Phase 3 Study to Evaluate Efficacy of Amifampridine Phosphate in Lambert-Eaton Myasthenic Syndrome (LEMS)
Completed · Phase 3 · Has a placebo group
Conditions studied: Lambert-Eaton Myasthenic Syndrome
In brief
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.
Key facts
- Study ID
- NCT02970162
- Run by
- Catalyst Pharmaceuticals, Inc.
- People needed
- 26
- Starts
- 2016-11-01
- Expected to finish
- 2017-10-01
- Last updated by the study team
- 2018-12-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
- Willing and able to provide written informed consent.
You may not qualify if…
- Clinically significant long corrected QT (QTc) interval on ECG in previous 12 months.
- Seizure disorder.
- Active brain metastases.
- Unable to ambulate.
- Pregnant or lactating females.
- 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.
Where it is running
- UCLA — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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