CompletedPhase 3

Safety and Efficacy of Eculizumab in Refractory Generalized Myasthenia Gravis (REGAIN Study)

United States125 participantsStarted 2013-12

Plain-language summary

The purpose of this study is to determine if eculizumab is safe and effective for the treatment of refractory generalized Myasthenia Gravis.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Positive serologic test for anti-AChR Abs as confirmed at screening, and
✓. One of the following:
✓. History of abnormal neuromuscular transmission test demonstrated by single-fiber electromyography (SFEMG) or repetitive nerve stimulation, or
✓. History of positive anticholinesterase test, e.g. edrophonium chloride test, or
✓. Subject has demonstrated improvement in MG signs on oral cholinesterase inhibitors, as assessed by the treating physician.
✓. Failed treatment with at least two immunosuppressive agents. Or,
✓. Failed treatment with at least one immunosuppressive agent and require chronic plasma exchange or IVIg

What they're measuring

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)

Timeframe: End of study (Week 26)

Trial details

NCT IDNCT01997229

SponsorAlexion Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-02

Results submitted2017-11-21

View on ClinicalTrials.gov More Refractory Generalized Myasthenia Gravis trials