NCT04264442Phase 2Terminated

Efficacy and Safety of Losmapimod in Treating Subjects With Facioscapulohumeral Muscular Dystrophy (FSHD) With Open-Label Extension (OLE)

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2024-11-07Actual

Enrollment · participants76Actual

Source updated2025-09-30Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

Facioscapulohumeral Muscular Dystrophy (FSHD)

Treatments or interventions studied

LosmapimodDrug

Primary outcomes · main study measures

Read the study measures

measure: Number of Participants Reporting Serious Treatment Emergent Adverse Events (Serious TEAEs) and TEAEs; description: A TEAE is an adverse event that begins on or after the first dose of study drug and on or before the stop of study drug plus 7 days or begins before the first dose of study drug and worsens on or after the first dose of study drug and on or before the stop of study drug plus 7 days. An adverse event with completely missing onset and end dates was considered as TEAE. An adverse event with missing onset date but the end date is on or after the first dose of study drug and before the stop of study drug plus 7 days was considered a TEAE.; timeFrame: Up to 57 months; measure: Number of Participants With Clinically Significant Changes in Chemistry Parameters; description: Blood samples were collected for the analysis of chemistry parameters: Glucose, sodium, potassium, calcium, inorganic phosphate, total protein, albumin, blood urea nitrogen, creatinine, total bilirubin, alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase and creatine phosphokinase.; timeFrame: Up to 57 months; measure: Number of Participants With Clinically Significant Changes in Hematology Parameters; description: Blood samples were collected for the analysis of hematology parameters: hemoglobin (including mean corpuscular volume), mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, hematocrit, red blood cell count, total white blood cell count, platelet count. Differential blood counts, including basophils, eosinophils, neutrophils, lymphocytes, and monocytes; timeFrame: Up to 57 months; measure: Number of Participants With Clinically Significant Changes in Serum Coagulation Parameters; description: Blood samples were collected for the analysis of Serum coagulation parameters: International normalized ratio, prothrombin time, partial thromboplastin time.; timeFrame: Up to 57 months; measure: Number of Participants With Clinically Significant Changes in Urinalysis; description: Urine samples were collected for the analysis of urinalysis parameters: Leucocytes, blood, nitrite, protein, urobilinogen, bilirubin, pH, specific gravity, ketones, glucose.; timeFrame: Up to 57 months; measure: Number of Participants With Clinically Significant Changes in Vital Parameters; description: Vital parameters including pulse rate, respiration rate, blood pressure, and temperature were measured in seated or recumbent for at least 5 minutes. Data for number of participants with abnormal clinically significant changes for vital signs have been presented.; timeFrame: Up to 57 months; measure: Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Parameters; description: Twelve-lead ECGs was performed after participants has been recumbent for at least 5 minutes.; timeFrame: Up to 57 months; measure: Number of Participants With Clinically Significant Changes in Physical Examinations; description: Physical examinations included an evaluation of body systems, including but not limited to the following: skin; head, eyes, ears, nose, and throat; respiratory system; cardiovascular system; abdomen (liver, spleen); lymph nodes; neurological system; and musculoskeletal system.; timeFrame: Up to 57 months

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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