NCT04003974Phase 2Completed

Efficacy and Safety of Losmapimod in Subjects With Facioscapulohumeral Muscular Dystrophy (FSHD)

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 completion2021-01-28Actual

Enrollment · participants80Actual

Source updated2024-07-10Last 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

Losmapimod oral tabletDrug
Placebo oral tabletDrugAlso known as Placebo

Primary outcomes · main study measures

Read the study measures

measure: Change From Baseline in Double Homeobox 4 (DUX4) Activity in Affected Skeletal Muscle; description: Skeletal muscle biopsies were collected at Baseline and post-Baseline. DUX4 activity in skeletal muscle biopsies was assessed by measuring expression levels of a panel of 6 genes known to be regulated by DUX4. Expression levels of genes were measured using a validated quantitative RT-PCR assay and expressed as Ct (PCR cycles). Raw Ct for each of the 6 genes was normalized to the specified reference genes to generate a normalized Ct. The DUX4 activity is the average of the normalized Cts of each of the identified 6 genes, where the Ct for each of the 6 genes is first normalized to reference genes before the average is generated. Change in Baseline is calculated as \[average delta Ct across the 6 genes post-baseline\] minus \[average delta Ct across the 6 genes at baseline\].; timeFrame: Baseline and Week 16 to Week 36

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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