Safety and Efficacy of Eculizumab in Refractory Generalized Myasthenia Gravis (REGAIN Study)
Study Identifier:
ECU-MG-301
ClinicalTrials.gov Identifier:
EudraCT Identifier:
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Study Complete
Study Details
Medical Condition
- Refractory Generalized Myasthenia Gravis
Study Drug
- Biological: Eculizumab
- Drug: Placebo
Date
Dec 2013 - Feb 2016
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
- Male or female patients ≥18 years old
- Diagnosis of MG made by the following tests:
- Positive serologic test for anti-AChR Abs as confirmed at screening, and
- One of the following:
- History of abnormal neuromuscular transmission test demonstrated by single-fiber electromyography (SFEMG) or repetitive nerve stimulation, or
- History of positive anticholinesterase test, e.g. edrophonium chloride test, or
- Subject has demonstrated improvement in MG signs on oral cholinesterase inhibitors, as assessed by the treating physician.
- MGFA Clinical Classification Class II to IV at screening.
- MG-ADL total score must be ≥6 at screening and Randomization (Day 1).
- Subjects who have:
- Failed treatment with at least two immunosuppressive agents. Or,
- Failed treatment with at least one immunosuppressive agent and require chronic plasma exchange or IVIg
Exclusion Criteria
- History of thymoma or other neoplasms of the thymus
- History of thymectomy within 12 months prior to screening
- MGFA Class I or MG crisis at screening (MGFA Class V)
- Use of rituximab within 6 months prior to screening
- Use of IVIg or PE within 4 weeks prior to Randomization (Day 1)
Sex
Female & Male
Age
18+ years
Study Details
Medical Condition
- Refractory Generalized Myasthenia Gravis
Study Drug
- Biological: Eculizumab
- Drug: Placebo
Date
Dec 2013 - Feb 2016
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
- Male or female patients ≥18 years old
- Diagnosis of MG made by the following tests:
- Positive serologic test for anti-AChR Abs as confirmed at screening, and
- One of the following:
- History of abnormal neuromuscular transmission test demonstrated by single-fiber electromyography (SFEMG) or repetitive nerve stimulation, or
- History of positive anticholinesterase test, e.g. edrophonium chloride test, or
- Subject has demonstrated improvement in MG signs on oral cholinesterase inhibitors, as assessed by the treating physician.
- MGFA Clinical Classification Class II to IV at screening.
- MG-ADL total score must be ≥6 at screening and Randomization (Day 1).
- Subjects who have:
- Failed treatment with at least two immunosuppressive agents. Or,
- Failed treatment with at least one immunosuppressive agent and require chronic plasma exchange or IVIg
Exclusion Criteria
- History of thymoma or other neoplasms of the thymus
- History of thymectomy within 12 months prior to screening
- MGFA Class I or MG crisis at screening (MGFA Class V)
- Use of rituximab within 6 months prior to screening
- Use of IVIg or PE within 4 weeks prior to Randomization (Day 1)
Protocol Summary
The purpose of this study is to determine if eculizumab is safe and effective for the treatment of refractory generalized Myasthenia Gravis.
Trial Locations
Location
Status
Location
University of Alabama
Birmingham, Alabama, United States, 35233
Status
N/A
Location
University of California San Francisco-Fresno
Fresno, California, United States, 93720
Status
N/A
Location
University of Southern California
Los Angeles, California, United States, 90033
Status
N/A
Location
University of California-Irvine
Orange, California, United States, 92868
Status
N/A
Location
University of California Davis Health System
Sacramento, California, United States, 95765
Status
N/A
Location
California Pacific Medical Center
San Francisco, California, United States, 94115
Status
N/A
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