Phase 3 Study to Evaluate Efficacy of Amifampridine Phosphate in Lambert-Eaton Myasthenic Syndrom… (NCT02970162) | Clinical Trial Compass
CompletedPhase 3
Phase 3 Study to Evaluate Efficacy of Amifampridine Phosphate in Lambert-Eaton Myasthenic Syndrome (LEMS)
United States26 participantsStarted 2016-11
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female ≥18 years of age and currently receiving amifampridine phosphate for LEMS.
✓. Diagnosis of LEMS by antibody testing or electromyography (EMG).
✓. Completion of anti-cancer treatment at least 3 months (90 days) prior to Screening.
✓. 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.
✓. 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.
✓. Female patients of childbearing potential must practice an effective, reliable contraceptive regimen during the study.
✓. Able to perform all study procedures and assessments.
✓. Willing and able to travel to study site and attend all clinic study visits.
Exclusion criteria
✕. Clinically significant long corrected QT (QTc) interval on ECG in previous 12 months.
✕. Seizure disorder.
✕. Active brain metastases.
✕. Unable to ambulate.
What they're measuring
1
Quantitative Myasthenia Gravis (QMG) Score
Timeframe: change from baseline in QMG score at end of day 4
2
Subject Global Impression (SGI) Score
Timeframe: change from baseline in SGI score at end of day 4
✕. 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.