NCT04004000Phase 2Terminated

Evaluation of Safety, Tolerability, and Changes in Biomarker and Clinical Outcome Assessments of Losmapimod for FSHD1 With Extension

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.

Open ClinicalTrials.gov record CSV export · Pro

Primary completion2024-10-31Actual

Enrollment · participants14Actual

Source updated2025-12-02Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

Pro unlocks the full available history and CSV export. View Pro features

Posted 2025-12-02 · 1 field changed

Main study measure wording changed

Text changed; whether the study measures changed has not been verified. Saved text may be shortened.

Compare wording

− Before

Measure: ~~Main~~ ~~Study~~ ~~and~~ ~~Extension Study -~~ Treatment-Emergent Adverse Events

+ After

Measure: Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs Measure: Number of Participants With Clinically Significant Changes in Chemistry Parameters Measure: Number of Participants With Clinically Significant Changes in Hematology Parameters Measure: Number of Participants With Clinically Significant Changes in Serum Coagulation Parameters

Check registry source

Study details

Conditions studied

Facioscapulohumeral Muscular Dystrophy 1

Treatments or interventions studied

LosmapimodDrug

Primary outcomes · main study measures

Read the study measures

measure: Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs; description: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A TEAE is an AE that begins on or after the first dose of study drug and before the stop of study drug + 7 days or begins before the first dose of study drug and worsens on or after the first dose of study drug and before the stop of study drug + 7 days. A Serious adverse event (SAE) is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment.; timeFrame: Up to 68 Weeks; 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, uric acid, total bilirubin, alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, lactate dehydrogenase and creatine phosphokinase.; timeFrame: Up to 68 Weeks; 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 68 Weeks; 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, activated partial thromboplastin time and fibrinogen.; timeFrame: Up to 68 Weeks

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.

How to read this history