Who is sponsoring NCT05032326?

NCT05032326 is sponsored by University Hospital, Toulouse.

What drugs are being tested in NCT05032326?

Interventions in NCT05032326: Follow-up study of the treated cohort, Follow-up study of the untreated cohort.

What condition does NCT05032326 study?

NCT05032326 studies Prader-Willi Syndrome.

Is NCT05032326 still recruiting?

NCT05032326 is currently recruiting now. Last updated 30 April 2024.

Last reviewed 2024-04-30 · How we verify

NCT05032326: OTBB3-FU

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

Long-term Interventional Follow-up Study of Children With Prader-Willi Syndrome Included in the OTBB3 Clinical Trial

Recruiting now Phase 3 Last updated 30 April 2024

What this trial tests

Phase 3 trial testing Follow-up study of the treated cohort in Prader-Willi Syndrome in 80 participants. Currently enrolling.

Timeline

7 September 2021

Primary endpoint
1 April 2025

1 April 2025

Quick facts

Lead sponsor	University Hospital, Toulouse
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	80
Start date	7 September 2021
Primary completion	1 April 2025
Estimated completion	1 April 2025
Sites	12 locations across France

Drugs / interventions tested

Follow-up study of the treated cohort — full drug profile →
Follow-up study of the untreated cohort

Conditions studied

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

Sponsor

University Hospital, Toulouse

Who can join

Adults 12 Months to 36 Months, any sex, with Prader-Willi Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is a prospective, multicentre, interventional cohort study in children with Prader-Willi Syndrome (PWS) over 4 years (no treatment administered). The duration of the preceding OTTB3 study is 26 weeks. An untreated cohort of children with PWS will be included at an age of 2 years and followed up until an age of 4 years. Regarding the untreated cohort, children with PWS born in France and too old to be recruited in OTBB3 trial, principally those who were born within one year before the start of OTBB3 trial, will be offered to participate in this study. Infants born later who couldn't be included in OTBB3 study will be also offered to participate.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Oxytocin in infants with Prader-Willi syndrome to improve dysphagia and disease trajectory.
Tauber M, Diene G, Fichaux-Bourin P, Pinto G, et al · · 2026 · PMID 41639888 · DOI 10.1186/s13023-026-04214-8

Verify or expand the search:

Other trials of Follow-up study of the treated cohort

Trials testing the same drug.

NCT06676527 — Vorolanib in the Second-line Treatment of Patients With Unresectable or Metastatic Renal Cell Carcinoma · recruiting

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 University Hospital, Toulouse trials

Trials by the same sponsor.

NCT07497750 — Impact of Artificial Intelligence Algorithm-driven Versus Standard Lifestyle Intervention in Non-Alcoholic Fatty Liver D · NA · not yet recruiting
NCT07507240 — The Benefits of a Care Pathway Combining Remote Monitoring and Support From a Nurse After a Change in Anti-epileptic Tre · NA · not yet recruiting
NCT07524088 — Contamination of Young Children Hair During Acute Cannabis Intoxication · NA · not yet recruiting
NCT07470580 — Radiofrequency Ablation Versus Adrenalectomy for Adenoma in Patients With Primary Aldosteronism and Hypertension · NA · not yet recruiting
NCT07423988 — Evaluation of Changes in Sleep Efficiency Among PIC DU MIDI Staff Between Nights Spent at Home and Nights Spent in the W · NA · 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 NCT05032326 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University Hospital, Toulouse
Last refreshed: 30 April 2024

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/NCT05032326.

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