NCT03616509 is a Phase 4 clinical trial of Growth hormone in Prader-Willi Syndrome, sponsored by Corporacion Parc Tauli.

Who is sponsoring NCT03616509?

NCT03616509 is sponsored by Corporacion Parc Tauli.

What drugs are being tested in NCT03616509?

Interventions in NCT03616509: Growth hormone, Placebo.

What condition does NCT03616509 study?

NCT03616509 studies Prader-Willi Syndrome.

Is NCT03616509 still recruiting?

NCT03616509 is currently completed. Last updated 27 January 2021.

Last reviewed 2021-01-27 · How we verify

NCT03616509

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 4 Last updated 27 January 2021

What this trial tests

Phase 4 trial testing Growth hormone in Prader-Willi Syndrome in 30 participants. Completed in 26 July 2019.

Timeline

19 June 2017

Primary endpoint
26 July 2019

26 July 2019

Quick facts

Lead sponsor	Corporacion Parc Tauli
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	19 June 2017
Primary completion	26 July 2019
Estimated completion	26 July 2019
Sites	1 location across Spain

Drugs / interventions tested

Growth hormone — full drug profile →
Placebo

Conditions studied

Prader-Willi Syndrome — all drugs for Prader-Willi Syndrome →

Sponsor

Corporacion Parc Tauli — full company profile →

Who can join

18 and older, any sex, with Prader-Willi Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Prader-Willi syndrome (PWS) is a genetic disorder associated with growth hormone (GH) deficiency, central hypotonia and hyperphagia that leads to life-threatening obesity. Treatment with GH in adult patients is not well stablished in guidelines of Health National System (HNS). The investigators has experience in the study of brain connectivity in these patients in relation to satiety. To date, there is no evidence about the effect of GH on central hypotonia (brain areas related with muscle tone maintenance). So, the main objective is to examine these anatomical areas before and one year after GH treatment. Methodology: Structural and functional magnetic resonance imaging to 30 PWS patients before and after GH treatment and we will compare them to a control group. Expected results: PWS group will show abnormal functional and structural connectivity in circuitry of muscle tone maintenance that will improve after GH treatment. These favorable changes and the absence of secondary effects will help to justify the use of this treatment and its inclusion in practical clinical guidelines of HNS for the management of this syndrome in the adulthood.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Growth hormone

Trials testing the same drug.

NCT05585177 — Growth Hormone to Improve the Clinical Outcome of Assisted Fertility in Young Patients With Decreased Ovarian Reserve · NA · unknown
NCT05574894 — Effect of GH Supplementation on the Blastocyst Euploid Rate in AMA Patients--A Retrospective Cohort Study · Phase 3 · completed
NCT03966339 — Growth Hormone Adding to Controlled Ovarian Hyperstimulation for Improving Embryo Quality · NA · unknown
NCT03225755 — Adipose Tissue and Circulating Markers of Inflammation in GH Deficiency and Changes With GH Therapy · completed
NCT02217345 — Growth Hormone and Intrahepatic Lipid Content in Patients With Nonalcoholic Fatty Liver Disease · Phase 2 · completed

Other recruiting trials for Prader-Willi Syndrome

Currently open trials in the same condition.

NCT06877715 — Autistic Symptomatology and Sensory Profile in Children With Prader-Willi Syndrome · recruiting
NCT06772597 — A Study of Setmelanotide in Patients With Prader-Willi Syndrome · Phase 2 · active not recruiting
NCT06573723 — Institutional Registry of Rare Diseases · recruiting
NCT06239116 — A Study of RM-718 in Healthy Subjects and Patients With MC4R Pathway Impairment · Phase 1, PHASE2 · recruiting
NCT06144645 — A Clinical Evaluation of Non-Invasive Vagus Nerve Stimulation for Temper Outbursts in People With PWS · Phase 3 · active not recruiting

Other Corporacion Parc Tauli trials

Trials by the same sponsor.

NCT07331805 — Conservative Management in Primary Spontaneous Pneumothorax: a Multicenter Randomized Non-inferiority Study · NA · not yet recruiting
NCT06873360 — Medical Device for Oxaliplatin-Induced Neuropathy in Gastrointestinal Cancer Patients · completed
NCT06900335 — Functional Connectome in Prader-Willi Syndrome: Neuroimaging and AI to Assess Therapeutic Impact · completed
NCT06511700 — Implementation of the Intravitreal Injection Administered by Nurses · enrolling by invitation
NCT07298720 — Assessing Fluid-responsiveness Using Non-invasive Hybrid Diffuse Optics on Peripheral Muscle · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03616509 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Corporacion Parc Tauli
Last refreshed: 27 January 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03616509.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing