Trial · NCT05933057
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change of Performance of Upper Limb 2.0 (PUL) total score at 18 months of treatment of givinostat compared to placebo group. | Baseline and 18 months | The PUL examines 3 major "dimensions" of upper extremity function: shoulder, middle, and distal functions. It includes 22 scored items; a score of 42 (12 for shoulder; 17 for mid-level, and 13 for distal) indicates the highest level of independent function and 0 the lowest. |
| Secondary | Change from baseline of Peak Expiratory Flow percent predicted (PEF%p) at 18 months of treatment of givinostat compared to placebo group | Baseline and 18 months | |
| Secondary | Change from baseline of Forced Vital Capacity percent predicted (FVC%p) at 18 months of treatment of givinostat compared to placebo group | Baseline and 18 months | |
| Secondary | Cumulative loss of PUL total score over 18 months of treatment of givinostat compared to placebo group. | Baseline to 18 months | |
| Secondary | Type, incidence, and severity of treatment-emergent adverse events | Baseline to 18 months | |
| Secondary | Proportion of patients experiencing treatment-emergent adverse events | Baseline to 18 months | |
| Secondary | Change from baseline vital signs and clinical laboratory tests | Baseline and 18 months | |
| Secondary | Change from baseline electrocardiogram and echocardiogram | Baseline and 18 months | |
| Secondary | Time to assisted ventilation and rate of respiratory infection including duration, severity of respiratory infection and use of antibiotics, of givinostat compared to placebo group. | Baseline to 18 months | |
| Other | Change from baseline of Fat Fraction of Deltoid and Biceps brachii using Dixon technique at 18 months of treatment of givinostat compared to placebo group | Baseline and 18 months | |
| Other | Proportion of responders of givinostat compared to placebo group | Baseline to 18 months | Responders are defined as patients who did not change their baseline PUL entry score at the EOS |
| Other | Change from baseline of shoulder, elbow and distal level domains of PUL at 18 months of treatment of givinostat compared to placebo group | Baseline and 18 months | |
| Other | Change from baseline in muscle strength (eg, elbow flexion) evaluated by hand held myometry at 18 months of treatment of givinostat compared to placebo group | Baseline and 18 months | |
| Other | Change from baseline in grip strength of dominant hand as measured by Jamar Smart Hand dynamometer at 18 months of treatment of givinostat compared to placebo group | Baseline and 18 months | |
| Other | Change from baseline in physical function as measured by Egen Klassifikation (EK) score at 18 months of treatment of givinostat compared to placebo group | Baseline and 18 months | |
| Other | Change from baseline as measured by Motor Function Measure (MFM) at 18 months of treatment of givinostat compared to placebo group | Baseline and 18 months | |
| Other | Change from baseline of Peak Cough Flow (PCF) at 18 months of treatment of givinostat compared to placebo group | Baseline and 18 months | |
| Other | Age at loss of hand-to-mouth function assessed by PUL | Baseline to 18 months | |
| Other | Age at loss of turn in bed ability assessed by EK | Baseline to 18 months | |
| Other | Change from baseline in DMD Upper Limb Patient-Reported Outcome Measures questionnaire scores at 18 months of treatment of givinostat compared to placebo group | Baseline and 18 months |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT05933057/registered