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Trial record 1 of 1 for:    NCT04292223
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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
Sponsor:
Information provided by (Responsible Party):
ACADIA Pharmaceuticals Inc.

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

Condition or disease Intervention/treatment Phase
Parkinson Disease Psychosis Drug: Pimavanserin Phase 4

Detailed 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 53 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Drug - Pimavanserin
Pimavanserin 34 mg administered orally
Drug: Pimavanserin
Pimavanserin 34 mg (provided as 1×34 mg capsule), administered orally, once daily for 16 weeks
Other Name: NUPLAZID




Primary Outcome Measures :
  1. 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
    • Social/Role function

      • 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)


Secondary Outcome Measures :
  1. 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"

  2. 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.

  3. 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.

  4. 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.

  5. 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.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female subjects at least 40 years of age
  2. Has a Mini-Mental State Examination (MMSE) score ≥21 at Screening
  3. Does not meet the criteria for all-cause dementia
  4. Has a diagnosis of idiopathic Parkinson's disease (PD)
  5. Has psychotic symptoms severe enough to warrant treatment with an antipsychotic agent
  6. Psychotic symptoms developed after the diagnosis of PD was established
  7. 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.

Exclusion Criteria:

  1. 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
  2. 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
  3. Has a history of myocardial infarction, unstable angina, acute coronary syndrome, or cerebrovascular accident within the last 6 months prior to Screening
  4. Has any of the following:

    1. greater than New York Heart Association (NYHA) Class 2 congestive heart failure
    2. Grade 2 or greater angina pectoris (by Canadian Cardiovascular Society Angina Grading Scale)
    3. sustained ventricular tachycardia
    4. ventricular fibrillation
    5. torsades de pointes
    6. syncope due to an arrhythmia
    7. an implantable cardiac defibrillator
  5. Has a known personal or family history of long QT syndrome or family history of sudden cardiac death
  6. Requires treatment with a medication or other substance that is prohibited by the protocol
  7. Has a body mass index (BMI) <18.5 kg/m2 or >35 kg/m2 at Screening or Baseline or known unintentional clinically significant weight loss (i.e., ≥7%) over past 6 months
  8. Is suicidal at Screening or Baseline
  9. Has a history of a significant psychotic disorder prior to or concomitantly with the onset of PD including, but not limited to, schizophrenia or bipolar disorder
  10. Had dementia prior to or concomitantly with the onset of motor symptoms of PD
  11. Is judged by the Investigator or the Medical Monitor to be inappropriate for the study for any reason

Additional inclusion/exclusion criteria apply. Subjects will be evaluated at screening to ensure that all criteria for study participation are met.


Information from the National Library of Medicine

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


Contacts
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Contact: Cheryl J. Knipe 609-250-6932 CKnipe@ACADIA-pharm.com
Contact: Lori Jacobi 609-250-6901 LJacobi@ACADIA-pharm.com

Locations
Show Show 26 study locations
Sponsors and Collaborators
ACADIA Pharmaceuticals Inc.
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Responsible Party: ACADIA Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT04292223    
Other Study ID Numbers: ACP-103-063
First Posted: March 3, 2020    Key Record Dates
Last Update Posted: November 23, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Psychotic Disorders
Mental Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Schizophrenia Spectrum and Other Psychotic Disorders
Pimavanserin
Antiparkinson Agents
Anti-Dyskinesia Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action