STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTS

Phase 1

• Conditions: Generalized Myasthenia Gravis; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]; MedDRA version: 16.1Level: HLTClassification code 10071942Term: Myasthenia gravis and related conditionsSystem Organ Class: 100000004859

• Registration Number: EUCTR2013-003589-15-ES
• Lead Sponsor: Alexion Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12-27
• Last Update Posted: 30 May 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

- Male or female subjects ?18 years old
- Diagnosis of MG
- MGFA Clinical Classification Class II to IV at screening
- MG-ADL total score must be ?6 at screening
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 83
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 9

Exclusion Criteria

- History of thymoma or other neoplasms of thymus
- History of thymectomy within 12 months prior to screening
- Weakness only affecting ocular or peri-ocular muscles (MGFA Class I)
- MG crisis at screening (MGFA Class V)
- Pregnancy or lactation
- Unresolved meningococcal infection

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified