Hipa.ai Research · Source: PubMed & ClinicalTrials.gov / AACT · Last updated:
The clinical evidence base for Givinostat comprises 4 peer-reviewed publications across 4 journals, 1 pivotal-trial primary-outcome rows reported to ClinicalTrials.gov, spanning indications including Muscular Dystrophy, Duchenne. Most recent publication: Long-Term Evaluation of Givinostat in Duchenne Muscular Dystrophy, and Natural History Comparisons., Ann Clin Transl Neurol, 2025.
Curated set of pivotal-trial result papers and recent publications in high-tier journals.
Per-arm reported values from Phase 2/3 and Phase 3 trials with results posted to ClinicalTrials.gov.
| Trial | Indication | Primary endpoint | Arm | Value |
|---|---|---|---|---|
| NCT02851797 | Muscular Dystrophy, Duchenne | Mean Change From Baseline in 4 Standard Stairs (4SC) Climb After 18 Months of Treatment Baseline and 18 months | Givinostat | 1.27 seconds (±0.040 Standard Error) |
| Placebo | 1.48 seconds (±0.058 Standard Error) |
2013–2025: 4 publications.
For individuals with Duchenne Muscular Dystrophy, the clinical evidence for Givinostat includes results from a pivotal trial. In NCT02851797, a study investigating Duchenne Muscular Dystrophy, the primary outcome measured was the mean change from baseline in the 4 Standard Stairs Climb (4SC) after 18 months of treatment. In the Givinostat arm of NCT02851797, the mean change from baseline in 4SC climb was 1.27 seconds (least squares mean) after 18 months of treatment. In the placebo arm of NCT02851797, the mean change from baseline in 4SC climb was 1.48 seconds (least squares mean) after 18 months of treatment.
All values are sourced from primary registry reporting; individual papers should be consulted for clinical decisions.
ctgov.study_references (PubMed PMIDs auto-attached by ClinicalTrials.gov to each trial), reference types RESULT, DERIVED, and BACKGROUND.ctgov.outcome_measurements joined to ctgov.design_outcomes where outcome_type = 'PRIMARY', restricted to phase PHASE3 and PHASE2/PHASE3.efetch.fcgi