Trials
Search / Trial NCT06420297

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

Opel Label Extension Safety Tolerability

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.

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