Long Term Safety Study of Amifampridine Phosphate in MuSK-MG (Muscle Specific Tyrosine Kinase Myasthenia Gravis)
NCT03579966 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 63
Last updated 2024-05-07
Summary
Evaluate the long-term safety of amifampridine phosphate in patients with MuSK antibody positive and AChR antibody positive myasthenia gravis.
Conditions
- Myasthenia Gravis, MuSK
- AChR Myasthenia Gravis
Interventions
- DRUG
-
Amifampridine Phosphate
tablets equivalent to 10mg amifampridine, titrated to an efficacious and tolerable dose, 3 to 4 times a day
Sponsors & Collaborators
-
Catalyst Pharmaceuticals, Inc.
lead INDUSTRY
Principal Investigators
-
Renato Mantegazza, MD · Carlo Besta Neurological Institute
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-06-11
- Primary Completion
- 2022-08-05
- Completion
- 2022-08-05
- FDA Drug
- Yes
Countries
- United States
- Italy
Study Locations
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