EXTENSION STUDY OF ECU-MG-301 TO EVALUATE ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) SUBJECTS
- Conditions
- Generalized Myasthenia GravisMedDRA version: 20.0 Level: HLT Classification code 10071942 Term: Myasthenia gravis and related conditions System Organ Class: 100000004859Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2013-002191-41-FI
- Lead Sponsor
- Alexion Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 92
1. Subject has completed the ECU-MG-301 trial.
2. Subject has given written informed consent.
3. Subject is willing and able to comply with the protocol requirements
for the duration of the trial.
4. Female subjects of child-bearing potential must have a negative
pregnancy test (serum human chorionic gonadotropin [HCG]). All
subjects must practice an effective, reliable and medically approved
contraceptive regimen during the trial and for up to 5 months following
discontinuation of treatment.
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
1. Subjects who withdrew from the ECU-MG-301 trial as a result of an AE
related to trial drug.
2. Female subjects who are pregnant, breastfeeding or intend to
conceive during the course of the trial.
3. Any medical condition or circumstances that, in the opinion of the
Investigator, might interfere with the subject's participation in the trial,
pose any added risk for the subject, or confound the assessment of the
subjects.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method