Clinical trial · Interventional
Phase 3 Study to Evaluate Efficacy of Amifampridine Phosphate in Lambert-Eaton Myasthenic Syndrome (LEMS)
A Phase 3, Double-Blind, Placebo-controlled, Randomized, Parallel-Group Study to Evaluate the Efficacy and Safety of Amifampridine Phosphate in Patients With Lambert-Eaton Myasthenic Syndrome
NCT02970162CI-TRIAL-00036263completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study evaluates the effect of withdrawing amifampridine phosphate treatment from patients with LEMS. One half of the patients will continue to receive amifampridine phosphate and the other half will receive placebo, during this double-blind study.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lambert-Eaton Myasthenic Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Amifampridine Phosphate | Drug | — | UNRESOLVED |
| Placebo Oral Tablet | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- amifampridine phosphate
- description
- amifampridine phosphate 10 mg (amifampridine equivalent) by mouth, 30 to 80 mg total daily dose, 3 to 4 times per day for 4 days
- interventionNames
- Drug: Amifampridine Phosphate
- type
- PLACEBO_COMPARATOR
- label
- placebo (for amifampridine phosphate)
- description
- placebo by mouth 3 to 4 times per day for 4 days
- interventionNames
- Drug: Placebo Oral Tablet
Primary outcomes (2)
- measure
- Quantitative Myasthenia Gravis (QMG) Score
- timeFrame
- change from baseline in QMG score at end of day 4
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male or female ≥18 years of age and currently receiving amifampridine phosphate for LEMS. 2. Diagnosis of LEMS by antibody testing or electromyography (EMG). 3. Completion of anti-cancer treatment at least 3 months (90 days) prior to Screening. 4. If receiving peripherally acting cholinesterase inhibitors (e.g. pyridostigmine), a stable dose of cholinesterase inhibitors is required for at least 7 days prior to randomization and throughout the study. 5. If receiving permitted oral immunosuppressants (prednisone or other corticosteroid), a stable dose is required for at least 30 days prior to randomization and throughout the study. 6. Female patients of childbearing potential must practice an effective, reliable contraceptive regimen during the study. 7. Able to perform all study procedures and assessments. 8. Willing and able to travel to study site and attend all clinic study visits. 9. Willing and able to provide written informed consent. Exclusion Criteria: 1. Clinically significant long corrected QT (QTc) interval on ECG in previous 12 months. 2. Seizure disorder. 3. Active brain metastases. 4. Unable to ambulate. 5. Pregnant or lactating females. 6. Any other condition which, in the opinion of the Investigator, might interfere with the patient's participation in the study or confound the assessment of the patient.
References
Publications (0)
Data not yet available
No reference posted for this study.