CompletedPhase 3

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

United States117 participantsStarted 2014-11-12

Plain-language summary

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).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

Count Of Participants With Treatment-Emergent Adverse Events

Timeframe: Day 1 (after dosing) through End of Study (Week 208)

Trial details

NCT IDNCT02301624

SponsorAlexion Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-01-15

Results submitted2019-12-09

View on ClinicalTrials.gov More Refractory Generalized Myasthenia Gravis trials