Start of open label extension study COURAGE ALS OLE for ALS patients completing COURAGE-ALS study.
Cytokinetics, Incorporated announced the start of COURAGE-ALS OLE (Clinical Outcomes Using Reldesemtiv on ALSFRS-R in a Global Evaluation in ALS Open Label Extension), an open-label extension clinical study designed to assess the long-term safety and tolerability of reldesemtiv in people with amyotrophic lateral sclerosis (ALS).
Patients will be eligible for COURAGE-ALS OLE after completing their participation in COURAGE-ALS, the Phase III clinical trial of reldesemtiv, a next-generation fast skeletal muscle troponin activator (FSTA) for the potential treatment of ALS.
COURAGE-ALS OLE: Clinical Study Design : COURAGE-ALS OLE is an open-label extension clinical study of reldesemtiv in people with ALS who have completed participation in COURAGE-ALS. Following enrollment in COURAGE-ALS OLE, participants will continue to receive 300 mg of reldesemtiv dosed orally twice daily for 48 weeks after which they may transition into the Managed Access Program. The primary endpoint is the incidence of adverse events. Secondary endpoints include the time to the first occurrence of respiratory insufficiency or death, time to the first hospitalization, combined assessment of change in ALSFRS-R total score, time to onset of respiratory insufficiency, and survival time, changes in ALSFRS-R total score, and the slope of changes in ALSFRS-R total score.
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