Trials / Completed
CompletedNCT01997229
Safety and Efficacy of Eculizumab in Refractory Generalized Myasthenia Gravis (REGAIN Study)
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)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 125 (actual)
- Sponsor
- Alexion Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine if eculizumab is safe and effective for the treatment of refractory generalized Myasthenia Gravis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Eculizumab | Induction Phase: 900 mg IV weekly X 4 Maintenance Phase: 1200 mg IV every 2 weeks during Weeks 4-26 |
| DRUG | Placebo | Placebo |
Timeline
- Start date
- 2013-12-01
- Primary completion
- 2016-02-01
- Completion
- 2016-06-01
- First posted
- 2013-11-28
- Last updated
- 2019-07-16
- Results posted
- 2018-02-07
Locations
114 sites across 21 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Japan, Netherlands, South Korea, Spain, Sweden, Turkey (Türkiye), United Kingdom
Source: ClinicalTrials.gov record NCT01997229. Inclusion in this directory is not an endorsement.