CK-2127107 is a novel fast skeletal muscle troponin activator being developed as a potential treatment for people living with SMA and certain other debilitating neuromuscular and non-neuromuscular conditions associated with muscle weakness and/or muscle fatigue. CK 2127107 is liquid form taken twice a day by mouth.
This first clinical trial of this investigational drug in patients with spinal muscular atrophy (SMA) is a Phase 2, double-blind, randomized, placebo-controlled, multiple dose study of the investigational agent, CK-2127107, in patients with SMA, Types II, III, or IV, ages 12 and older. It is designed to assess the effect of 8 weeks of dosing of CK-2127107 on measures of muscle function and fatigue in both ambulatory and non-ambulatory patients with SMA. The plasma concentration of CK-2127107 will be measured at selected time points and the plasma concentrations obtained may be used to understand the response to different concentrations. The clinical trial is sponsored by Cytokinetics, a biopharmaceutical company in South San Francisco, California, in collaboration with its partner Astellas, a pharmaceutical company in Tokyo, Japan.
In this clinical trial, eligible patients with SMA will randomly be assigned to receive either CK-2127107 or placebo, and neither the participant nor the site Investigator will know which study treatment the patient is receiving. The primary objective of the study is to evaluate measures of skeletal and respiratory muscle function. In addition, safety, tolerability and levels of CK-2127107 will be monitored.
More information about this clinical trial can be found at www.clinicaltrials.org using the following link: https://clinicaltrials.gov/ct2/show/NCT02644668. The clinicaltrials.gov identifier is NCT02644668.
The following sites are currently recruiting patients. As additional sites are added this list will be updated on www.clinicaltrials.gov:
United States, California
Pediatric Neuromuscular Clinic Stanford University
Palo Alto, California, United States, 94304
Contact: Angelica Martinez, (650) 725-4341, [email protected]
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Contact: Ayla McCalley, (913) 945-9937, [email protected]
United States, Maryland
Johns Hopkins Hospital Institute for Clinical and Translational Research Pediatric Clinical Research Unit
Baltimore, Maryland, United States, 21287
Contact: Anges Kind Rennie, (443) 287-6294
United States, Massachusetts
Boston Children’s Hospital
Boston, Massachusetts, United States, 02115
Contact: Heather M. Fournier, (617) 355-2752 [email protected]
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Contact: Traci Christenson, [email protected]
United States, Ohio
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Contact: Louisa Mezache, (614) 685-3030, [email protected]
United States, Utah
The University of Utah, Clinical Neurosciences Center
Salt Lake City, Utah, United States, 84132
Contact: Andy Rivera, (801) 581-5522, [email protected]