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Growth Hormone Study in Adults With Prader-Willi Syndrome

Study acronym: GAP
StatusUnknown
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated February 16, 2023 (before its estimated September 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Changed Registry marked status Unknown (sponsor has not verified the record since Feb 2023); last known: Not Yet Recruiting
  2. Phase: Phase 3 to Not specified Enrollment target: 50 to 25 · Primary completion date: Jan 1, 2024 to Sep 1, 2026 · Start date: Oct 1, 2020 to Mar 24, 2023 · 9 morev2 Show 12 more changesShow less
    • Enrollment target: 50 to 25
    • Primary completion date: Jan 1, 2024 to Sep 1, 2026
    • Start date: Oct 1, 2020 to Mar 24, 2023
    • Study sites: 2 to 1
    • Completion date: Jan 1, 2024 to Oct 1, 2026
    • Interventions: Placebo (Drug), Somatropin (Drug) to not stated
    • Eligibility criteria shortened, about 59 words
    • Secondary endpoints: 7 to 6
    • Study description shortened, about 62 words
    • Collaborators: 3 to 2
    • Study arms: 2 to 1
    • Study title shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The overall objective of this study is to measure the effect of growth hormone (GH) treatment on physical and psychosocial health in adults with Prader-Willi syndrome. Adults with PWS who have not been treated with GH during the past three years and who will start with GH treatment as part of regular patient care will be asked for informed consent to participate in this open-label prospective cohort study. We hypothesize that growth hormone treatment will improve the physical and psychosocial health.
Trial Details
NCT Number NCT04484051
Lead Sponsor Erasmus Medical Center
Collaborators: Foundation for Prader-Willi Research, Prader-Willi Fonds
Conditions Prader-Willi Syndrome
Enrollment 25 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov