Stopped: Sponsor Decision
This study is an open-label extension to evaluate the safety and tolerability of long-term dosing of Losmapimod in patients with FSHD1 who participated in the ReDux4 study.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Number of Participants Reporting Serious Treatment Emergent Adverse Events (Serious TEAEs) and TEAEs
Timeframe: Up to 57 months
Number of Participants With Clinically Significant Changes in Chemistry Parameters
Timeframe: Up to 57 months
Number of Participants With Clinically Significant Changes in Hematology Parameters
Timeframe: Up to 57 months
Number of Participants With Clinically Significant Changes in Serum Coagulation Parameters
Timeframe: Up to 57 months
Number of Participants With Clinically Significant Changes in Urinalysis
Timeframe: Up to 57 months
Number of Participants With Clinically Significant Changes in Vital Parameters
Timeframe: Up to 57 months
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Parameters
Timeframe: Up to 57 months
Number of Participants With Clinically Significant Changes in Physical Examinations
Timeframe: Up to 57 months