GH in Adults With PWS, Effect on Hypotonia Evaluated by Functional MRI, Relationship With Strength and Body Composition

• Register: ClinicalTrials.gov
• Last refreshed on: 8 February 2021
• Main ID: NCT03616509
• Date of registration: 27/07/2018
• Prospective Registration: No
• Primary sponsor: Corporacion Parc Tauli
• Public title: GH in Adults With PWS, Effect on Hypotonia Evaluated by Functional MRI, Relationship With Strength and Body Composition
• Scientific title: Treatment With Growth Hormone in Adults With PWS, Effect on Muscular Tone Evaluated by Functional MRI, Relationship With Strength and Body Composition
• Date of first enrolment: June 19, 2017
• Target sample size: 30
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03616509
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Spain

Contacts

• Name: Olga Gimenez-Palop, MD, PhD
• Affiliation: Corporacio Sanitària Parc Taulí

Key inclusion & exclusion criteria

Inclusion Criteria:

- PWS >=18 years with growth hormone deficit

- Signed informed consent by the patients or their legal guardian

Exclusion Criteria:

- Severe obesity

- No controled diabetes mellitus

- No treated obstructive sleep apnea or severe obstructive sleep apnea

- Active cancer

- Active psychosis



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Prader-Willi Syndrome

Intervention(s)

Drug: Growth hormone

Drug: Placebo

Primary Outcome(s)

Examine brain connectivity areas related with muscle tone maintenance [Time Frame: 24 months]

Secondary Outcome(s)

Evaluation of body composition [Time Frame: 24 months]

Evaluation of strength [Time Frame: 24 months]

Secondary ID(s)

END-GH-2017

2017-002164-41

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Parc de Salut Mar