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Clinical Trials/EUCTR2013-003589-15-IT
EUCTR2013-003589-15-ITActive, not recruitingPhase 1

A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OFECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)

Alexion Pharmaceuticals, Inc.0 sites92 target enrollmentStarted: December 17, 2013Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
92
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

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

Investigators

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EUCTR2013-003589-15-CZAlexion Pharmaceuticals, Inc.92