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Extension Study of ECU-MG-301 to Evaluate Safety and Efficacy of Eculizumab in Refractory Generalized Myasthenia Gravis

NCT02301624 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 117

Last updated 2020-02-05

Study results available
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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).

Conditions

  • Refractory Generalized Myasthenia Gravis

Interventions

BIOLOGICAL

Eculizumab

Intravenous administration of eculizumab.

DRUG

Placebo

Intravenous administration of matching placebo. Participants received placebo only during the Blind Induction Phase.

Sponsors & Collaborators

  • Alexion Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Marcus Yountz, MD · Alexion Pharmaceuticals, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-12
Primary Completion
2019-01-15
Completion
2019-01-15

Countries

  • United States
  • Argentina
  • Belgium
  • Brazil
  • Canada
  • Czechia
  • Denmark
  • Finland
  • Hungary
  • Italy
  • Japan
  • Netherlands
  • South Korea
  • Spain
  • Sweden
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02301624 on ClinicalTrials.gov