To assess the effect of pimavanserin on the activities of daily living in subjects with Parkinson's Disease Psychosis
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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
29
Pimavanserin 34 mg (provided as 1×34 mg capsule), administered orally, once daily for 16 weeks
Movement Disorders Center of Arizona
Scottsdale, Arizona, United States
Neurology Center of North Orange County
Fullerton, California, United States
Change From Baseline to Week 16 in Modified Functional Status Questionnaire (mFSQ) Total Score
The mFSQ is a self-administered questionnaire. It comprises 34 core items that produce 6 summary scale scores (i.e. basic activities of daily living (ADL); intermediate ADL; psychological function and mental health; work performance, social activity, and quality of interaction) and 6 single-item scores (work situation; days/month in bed due to illness/injury; days/month when illness/injury reduced activities normally performed for half a day; satisfaction with sexual relationship; satisfaction with health; frequency of social interaction). The mFSQ is calculated as the unweighted mean of predefined subscale scores. The maximum mFSQ total score is 100, with higher scores indicating better functional status. The minimum score is 0 and the maximum score is 100.
Time frame: 16 weeks
Change From Baseline to Week 16 on the Schwab and England Activity of Daily Living (ADL) Scale, Caregiver and Patient Versions
The Schwab \& England ADL Scale is a scale ranging from 0% to 100% scale with 10% intervals, where 100% is "Completely independent. Unaware of difficulty" and 0% is "Vegetative functions such as swallowing, bladder and bowel functions are not functioning. Bedridden"
Time frame: 16 Weeks
Change From Baseline to Week 16 on the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I and II
The MDS-UPDRS is a battery of motor and behavioral indices. MDS-UPDRS Part I assesses non-motor aspects of experiences of daily living (EDL) and consists of 13 items (6 investigator assessed; 7 patient assessed, each scored on a 5-point Likert scale). The total score is the sum of the 13 individual items. The highest score is 52, higher scores mean more severe impact of the disease on non-motor aspects of ADL and the lowest score is 0. In Part 1, a lower score is better while a higher score is worse. Part II assesses motor aspects of EDL and consists of 13 items (all patient assessed, each on a 5-point Likert scale). The highest score is 52, higher scores mean more severe impact of the disease on motor aspects of ADL and the lowest score is 0. In Part 2, a lower score is better while a higher score is worse.
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Premier Clinical Research Institute, Inc.
Miami, Florida, United States
Global Health Research Center, Inc.
Miami Lakes, Florida, United States
Quantum Laboratories, Inc.
Pompano Beach, Florida, United States
Parkinson's Disease Treatment Center of Southwest Florida
Port Charlotte, Florida, United States
Accel Research Sites - Brain and Spine Institute
Port Orange, Florida, United States
Infinity Clinical Research, LLC
Sunrise, Florida, United States
Premiere Research Institute at Palm Beach Neurology
West Palm Beach, Florida, United States
AU Movement and Memory Disorders
Augusta, Georgia, United States
...and 8 more locations
Time frame: 16 Weeks
Week 16 Clinical Global Impression - Improvement (CGI-I) Score for Hallucinations and Delusions
The CGI-I is a clinician-rated, 7-point scale to rate the improvement in patient symptoms at the time of assessment, relative to the symptoms at baseline. Severity ratings are based on the behavioral domains of hallucinations and delusions. The score ranges from 1=very much improved to 7=very much worse. Higher scores denote more severe symptoms of hallucinations and delusions
Time frame: 16 Weeks
Change From Baseline to Week 16 on the Clinical Global Impression - Severity of Illness (CGI-S) Score for Hallucinations and Delusions
The CGI-S scale is a clinician-rated, 7-point scale to rate the severity of patient neuropsychiatric symptoms at the time of assessment using the Investigator's judgment and past experience with patients who have the same disorder. Severity ratings aree based on the behavioral domains of hallucinations and delusions.The score ranges from 1=normal, not at all ill to 7=among the most extremely ill patients. Higher scores denote more severe symptoms of hallucinations and delusions.
Time frame: 16 Weeks
Patient Global Impression of Improvement (PGI-I) Score for Hallucinations and Delusions at Week 16
The PGI-I is a global index to rate the response of a condition to a therapy. Patients have to rate their current symptoms, compared with baseline. Responses range from 1=very much better to 7=very much worse. Severity ratings are based on the behavioral domains of hallucinations and delusions.
Time frame: 16 Weeks