Study with adult patients with Prader-Willi syndrome, which evaluate the effect of growth hormone therapy on muscle tone and its relation with muscle strength and body composition assessed with imaging procedures.

Growth hormone therapy in adults with Prader-Willi syndrome: Effect on muscle tone assessed by functional magnetic resonance imaging (fMRI) and its relation to muscle strenght and body composition.

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002164-41-ES

Enrollment

Unknown

Registered

2017-06-21

Start date

2017-07-03

Completion date

Unknown

Last updated

2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with Prader-Willi Syndrome (SPW) with Growth hormone deficit. MedDRA version: 20.0 Level: PT Classification code 10036476 Term: Prader-Willi syndrome System Organ Class: 10010331 - Congenital, familial and genetic disorders

Interventions

Trade Name: Genotonorm Miniquick 0,2 mg Pharmaceutical Form: Powder and solution for solution for injection INN or Proposed INN: RECOMBINANT HUMAN GROWTH HORMON Other descriptive name: RECOMBINANT HUM

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Patients with PWS = 18 years • Patients who have demonstrated a GH deficiency in at least one of the two GH stimuli tests performed in routine clinical practice • Patients (or their legal guardians if they are legally incapacitated) who have signed informed consent to participate in the study. In the case of patients legally incapacitated, they will give their assent in participating. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Contraindications for MRI • Inability to stand still during MRI • Impossibility to understand the paradigm to be realized during the MRI • Severe obesity, uncontrolled diabetes, severe untreated obstructive sleep apnea, active cancer and active psychosis • Patients who present any other contraindication to treatment with GH according to the data sheet. • Any circumstance that at the discretion of the physician may pose a risk or clinical harm to the patient's participation in the study or interfere with the assessments of the same.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the muscle tone with functional magnetic resonance imaging (fMRI) in adult patients undergoing SPW with hormone deficit, before and after 12 months of GH treatment.;Secondary Objective: 1. To assess the effect of GH treatment on the muscle strength before and after 12 months of treatment. 2. To assess the effect of GH treatment on the body composition before and after 12 months of treatment. 3. To study if there are changes on different cognitives aspects before and after 12 months of treatment. 4. To study if there are changes in some of the metabolism regulatory hormones (leptina and kisspeptina) and if they correlate with body composition changes. 5. To study the sleeping architecture, the presence of respiratory sleep disorder and the sleeping quality, before and after 12 months of GH treatment.;Primary end point(s): Muscle tone with functional magnetic resonance imaging (fMRI);Timepoint(s) of evaluation of this end point: 12 months	—

Measure

Time frame

Main Objective: To assess the muscle tone with functional magnetic resonance imaging (fMRI) in adult patients undergoing SPW with hormone deficit, before and after 12 months of GH treatment.;Secondary Objective: 1. To assess the effect of GH treatment on the muscle strength before and after 12 months of treatment. 2. To assess the effect of GH treatment on the body composition before and after 12 months of treatment. 3. To study if there are changes on different cognitives aspects before and after 12 months of treatment. 4. To study if there are changes in some of the metabolism regulatory hormones (leptina and kisspeptina) and if they correlate with body composition changes. 5. To study the sleeping architecture, the presence of respiratory sleep disorder and the sleeping quality, before and after 12 months of GH treatment.;Primary end point(s): Muscle tone with functional magnetic resonance imaging (fMRI);Timepoint(s) of evaluation of this end point: 12 months

—

Secondary

Measure	Time frame
Secondary end point(s): 1. Study of muscle strength 2. Study of body composition 3. Study of bone mineral density 4. Mental and cognitive assessment 5. Polysomnography 6. Hormonal study 7. Safety;Timepoint(s) of evaluation of this end point: 12 months	—

Countries

Spain

Contacts

Public ContactOficina de Recerca

Hospital Universitari Parc Taulí

afarre@tauli.cat34937458451

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026