NL-OMON48505
Not yet recruiting
Phase 3
Randomized, controlled growth hormone study in children and adolescents with a Prader-Willi-like phenotype, followed by a two year open-label growth hormone study - effects on body composition, growth, psychosocial development and quality of life - Prader-Willi-like (PWL) study
Stichting Kind en Groei0 sites64 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Stichting Kind en Groei
- Enrollment
- 64
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Prader\-Willi\-like phenotype, according to the PWL criteria (see below), or
- •with a proven molecular diagnosis of a uniparental disomy of chromosome 14
- •(mUPD14\), or a mutation or duplication in the 15q11\.2\-q13 region (PWS\-critical
- •\- Absence of a molecular diagnosis of PWS. This includes a type 1 (from
- •breakpoint 1 to breakpoint 4\) or type 2 (from breakpoint 2 to breakpoint 4\)
- •deletion, a uniparental disomy or imprinting center defect of the 15q11\.2\-q13
- •o Boys: 4 to 16 years
- •o Girls: 4 to 14 years.
- •\- Written informed consent. , PWL criteria:
- •The PWL phenotype is present in case of the following symptoms:
Exclusion Criteria
- •\- Non\-cooperative behavior
- •\- Extremely low dietary intake of less than the minimally required intake
- •according to WHO
- •\- Use of medication to reduce weight
- •\- BMI \> \+4SD
- •\- Height velocity \<1 cm per year and/or closed epiphyseal growth plates, as
- •determined by an x\-ray of the hand
- •\- Pregnancy
Outcomes
Primary Outcomes
Not specified
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