CompletedPhase 4

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

United States29 participantsStarted 2020-02-10

Plain-language summary

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

Age range40 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Male or female subjects at least 40 years of age
✓. Has a Mini-Mental State Examination (MMSE) score ≥19 at Screening
✓. Has a diagnosis of idiopathic Parkinson's disease (PD)
✓. Has psychotic symptoms that may impair function and are severe enough to warrant treatment with an antipsychotic agent
✓. Psychotic symptoms developed after the onset of symptoms of PD
✓. 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 TWO clinically acceptable methods of contraception.

✕. Has atypical parkinsonism (Parkinson's plus, multiple system atrophy \[MSA\], progressive supranuclear palsy \[PSP\]), or secondary parkinsonism variants such as tardive or medication induced parkinsonism
✕. Has undergone ablative procedures such as a pallidotomy, thalamotomy, or treatment with focused ultrasound, or has an implanted deep brain stimulator
✕. Has current evidence of an unstable neurological, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical or psychiatric disorder, including cancer or malignancies that, in the judgment of the Investigator, would jeopardize the safe participation of the subject in the study or significantly interfere with the conduct or interpretation of the study
✕. Has a history of myocardial infarction, unstable angina, acute coronary syndrome, or cerebrovascular accident within the last 6 months prior to Screening
✕. Has any of the following:
✕. greater than New York Heart Association (NYHA) Class 2 congestive heart failure
✕. Grade 2 or greater angina pectoris (by Canadian Cardiovascular Society Angina Grading Scale)
✕. sustained ventricular tachycardia

Change From Baseline to Week 16 in Modified Functional Status Questionnaire (mFSQ) Total Score

Timeframe: 16 weeks

NCT IDNCT04292223

SponsorACADIA Pharmaceuticals Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-04-26

Results submitted2023-06-12

Who can participate

Age range40 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Male or female subjects at least 40 years of age
✓. Has a Mini-Mental State Examination (MMSE) score ≥19 at Screening
✓. Has a diagnosis of idiopathic Parkinson's disease (PD)
✓. Has psychotic symptoms that may impair function and are severe enough to warrant treatment with an antipsychotic agent
✓. Psychotic symptoms developed after the onset of symptoms of PD
✓. 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 TWO clinically acceptable methods of contraception.

✕. Has atypical parkinsonism (Parkinson's plus, multiple system atrophy \[MSA\], progressive supranuclear palsy \[PSP\]), or secondary parkinsonism variants such as tardive or medication induced parkinsonism
✕. Has undergone ablative procedures such as a pallidotomy, thalamotomy, or treatment with focused ultrasound, or has an implanted deep brain stimulator
✕. Has current evidence of an unstable neurological, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical or psychiatric disorder, including cancer or malignancies that, in the judgment of the Investigator, would jeopardize the safe participation of the subject in the study or significantly interfere with the conduct or interpretation of the study
✕. Has a history of myocardial infarction, unstable angina, acute coronary syndrome, or cerebrovascular accident within the last 6 months prior to Screening
✕. Has any of the following:
✕. greater than New York Heart Association (NYHA) Class 2 congestive heart failure
✕. Grade 2 or greater angina pectoris (by Canadian Cardiovascular Society Angina Grading Scale)
✕. sustained ventricular tachycardia