Open-Label Study With Pimavanserin on Activities of Daily Living in Subjects With Parkinson's Disease Psychosis
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|ClinicalTrials.gov Identifier: NCT04292223|
Recruitment Status : Recruiting
First Posted : March 3, 2020
Last Update Posted : November 23, 2020
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease Psychosis||Drug: Pimavanserin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||53 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A 16-Week Open-Label Study of the Effects of Treatment With Pimavanserin on Activities of Daily Living in Subjects With Parkinson's Disease Psychosis|
|Actual Study Start Date :||February 10, 2020|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||January 2021|
Experimental: Drug - Pimavanserin
Pimavanserin 34 mg administered orally
Pimavanserin 34 mg (provided as 1×34 mg capsule), administered orally, once daily for 16 weeks
Other Name: NUPLAZID
- Change from baseline (Week 0) to Week 16 on the modified Functional Status Questionnaire (mFSQ) total score [ Time Frame: 16 weeks ]
The mFSQ is a self-administered questionnaire that provides assessment in ambulatory patients of physical, psychological, social, and role function. It comprises 34 core items that produces 6 summary scale scores:
- Basic activities of daily living
- Intermediate activities of daily living
- Psychological function and mental health
- Work performance
- Social activity
- Quality interaction It also includes 6 single-item scores (work situation; days per month in bed due to illness or injury; days per month when illness injury reduced activities normally performed for half a day; satisfaction with sexual relationship; satisfaction with own health; frequency of social interaction)
- Change from baseline to Week 16 on the Schwab and England ADL Scale (Caregiver and Patient Version) [ Time Frame: 16 Weeks ]The Schwab & England ADL Scale is widely used in PD. It is rated by physicians, patients, or staff using a 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"
- Change from baseline to Week 16 on the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I and II (Caregiver and Patient Version) [ Time Frame: 16 Weeks ]The MDS-UPDRS is a comprehensive battery of motor and behavioral indices derived from the Columbia Scale (Fahn et al. 1987). The MDS-UPDRS Parts I and II will be used to assess mentation, behavior and mood (Part 1) and activities of daily living (Part II) and are rater-based examinations consisting of 4 and 13 items, respectively.
- Week 16 Clinical Global Impression - Improvement (CGI-I) score for hallucinations and delusions [ Time Frame: 16 Weeks ]The CGI-I is a clinician-rated, 7-point scale that is designed to rate the improvement in the subject's symptoms at the time of assessment, relative to the symptoms at Baseline (Guy 1976). Severity ratings should be based on the behavioral domains of clinical concern, namely hallucinations and delusions.
- Change from Baseline to Week 16 on the Clinical Global Impression - Severity of Illness (CGI-S) score for hallucinations and delusions [ Time Frame: 16 Weeks ]The CGI-S scale is a clinician-rated, 7-point scale that is designed to rate the severity of the subject's neuropsychiatric symptoms at the time of assessment using the Investigator's judgment and past experience with subjects who have the same disorder (Guy 1976). Severity ratings should be based on the behavioral domains of clinical concern, namely hallucinations and delusions.
- Week 16 on the Patient Global Impression of Improvement (PGI-I) score for hallucinations and delusions [ Time Frame: 16 Weeks ]The PGI-I is a global index used to rate the response of a condition to a therapy. It is a simple, direct, easy to use scale that is intuitively understandable to subjects and clinicians. The PGI-I asks the patient to rate their symptoms now, as compared with how it was at Baseline before beginning treatment, ranging from 1=very much better to 7=very much worse. Severity ratings should be based on the behavioral domains of clinical concern, namely hallucinations and delusions.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04292223
|Contact: Cheryl J. Knipe||609-250-6932||CKnipe@ACADIA-pharm.com|
|Contact: Lori Jacobi||609-250-6901||LJacobi@ACADIA-pharm.com|