OLE Study of Carbetocin Nasal Spray for the Treatment of Hyperphagia in Prader-Willi Syndrome
Launched by ACADIA PHARMACEUTICALS INC. · May 14, 2024
Trial Information
Current as of February 14, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
This is a long-term, OLE study to evaluate long-term safety and tolerability of carbetocin nasal spray (3.2 mg TID) in subjects with PWS. Subjects who complete the antecedent double-blind study (ACP-101-302) will be invited to participate in the present study.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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 Criteria:
- • 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
- • Additional inclusion/exclusion criteria apply. Subjects will be evaluated at screening to ensure that all criteria for study participation are met.
About Acadia Pharmaceuticals Inc.
Acadia Pharmaceuticals Inc. is a biopharmaceutical company dedicated to the development and commercialization of innovative therapies for central nervous system (CNS) disorders. With a strong focus on advancing treatments for conditions such as Parkinson's disease psychosis, schizophrenia, and other neurodegenerative diseases, Acadia leverages cutting-edge science and clinical expertise to address unmet medical needs. The company's commitment to rigorous research and patient-centric approaches aims to improve the quality of life for individuals affected by complex neurological conditions, positioning Acadia as a leader in the CNS therapeutic area.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Brooklyn, New York, United States
Iowa City, Iowa, United States
Phoenix, Arizona, United States
Aurora, Colorado, United States
Columbus, Ohio, United States
Palo Alto, California, United States
San Diego, California, United States
Kansas City, Missouri, United States
Montreal, Quebec, Canada
Birmingham, Alabama, United States
Edmonton, Alberta, Canada
Nashville, Tennessee, United States
Palo Alto, California, United States
San Antonio, Texas, United States
Fort Worth, Texas, United States
Saint Louis, Missouri, United States
Chicago, Illinois, United States
Glasgow, , United Kingdom
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0