Open-Label Study With Pimavanserin on Activities of Daily Living in Subjects With Parkinson's Disease Psychosis

  • STATUS
    Recruiting
  • participants needed
    53
  • sponsor
    ACADIA Pharmaceuticals Inc.
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Updated on 19 February 2024
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Summary

To assess the effect of pimavanserin on the activities of daily living in subjects with Parkinson's Disease Psychosis

Description

This study will be conducted as a 16-week, multi-center, single-arm, open-label study. Pimavanserin will be administered at a dose of 34 mg to approximately 50 subjects with PDP

Details
Condition Parkinson Disease Psychosis
Age 40years - 100years
Treatment Pimavanserin
Clinical Study IdentifierNCT04292223
SponsorACADIA Pharmaceuticals Inc.
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

b'Male or female subjects at least 40 years of age'
b'Has a Mini-Mental State Examination (MMSE) score \\u226521 at Screening'
b'Does not meet the criteria for all-cause dementia'
b"Has a diagnosis of idiopathic Parkinson's disease (PD)"
b'Has psychotic symptoms severe enough to warrant treatment with an antipsychotic agent'
b'Psychotic symptoms developed after the diagnosis of PD was established'
b'If the subject is female, she must not be pregnant or breastfeeding. She must also be'
b'of non-childbearing potential (defined as either surgically sterilized or at least 1'
b'year postmenopausal) OR must agree to use TWO clinically acceptable methods of'
b'contraception.'

Exclusion Criteria

b"Has atypical parkinsonism (Parkinson's plus, multiple system atrophy [MSA],"
b'progressive supranuclear palsy [PSP]), or secondary parkinsonism variants such as'
b'tardive or medication induced parkinsonism'
b'Has current evidence of an unstable neurological, cardiovascular, respiratory,'
b'gastrointestinal, renal, hepatic, hematologic, or other medical or psychiatric'
b'disorder, including cancer or malignancies that, in the judgment of the Investigator,'
b'would jeopardize the safe participation of the subject in the study or significantly'
b'interfere with the conduct or interpretation of the study'
b'Has a history of myocardial infarction, unstable angina, acute coronary syndrome, or'
b'cerebrovascular accident within the last 6 months prior to Screening'
b'Has any of the following:'
b'greater than New York Heart Association (NYHA) Class 2 congestive heart failure'
b'Grade 2 or greater angina pectoris (by Canadian Cardiovascular Society Angina'
b'Grading Scale)'
b'sustained ventricular tachycardia'
b'ventricular fibrillation'
b'torsades de pointes'
b'syncope due to an arrhythmia'
b'an implantable cardiac defibrillator'
b'Has a known personal or family history of long QT syndrome or family history of sudden'
b'cardiac death'
b'Requires treatment with a medication or other substance that is prohibited by the'
b'protocol'
b'Has a body mass index (BMI) <18.5 kg/m2 or >35 kg/m2 at Screening or Baseline or known'
b'unintentional clinically significant weight loss (i.e., \\u22657%) over past 6 months'
b'Is suicidal at Screening or Baseline'
b'Has a history of a significant psychotic disorder prior to or concomitantly with the'
b'onset of PD including, but not limited to, schizophrenia or bipolar disorder'
b'Had dementia prior to or concomitantly with the onset of motor symptoms of PD'
b'Is judged by the Investigator or the Medical Monitor to be inappropriate for the study'
b'for any reason'
b'Additional inclusion/exclusion criteria apply. Subjects will be evaluated at screening to'
b'ensure that all criteria for study participation are met.'
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