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

Completed · Phase 3 · Has a placebo group

Conditions studied: Refractory Generalized Myasthenia Gravis

In brief

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).

Key facts

Study ID

NCT02301624

Run by

Alexion Pharmaceuticals, Inc.

People needed

117

Starts

2014-11-12

Expected to finish

2019-01-15

Last updated by the study team

2020-02-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant has completed Study ECU-MG-301.
• Participant has given written informed consent.
• Participant was willing and able to comply with the protocol requirements for the duration of the study.
• Female participant of childbearing potential must have had a negative pregnancy test (serum human chorionic gonadotropin). All participants were required to practice an effective, reliable, and medically approved contraceptive regimen during the study and for up to 5 months following discontinuation of treatment.

You may not qualify if…

• Participants who withdrew from Study ECU-MG-301 as a result of an adverse event related to study drug.
• Female participants who were pregnant, breastfeeding, or intended to conceive during the course of the study.
• Unresolved meningococcal infection
• Hypersensitivity to murine proteins or to one of the excipients of eculizumab
• Any medical condition or circumstances that, in the opinion of the investigator, might have interfered with the participant's participation in the study, posed any added risk for the participant, or confounded the assessment of the participants.

Where it is running

• Study site — Los Angeles, California, United States
• Study site — Orange, California, United States
• Study site — Palo Alto, California, United States
• Study site — San Francisco, California, United States
• Study site — New Haven, Connecticut, United States
• Study site — Jacksonville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Springfield, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Iowa City, Iowa, United States
• Study site — Kansas City, Kansas, United States
• Study site — Baltimore, Maryland, United States
• Study site — Baltimore, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Burlington, Massachusetts, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Durham, North Carolina, United States
• Study site — Columbus, Ohio, United States
• Study site — Portland, Oregon, United States
• Study site — San Antonio, Texas, United States
• Study site — Burlington, Vermont, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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