NCT06420297
OLE Study of Carbetocin Nasal Spray for the Treatment of Hyperphagia in Prader-Willi Syndrome
Enrolling by Invitation
PHASE3Ages 5–30InterventionalTreatmentACADIA Pharmaceuticals Inc.
~160 participants
Updated 2025-12-03 on ClinicalTrials.gov
What's tested:Carbetocin
At a glance
Recruiting sites
0 of 30 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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
Measured over Baseline to 36 months
Conditions
Where it's being run
30 sites across 21 statesCalifornia3
Spain3
United Kingdom3
Missouri2
Texas2
Germany2
Alabama1
Arizona1
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Has completed the Week12/EOT visit of the antecedent, Study ACP-101-302
Met all entry criteria for the antecedent study
May benefit from long-term treatment with open-label carbetocin in the judgment of the Investigator.
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.
Exclusion
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
Has a clinically significant abnormality in vital signs at Baseline
Has an average QTcF interval of \>450 ms on the Baseline ECG performed before the first dose of carbetocin is given in the present study (i.e., the ECG performed at the EOT visit of the antecedent study)
Has developed a clinically significant ECG finding during the antecedent study
Subject is judged by the Investigator or the Medical Monitor to be inappropriate for the study due to AEs, medical condition, or noncompliance with investigational product or study procedures in the antecedent study
What this trial measures
- 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 malfunctionsBaseline to 36 months
Treatment-emergent adverse events (TEAEs) and device incidents or device malfunctions, TEAEs leading to discontinuation, TEAEs related to study drug, TEAEs by maximum severity, fatal TEAEs, treatment-emergent SAEs, and treatment-emergent SAEs related to study drug will all be summarized for all subjects as well as by previous treatment group.