OLE Study of Carbetocin Nasal Spray for the Treatment of Hyperphagia in Prader-Willi Syndrome

Plain-language guide to NCT06420297: phase 3 interventional trial of Carbetocin, hyperparathyroidism, 168 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT06420297
Phase: phase 3
Status: terminated early
Start: 2024-03-11
Completion (planned or actual): 2025-12-19
Participants: 168 (actual)
Design: na, open label (everyone knows who gets what), treatment
Conditions studied: Hyperphagia in Prader-Willi Syndrome
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 3) is built around Carbetocin for hyperparathyroidism.

It had 1 arm (groups): Drug: Carbetocin (experimental).

The registry classes the interventions as drug.

More on the Plan

Subjects who complete the antecedent double-blind study (ACP-101-302) will be invited to participate in the present study.

Who Took Part

The registry lists 168 actual participants took part.

It was open to people of any sex aged from 5 years up to 30 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Has completed the Week12/EOT visit of the antecedent, Study ACP-101-302. Met all entry criteria for the antecedent study. Lives with a caregiver who understands and is willing and able to adhere to study-related procedures and is willing to participate in all study visits.

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: history of, or current, cerebrovascular disease, brain trauma, epilepsy, or frequent migraines. a history of febrile seizures is not exclusionary; active psychotic symptoms, a history of psychotic symptoms, or a psychotic disorder; history of suicide attempt or inpatient psychiatric hospitalization.

How the Study Was Run

The set-up was single-group and open-label.

Nothing was hidden in this open-label Carbetocin study: the hyperparathyroidism participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2024-03-11 with completion listed for 2025-12-19.

It ran at 30 sites in United States (19), Spain (3), United Kingdom (3), Canada (2), Germany (2) and France (1).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), withdrawals due to adverse events (AEs), potentially clinically important changes in other safety assessments, device incidents or device malfunctions (time frame: Baseline to 36 months).

What This Means in Plain Language

Put simply, this is a phase 3 trial of Carbetocin in 168 people with hyperparathyroidism.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Carbetocin compound page, Hyperparathyroidism research.

Our Notes on the Compound

Carbetocin: A long-acting oxytocin analog used outside the US to prevent bleeding after childbirth; also studied intranasally in Prader-Willi syndrome.

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.