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Extension Study of Pimavanserin in Adult Subjects With Neuropsychiatric Symptoms Related to Neurodegenerative Disease

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ClinicalTrials.gov Identifier: NCT03623321
Recruitment Status : Recruiting
First Posted : August 9, 2018
Last Update Posted : September 17, 2021
Sponsor:
Information provided by (Responsible Party):
ACADIA Pharmaceuticals Inc.

Tracking Information
First Submitted Date  ICMJE August 7, 2018
First Posted Date  ICMJE August 9, 2018
Last Update Posted Date September 17, 2021
Actual Study Start Date  ICMJE July 17, 2018
Estimated Primary Completion Date August 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2018)
• Treatment-emergent adverse events (TEAEs) [ Time Frame: Treatment period and Follow-up period: 56 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Extension Study of Pimavanserin in Adult Subjects With Neuropsychiatric Symptoms Related to Neurodegenerative Disease
Official Title  ICMJE A 52-Week Open-label Extension Study of Pimavanserin in Adult and Elderly Subjects With Neuropsychiatric Symptoms Related to Neurodegenerative Disease
Brief Summary The purpose of this study is to evaluate the long-term safety and tolerability of pimavanserin in adult and elderly subjects with neuropsychiatric symptoms related to neurodegenerative disease exposed to open-label pimavanserin for up to 52 weeks.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neuropsychiatric Symptoms Related to Neurodegenerative Disease
Intervention  ICMJE Drug: Pimavanserin
• Pimavanserin 34 mg is provided as 2×17 mg tablets as single dose, once daily by mouth. Dose adjustments of pimavanserin down to 20 mg (provided as 2×10 mg tablets as a single dose, once daily by mouth) and up to 34 mg are permitted based on Investigator assessment of clinical response.
Study Arms  ICMJE Experimental: Drug - pimavanserin
Pimavanserin 34 mg is provided as 2×17 mg tablets as single dose, once daily by mouth. Dose adjustments of pimavanserin down to 20 mg (provided as 2×10 mg tablets as a single dose, once daily by mouth) and up to 34 mg are permitted based on Investigator assessment of clinical response.
Intervention: Drug: Pimavanserin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 18, 2019)
750
Original Estimated Enrollment  ICMJE
 (submitted: August 7, 2018)
300
Estimated Study Completion Date  ICMJE August 2023
Estimated Primary Completion Date August 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subject satisfied all entry criteria for the antecedent pimavanserin study
  2. Subject completed the antecedent study; or was participating in a pimavanserin study that the Sponsor ended early
  3. Has a designated study partner/caregiver who meets the following requirements:

    1. In the Investigator's opinion, is in contact with the subject frequently enough to accurately report on the subject's symptoms and whether or not the subject is taking the study drug
    2. In the Investigator's opinion, is considered reliable in providing support to the subject to help ensure compliance with study treatment, study visits, and protocol procedures
    3. Is fluent in the local language in which study assessments will be administered
    4. Agrees to participate in study assessments, has the capacity to provide informed consent, and provides written consent to participate in the study
  4. Subject is willing and able to provide informed consent.
  5. 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 a clinically acceptable method of contraception or be abstinent during the study and 1 month following completion of the study.

Exclusion Criteria:

  1. Subject is judged by the Investigator or the Medical Monitor to be inappropriate for the study, due to AEs, medical condition, or noncompliance with investigational product or study procedures in the antecedent study, or is judged to be a danger to self or others
  2. Is in hospice, is receiving end-of-life palliative care, or has become bedridden
  3. Has any of the following ECG results at the EOT/ET visit of the antecedent study:

    a. If the subject is not on citalopram, escitalopram, or venlafaxine:

    i. QTcF >450 ms, if QRS duration <120 ms

    ii. QTcF >470 ms, if QRS duration ≥120 ms

    b. If the subject is on citalopram, escitalopram, or venlafaxine:

    i. QTcF >425 ms, if QRS duration <120 ms

    ii. QTcF >450 ms, if QRS duration ≥120 ms

  4. Has a heart rate <50 beats per minute. If bradycardia is secondary to iatrogenic or treatable causes and these causes are treated, a heart rate assessment can be repeated at the EOT/ET visit of the antecedent study.
  5. Has clinically significant laboratory abnormalities in the antecedent study that, in the judgment of the Investigator or Medical Monitor, would either:

    1. jeopardize the safe participation of the subject in the study; OR
    2. would interfere with the conduct or interpretation of safety or efficacy evaluations in the study
  6. Is suicidal at Visit 1 (Baseline)
  7. Has developed a medical condition that in the judgment of the Investigator, would increase the risk associated with taking study medication or significantly interfere with the conduct or interpretation of the study
  8. Requires treatment with a medication or other substance that is prohibited by the protocol
  9. Has a significant sensitivity or allergic reaction to pimavanserin or its excipients
  10. Is an employee of ACADIA, or has a family member who is an employee of ACADIA

Additional inclusion/exclusion criteria apply. Patients will be evaluated at screening to ensure that all criteria for study participation are met. Patients may be excluded from the study based on these assessments (and specifically, if it is determined that their baseline health and psychiatric condition do not meet all pre-specified entry criteria).

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Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Brian Raether 858-768-6074 braether@acadia-pharm.com
Contact: Ana Berrio, MD 609-250-6948 aberrio@acadia-pharm.com
Listed Location Countries  ICMJE Bulgaria,   Colombia,   Czechia,   Georgia,   Mexico,   Poland,   Romania,   Russian Federation,   Serbia,   South Africa,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03623321
Other Study ID Numbers  ICMJE ACP-103-047
2017-004439-36 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party ACADIA Pharmaceuticals Inc.
Study Sponsor  ICMJE ACADIA Pharmaceuticals Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account ACADIA Pharmaceuticals Inc.
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP