Growth Hormone Study in Adults With Prader-Willi Syndroom
Latest Information Update: 20 Feb 2023
At a glance
- Drugs Somatropin (Primary)
- Indications Prader-Willi syndrome
- Focus Therapeutic Use
- Acronyms GAP
- 15 Feb 2023 The protocol has been amended to change the study design from randomized, cross-over, double-blind to observational, cohort. Timepoint for primary end-point has been increased from 27 to 36 months. The 2 treatment arms have been replaced by 1 cohort and planned enrollment decreased from 50 to 25. Minimum age limit has been decreased from 30 years to 18 years. Australia is removed from locations.
- 15 Feb 2023 Planned number of patients changed from 50 to 25.
- 15 Feb 2023 Planned End Date changed from 1 Jan 2024 to 1 Oct 2026.