Trials / Terminated
TerminatedNCT01892345
A Randomized Controlled Trial of Eculizumab in AQP4 Antibody-positive Participants With NMO (PREVENT Study)
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Trial to Evaluate the Safety and Efficacy of Eculizumab in Patients With Relapsing Neuromyelitis Optica (NMO)
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 143 (actual)
- Sponsor
- Alexion Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The objectives of this time-to-event study were to assess the efficacy and safety of eculizumab as compared with placebo in participants with neuromyelitis optica spectrum disorder (NMOSD) who were anti-aquaporin-4 (AQP4) antibody-positive.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Eculizumab | Induction Phase: 900 mg IV weekly for 4 weeks, followed by 1200 mg for the fifth dose; Maintenance Phase: 1200 mg IV every 2 weeks |
| DRUG | Placebo | Induction Phase: matching placebo (900 mg) IV weekly for 4 weeks, followed by matching placebo (1200 mg) for the fifth dose; Maintenance Phase: matching placebo (1200 mg) IV every 2 weeks |
Timeline
- Start date
- 2014-04-11
- Primary completion
- 2018-07-17
- Completion
- 2018-07-17
- First posted
- 2013-07-04
- Last updated
- 2019-06-26
- Results posted
- 2019-06-26
Locations
70 sites across 18 countries: United States, Argentina, Australia, Croatia, Czechia, Denmark, Germany, Hong Kong, Italy, Japan, Malaysia, Russia, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom
Source: ClinicalTrials.gov record NCT01892345. Inclusion in this directory is not an endorsement.