Trial · NCT03579966

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

NCT03579966, Phase 3, Terminated, Catalyst Pharmaceuticals, Inc.; results first posted 2024-05-07

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Long Term Safety Study of Amifampridine Phosphate in MuSK-MG (Muscle Specific Tyrosine Kinase Myasthenia Gravis). Trials, record NCT03579966. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03579966

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Long Term Safety Study of Amifampridine Phosphate in MuSK-MG (Muscle Specific Tyrosine Kinase Myasthenia Gravis)
NCT number: NCT03579966
Status: Terminated
Phases: Phase 3
Enrollment: 63 participants, actual
Lead sponsor: Catalyst Pharmaceuticals, Inc.
Conditions: Myasthenia Gravis, MuSK, AChR Myasthenia Gravis
Interventions: Amifampridine Phosphate
First posted: 2018-07-09
Last updated: 2024-05-07
Results first posted: 2024-05-07
Limitations and caveats: The study was terminated due to lack of measure appropriate data. The analysis of the MG-ADL score was removed in Statistical Analysis Plan (SAP), dated 21FEB2023.

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability)	over 39 months	Evaluate the long-term safety and tolerability of amifampridine phosphate through the number of patients with treatment-emergent adverse events mapped to the Medical Dictionary for Regulatory Activities (MedDRA) SOCs and PTs. \[ Time Frame: over 39 months \] Descriptive statistics will be used to summarize study data.

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability)	over 39 months		Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group1

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability)	Treatment Emergent Adverse Events		58		Participants

Source ClinicalTrials.gov

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Amifampridine Phosphate	63
Overall Study	COMPLETED	Amifampridine Phosphate	3
Overall Study	NOT COMPLETED	Amifampridine Phosphate	60

Source ClinicalTrials.gov

Adverse events54

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Cataract	Ear and labyrinth disorders	Serious Adverse Event	4	63	4
other	Diplopia	Ear and labyrinth disorders	Serious Adverse Event	3	63	3
other	Vitreous Floaters	Eye disorders	Serious Adverse Event	2	63	2
other	Abdominal Pain	Gastrointestinal disorders	Serious Adverse Event	2	63	2
other	Abdominal Pain Upper	Gastrointestinal disorders	Serious Adverse Event	5	63	5
other	Diarrhea	Gastrointestinal disorders	Serious Adverse Event	2	63	2
other	Hypoasthesia Oral	Gastrointestinal disorders	Serious Adverse Event	4	63	4
other	Nausea	Gastrointestinal disorders	Serious Adverse Event	4	63	4
other	Paresthesia Oral	Gastrointestinal disorders	Serious Adverse Event	15	63	15
other	Vomiting	Gastrointestinal disorders	Serious Adverse Event	4	63	4

1 to 10 of 54Source ClinicalTrials.gov

See all 54 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Serious Adverse Event	0	63
Total, other adverse events	Serious Adverse Event	58	63
Total, serious adverse events	Serious Adverse Event	14	63

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03579966

GET https://conductscience.org/api/trials/v1/NCT03579966/events?page=2

API reference For AI assistants