Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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:
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.
Exclusion criteria
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:
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).
Primary purpose
Allocation
Interventional model
Masking
595 participants in 1 patient group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal