Status:
COMPLETED
A Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults With Generalized Myasthenia Gravis
Lead Sponsor:
Momenta Pharmaceuticals, Inc.
Conditions:
Generalized Myasthenia Gravis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, and efficacy of M281 administered to participants with generalized myasthenia gravis (gMG) who have an insufficient clinical response...
Eligibility Criteria
Inclusion
- Participants must be ≥18 years of age with a documented history of Generalized Myasthenia Gravis (gMG) and clinical signs/symptoms of gMG, not pregnant or breastfeeding, and no history of any neurologic disorder other than MG that might interfere with the accuracy of study assessments.
- Additional, more specific criteria are defined in the protocol.
Exclusion
Key Trial Info
Start Date :
April 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 25 2020
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT03772587
Start Date
April 10 2019
End Date
June 25 2020
Last Update
June 27 2023
Active Locations (61)
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1
Momenta Investigational Site
Phoenix, Arizona, United States, 85013
2
Momenta Investigational Site
Tucson, Arizona, United States, 85724
3
Momenta Investigational Site
Los Angeles, California, United States, 90048
4
Momenta Investigational Site
Orange, California, United States, 92868