The purpose of this study is to assess the long-term safety and tolerability of reldesemtiv in patients with ALS who have successfully completed dosing in the Phase 3 clinical trial, CY 5031 (also known as COURAGE-ALS)
CY 5032 is an open-label extension (OLE) study of the selective fast skeletal muscle troponin activator, reldesemtiv, in patients with ALS who finished dosing (through Week 48) in CY 5031 (COURAGE-ALS). Approximately 400 patients from the sites that participated in CY 5031 are expected to be enrolled in the open-label extension, CY 5032. Following enrollment, patients will continue dosing with reldesemtiv, 300 mg twice a day for a 600 mg total daily dose (TDD) for a period of 48 weeks. At the end of 48 weeks, patients may transition to a reldesemtiv Managed Access Program (MAP) if the treating physician agrees to participate in the program.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
71
Oral tablet
Long-term Safety and Tolerability
Incidence of treatment-emergent adverse events
Time frame: Baseline to Week 34 (time the study was terminated prematurely)
Long-term Effect of Reldesemtiv on ALSFRS-R Functional Outcomes
Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) total scores. ALSFRS-R total score range is from 0 to 48. A score of 48 reflects normal function.
Time frame: Baseline to Week 32 (last timepoint before study was terminated prematurely)
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St. Joseph's Hospital & Medical Center - Barrow Neurological Institute
Phoenix, Arizona, United States
University of California Irvine - ALS & Neuromuscular Center
Orange, California, United States
California Pacific Medical Center - Forbes Norris MDA/ALS Research Center
San Francisco, California, United States
University of Colorado Hospital Anschutz Outpatient Pavilion
Aurora, Colorado, United States
George Washington Medical Faculty Associates
Washington D.C., District of Columbia, United States
University of Florida
Jacksonville, Florida, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
University of South Florida - Carol and Frank Morsani Center for Advanced Health Care
Tampa, Florida, United States
Indiana University IU Health Neuroscience Center
Indianapolis, Indiana, United States
The University of Kansas Medical Center
Kansas City, Kansas, United States
...and 31 more locations