At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 93 enrolled
Drug / intervention
Amifampridine Phosphate +1 moredrug
Likely dose
Amifampridine Phosphate 10mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Amifampridine Phosphate and Placebo Oral Tablet for Myasthenia Gravis, Generalized. Completed, enrolled 93 participants across 2 sites.
Detailed Summary
Efficacy and safety of amifampridine phosphate in improving the activities of daily living for patients with antibody positive MuSK myasthenia gravis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyasthenia Gravis, Generalized
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedOct 2017
Enrollment StartApr 2018
Primary CompletionJan 2020
Study CompletionMar 2020
TodayJul 2026
First PostedOct 6, 2017
Enrollment StartApr 18, 2018
Primary CompletionJan 31, 2020
Study CompletionMar 15, 2020
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 8.7 years ago
Interventions
Amifampridine Phosphatedrug
tablets equivalent to 10mg amifampridine, titrated to an efficacious and tolerable dose, 3 to 4 times a day
Placebo Oral Tabletdrug
tablets matching amifampridine phosphate, 3 to 4 times a day