Long Term Safety Study of Amifampridine Phosphate in MuSK-MG (Muscle Specific Tyrosine Kinase Myasthenia Gravis)

• Register: ClinicalTrials.gov
• Last refreshed on: 24 April 2023
• Main ID: NCT03579966
• Date of registration: 05/06/2018
• Prospective Registration: Yes
• Primary sponsor: Catalyst Pharmaceuticals, Inc.
• Public title: Long Term Safety Study of Amifampridine Phosphate in MuSK-MG (Muscle Specific Tyrosine Kinase Myasthenia Gravis)
• Scientific title: Long Term Safety Study of Amifampridine Phosphate in Patients With MuSK Antibody Positive and AChR (Acetylcholine Receptor) Antibody Positive Myasthenia Gravis
• Date of first enrolment: July 1, 2018
• Target sample size: 70
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT03579966
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: Renato Mantegazza, MD
• Affiliation: Carlo Besta Neurological Institute

Key inclusion & exclusion criteria

Inclusion Criteria:

- Participated in the MSK-002 study

Exclusion Criteria:

- Epilepsy and currently on medication

- Clinically significant abnormalities in ECG, in the opinion of the Investigator



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Myasthenia Gravis, MuSK

Intervention(s)

Drug: Amifampridine Phosphate

Primary Outcome(s)

Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [Time Frame: over 21 months]

Secondary ID(s)

MSK-003

Source(s) of Monetary Support

Please refer to primary and secondary sponsors