Clinical trial · Interventional
Long Term Safety Study of Amifampridine Phosphate in MuSK-MG (Muscle Specific Tyrosine Kinase Myasthenia Gravis)
Long Term Safety Study of Amifampridine Phosphate in Patients With MuSK Antibody Positive and AChR (Acetylcholine Receptor) Antibody Positive Myasthenia Gravis
NCT03579966CI-TRIAL-00076829terminatedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of measure appropriate data (MG-ADL).
Summary
Brief summary (as posted)
Evaluate the long-term safety of amifampridine phosphate in patients with MuSK antibody positive and AChR antibody positive myasthenia gravis.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| AChR Myasthenia Gravis | — | UNRESOLVED | — |
| Myasthenia Gravis, MuSK | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Amifampridine Phosphate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- amifampridine phosphate
- description
- tablets equivalent to 10mg amifampridine, 3 to 4 times per day. Initially, the daily amifampridine doses were to be the doses that were determined at the end of the Run-in Period from the MSK-002 study. The usual range was from 30 to 80 mg total daily dose, given in three (3) or four (4) doses, with no single dose \> 20 mg
- interventionNames
- Drug: Amifampridine Phosphate
Primary outcomes (1)
- measure
- Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability)
- timeFrame
- over 39 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria 1. Participated in the MSK-002 study 2. Willing and able to provide written informed consent after the nature of the study has been explained and before the start of any research-related procedures. 3. Female patients of childbearing potential must have a negative pregnancy test (urine human chorionic gonadotropin \[HCG\] at the end of MSK-002 study); and must practice an effective, reliable contraceptive regimen during the study and for up to 30 days following discontinuation of treatment. 4. Ability to participate in the study based on overall health of the patient and disease prognosis, as applicable, in the opinion of the Investigator; and able to comply with all requirements of the protocol, including completion of study questionnaires. Individuals who met any of the exclusion criteria in the original protocol or those listed below are not eligible to participate in the study: 1. Epilepsy and currently on medication. 2. Clinically significant abnormalities in 12 lead ECG, in the opinion of the Investigator. 3. Breastfeeding or pregnant at Screening or planning to become pregnant at any time during the study. 4. Intolerable amifampridine-related side effects 5. Treatment with an investigational drug (other than amifampridine) or device while participating in this study. 6. Any medical condition that, in the opinion of the Investigator, might interfere with the patient's participation in the study, poses an added risk for the patient, or confound the assessment of the patient.
References
Publications (0)
Data not yet available
No reference posted for this study.