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

Study results available
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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

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03579966 on ClinicalTrials.gov