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Trial record 1 of 1 for:    ACP-103-047
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Extension Study of Pimavanserin in Adult Subjects With Neuropsychiatric Symptoms Related to Neurodegenerative Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03623321
Recruitment Status : Recruiting
First Posted : August 9, 2018
Last Update Posted : December 9, 2019
Sponsor:
Information provided by (Responsible Party):
ACADIA Pharmaceuticals Inc.

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.

Condition or disease Intervention/treatment Phase
Neuropsychiatric Symptoms Related to Neurodegenerative Disease Drug: Pimavanserin Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 52-Week Open-label Extension Study of Pimavanserin in Adult and Elderly Subjects With Neuropsychiatric Symptoms Related to Neurodegenerative Disease
Actual Study Start Date : July 17, 2018
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. • Treatment-emergent adverse events (TEAEs) [ Time Frame: Treatment period and Follow-up period: 56 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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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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): NCT03623321


Contacts
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Contact: Jason Do 858-261-2971 Jdo@acadia-pharm.com
Contact: Brian Raether 858-768-6074 braether@acadia-pharm.com

Locations
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Sponsors and Collaborators
ACADIA Pharmaceuticals Inc.

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Responsible Party: ACADIA Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT03623321    
Other Study ID Numbers: ACP-103-047
2017-004439-36 ( EudraCT Number )
First Posted: August 9, 2018    Key Record Dates
Last Update Posted: December 9, 2019
Last Verified: December 2019
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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Neurodegenerative Diseases
Nervous System Diseases
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