At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 117 enrolled
Drug / intervention
Eculizumab +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Open-label Extension Trial of ECU-MG-301 to Evaluate the Safety and Efficacy of Eculizumab in Subjects With Refractory Generalized Myasthenia Gravis (gMG)
In Brief
A Phase 3 clinical trial evaluating Eculizumab and Placebo for Refractory Generalized Myasthenia Gravis. Completed, enrolled 117 participants across 60 sites in 17 countries.
Detailed Summary
To evaluate the safety and efficacy of eculizumab in the treatment of refractory generalized myasthenia gravis (gMG) as an extension study for the participants who previously completed Study ECU-MG-301(NCT01997229).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRefractory Generalized Myasthenia Gravis
CountriesArgentina, Belgium, Brazil, Canada, Czechia, Denmark, Finland, Hungary, Italy, Japan, Netherlands, South Korea, Spain, Sweden, Turkey (Türkiye), United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartNov 2014
First PostedNov 2014
Primary CompletionJan 2019
TodayJul 2026
First PostedNov 26, 2014
Enrollment StartNov 12, 2014
Primary CompletionJan 15, 2019
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 11.6 years ago
Interventions
Eculizumabbiological
Intravenous administration of eculizumab.
Placebodrug
Intravenous administration of matching placebo. Participants received placebo only during the Blind Induction Phase.