your body, and this started within the last 5 years
  • A blood test has shown a specific antibody related to MG at a certain level, or you have had another confirmed test (such as a nerve or muscle test) that supports the diagnosis
  • Your MG causes a moderate to significant level of weakness (not the mildest or most severe level), and you are already being treated with the best available anti-MG medications, with or without a steroid called prednisone

Who may not be able to join:

  • Your MG only affects your eyes and does not cause weakness in the rest of your body, or your weakness is too mild to need steroid treatment
  • You needed a breathing tube due to severe MG weakness in the past month
  • You have taken immune-suppressing medications (other than steroids) in the past year
  • Your doctors have determined that surgery on your thymus gland (a small gland in your chest) would not be safe for you
  • A chest scan has shown a growth or tumour on your thymus gland
  • You are currently pregnant, breastfeeding, planning to become pregnant during the study, or have a medical reason why you cannot take steroids (unless you are past menopause or have had surgery that means you cannot become pregnant)
  • You have another serious medical, neurological, or mental health condition that could interfere with the surgery or follow-up assessments
  • You are currently taking a high daily dose of prednisone above the levels specified for this trial (confirm with trial site)
  • You are currently taking part in another clinical trial
  • You have had problems with alcohol or drug misuse within the past 2 years

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

Principal Investigator: Gary Cutter, PhD, University of Alabama at Birmingham School of Public Health, Department of Biostatistics

Australian sites

University of Sydney, Royal Prince Alfred Hospital and The University of Sydney, Sydney,
University of Melbourne, Melbourne, The Royal Melbourne Hospital, Dept of Neurology, Royal Melbourne Hospital, Victoria,

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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Trial details

Status
Completed
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
1 June 2006
Est. completion
1 November 2015

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇧🇷 Brazil 🇨🇦 Canada 🇨🇱 Chile 🇩🇪 Germany 🇮🇹 Italy 🇯🇵 Japan 🇲🇽 Mexico 🇳🇱 Netherlands 🇵🇱 Poland 🇵🇹 Portugal 🇿🇦 South Africa 🇪🇸 Spain 🇹🇼 Taiwan 🇹🇭 Thailand 🇬🇧 United Kingdom 🇺🇸 United States

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

Primary endpoints

Time-weighted Average Quantitative Myasthenia Gravis Weakness Score Over 3 Years; Time-weighted Average Alternate-day Prednisone Dose (mg) Measured Over 3 Years

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