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Study to Evaluate Amifampridine Phosphate in Patients With MuSK-MG

Myasthenia Gravis, Generalized Clinical Trial

Official title:
A Randomized, Placebo-control, Parallel Group Study to Evaluate the Effect of Amifampridine Phosphate in Patients With MuSK Antibody Positive Myasthenia Gravis, and a Sample of AChR Antibody Positive Myasthenia Gravis Patients

Clinical Trial Summary

Efficacy and safety of amifampridine phosphate in improving the activities of daily living for patients with antibody positive MuSK myasthenia gravis.

Clinical Trial Description

Randomized, double-blind, placebo-controlled, parallel group study is designed to evaluate the safety, tolerability and efficacy of amifampridine phosphate in patients with MuSK-MG. In addition, a sample of AChR-MG patients will be assess for efficacy and safety of amifampridine phosphate. Planned duration of participation for each patient is at least 38 days, excluding the screening period. Eligible patients will be titrated to an efficacious dose of amifampridine phosphate and those who demonstrate improvement will be randomized to either placebo or amifampridine, in a double-blind fashion, for 10 days. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03304054
Study type Interventional
Source Catalyst Pharmaceuticals, Inc.
Contact
Status Completed
Phase Phase 3
Start date April 18, 2018
Completion date March 15, 2020
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