Extension Study of Pimavanserin in Adult Subjects With Neuropsychiatric Symptoms Related to Neurodegenerative Disease

Completed · Phase 3

Conditions studied: Neuropsychiatric Symptoms Related to Neurodegenerative Disease

In brief

The purpose of this study is to evaluate the long-term safety and tolerability of pimavanserin in adult and elderly subjects with neuropsychiatric symptoms related to neurodegenerative disease exposed to open-label pimavanserin for up to 52 weeks.

Key facts

Study ID: NCT03623321
Run by: ACADIA Pharmaceuticals Inc.
People needed: 595
Starts: 2018-07-17
Expected to finish: 2023-05-05
Last updated by the study team: 2024-12-20

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subject satisfied all entry criteria for the antecedent pimavanserin study
Subject completed the antecedent study; or was participating in a pimavanserin study that the Sponsor ended early
Has a designated study partner/caregiver who meets the following requirements:
In the Investigator's opinion, is in contact with the subject frequently enough to accurately report on the subject's symptoms and whether or not the subject is taking the study drug
In the Investigator's opinion, is considered reliable in providing support to the subject to help ensure compliance with study treatment, study visits, and protocol procedures
Is fluent in the local language in which study assessments will be administered
Agrees to participate in study assessments, has the capacity to provide informed consent, and provides written consent to participate in the study
Subject is willing and able to provide informed consent.
If the subject is female, she must not be pregnant or breastfeeding. She must also be of non-childbearing potential (defined as either surgically sterilized or at least 1 year postmenopausal) or must agree to use a clinically acceptable method of contraception or be abstinent during the study and 1 month following completion of the study.

You may not qualify if…

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, or is judged to be a danger to self or others
Is in hospice, is receiving end-of-life palliative care, or has become bedridden
Has any of the following ECG results at the EOT/ET visit of the antecedent study:
a. If the subject is not on citalopram, escitalopram, or venlafaxine:
i. QTcF >450 ms, if QRS duration <120 ms
ii. QTcF >470 ms, if QRS duration ≥120 ms
b. If the subject is on citalopram, escitalopram, or venlafaxine:
i. QTcF >425 ms, if QRS duration <120 ms
ii. QTcF >450 ms, if QRS duration ≥120 ms
Has a heart rate <50 beats per minute. If bradycardia is secondary to iatrogenic or treatable causes and these causes are treated, a heart rate assessment can be repeated at the EOT/ET visit of the antecedent study.
Has clinically significant laboratory abnormalities in the antecedent study that, in the judgment of the Investigator or Medical Monitor, would either:
jeopardize the safe participation of the subject in the study; OR
would interfere with the conduct or interpretation of safety or efficacy evaluations in the study
Is suicidal at Visit 1 (Baseline)
Has developed a medical condition that in the judgment of the Investigator, would increase the risk associated with taking study medication or significantly interfere with the conduct or interpretation of the study
Requires treatment with a medication or other substance that is prohibited by the protocol
Has a significant sensitivity or allergic reaction to pimavanserin or its excipients
Is an employee of ACADIA, or has a family member who is an employee of ACADIA
Additional inclusion/exclusion criteria apply. Patients will be evaluated at screening to ensure that all criteria for study participation are met. Patients may be excluded from the study based on these assessments (and specifically, if it is determined that their baseline health and psychiatric condition do not meet all pre-specified entry criteria).

Where it is running

ATP Clinical Research, Inc. — Costa Mesa, California, United States
Syrentis Clinical Research — Santa Ana, California, United States
Indago Research & Health Center Inc — Hialeah, Florida, United States
Reliable Clinical Research, LLC — Hialeah, Florida, United States
Premier Clinical Research Institute, Inc. — Miami, Florida, United States
Global Medical Institutes — Miami, Florida, United States
Future Care Solution, LLC — Miami, Florida, United States
MediClear Medical & Research Center, Inc. — Miami, Florida, United States
Novel Clinical Research LLC — Miami, Florida, United States
Laszlo J Mate, MD, PA — North Palm Beach, Florida, United States
Synexus Clinical Research US, Inc. — The Villages, Florida, United States
The NeuroCognitive Institute — Mount Arlington, New Jersey, United States
UNC Hospital — Chapel Hill, North Carolina, United States
Insight Clinical Trials LLC — Shaker Heights, Ohio, United States
Suburban Research Associates — Media, Pennsylvania, United States
Central for Biomedical Research, LLC — Knoxville, Tennessee, United States
Centre for Mental Health Prof. Dr. Ivan Temkov, Lazur Compl., Park Ezero — Burgas, Bulgaria
UMHAT Psych clin for gen psychiatry and addictions — Pleven, Bulgaria
DCC Sv. Vrach and Sv. Sv. Kozma and Damyan — Sofia, Bulgaria
Diagnostic Consultative Centre, 2, N. Vaptzarov Street — Varna, Bulgaria
Diagnostic Consultative Centre-Mladost-Psychiatry, 15, Republika Blvd. — Varna, Bulgaria
Mental Health Center Vratza EOOD, 1 Belasitsa St. — Vratsa, Bulgaria
E.S.E. Hospital Mental de Antioquia — Bello, Antioquia, Colombia
Centr Investigaciones y Proyectos en Neurociencias — Barranquilla, Atlántico, Colombia
Cognitive Clinical Trials — Gilbert, Arizona, United States

Full record on ClinicalTrials.gov

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