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Phase 3 Study to Evaluate Efficacy of Amifampridine Phosphate in Lambert-Eaton Myasthenic Syndrome (LEMS)

This study is currently recruiting participants.
See Contacts and Locations
Verified January 2017 by Catalyst Pharmaceuticals, Inc.
Sponsor:
Information provided by (Responsible Party):
Catalyst Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT02970162
First received: November 16, 2016
Last updated: January 11, 2017
Last verified: January 2017
November 16, 2016
January 11, 2017
November 2016
July 2017   (Final data collection date for primary outcome measure)
  • Quantitative Myasthenia Gravis (QMG) score [ Time Frame: change from baseline in QMG score at end of day 4 ]
  • Subject Global Impression (SGI) score [ Time Frame: change from baseline in SGI score at end of day 4 ]
Same as current
Complete list of historical versions of study NCT02970162 on ClinicalTrials.gov Archive Site
Clinician's Global Impression of Improvement (CGI-I) [ Time Frame: change from baseline in CGI-I score at end of day 4 ]
Same as current
Triple Timed Up and Go walk test (3TUG) [ Time Frame: change from baseline in time to complete test on day 4 ]
Same as current
 
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Lambert-Eaton Myasthenic Syndrome
  • Drug: Amifampridine Phosphate
  • Drug: Placebo Oral Tablet
  • Experimental: amifampridine phosphate
    amifampridine phosphate 10 mg (amifampridine equivalent) by mouth, 30 to 80 mg total daily dose, 3 to 4 times per day for 4 days
    Intervention: Drug: Amifampridine Phosphate
  • Placebo Comparator: placebo (for amifampridine phosphate)
    placebo by mouth 3 to 4 times per day for 4 days
    Intervention: Drug: Placebo Oral Tablet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
28
September 2017
July 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Adriana Manari 305-420-3217 amanari@catalystpharma.com
Contact: Jonathan Rubine, MD 305-420-3233 jrubine@catalystpharma.com
United States
 
 
NCT02970162
LMS-003
No
Not Provided
No
Not Provided
Catalyst Pharmaceuticals, Inc.
Catalyst Pharmaceuticals, Inc.
Not Provided
Principal Investigator: Perry Shieh, MD, PhD University of California, Los Angeles
Catalyst Pharmaceuticals, Inc.
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP