Clinical trial

Safety and Efficacy of Eculizumab in Refractory Generalized Myasthenia Gravis…

NCT01997229 · Alexion Pharmaceuticals, Inc., Industry · Completed

Key facts

NCT number NCT01997229
Title Safety and Efficacy of Eculizumab in Refractory Generalized Myasthenia Gravis (REGAIN Study)
Official title A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Eculizumab in Subjects With Refractory Generalized Myasthenia Gravis (gMG)
Lead sponsor Alexion Pharmaceuticals, Inc., Industry
Status Completed
Phase Phase 3
Study type Interventional
Conditions Refractory Generalized Myasthenia Gravis
Intervention type Biological, Drug
Interventions Eculizumab, Placebo
Enrollment 125
Start date Dec 1, 2013
Primary completion Feb 1, 2016
Completion Jun 1, 2016
First posted Nov 28, 2013
Last update posted Jul 16, 2019
Countries Argentina, Australia, Belgium, Brazil, Canada, Czechia, Denmark, Finland, France, Germany, Greece, Hungary and 9 more

At a glance

  • 100–999 Study sites
  • Yes Results posted
  • None Linked FDA submissions

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date:

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