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Safety and Efficacy of Pimavanserin in Adults With Parkinson's Disease and Depression

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03482882
Recruitment Status : Completed
First Posted : March 29, 2018
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
ACADIA Pharmaceuticals Inc.

Brief Summary:
The purpose of this study is to assess the efficacy of pimavanserin for the treatment of depression in adults with Parkinson's disease.

Condition or disease Intervention/treatment Phase
Treatment of Depression in Adults With Parkinson's Disease (PD) Drug: Pimavanserin Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, 8-Week Study of Safety and Efficacy of Pimavanserin Treatment in Adults With Parkinson's Disease and Depression
Actual Study Start Date : March 9, 2018
Actual Primary Completion Date : July 10, 2019
Actual Study Completion Date : July 24, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Drug - pimavanserin Drug: Pimavanserin
Pimavanserin 34 mg total daily dose, tablets, once daily by mouth (provided as two 17 mg NUPLAZID® tablets)




Primary Outcome Measures :
  1. Change from Baseline to Week 8 in the Hamilton Depression Scale -17 items (HAMD-17) total score [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Clinical Global Impression-Improvement (CGI-I) [ Time Frame: 8 weeks ]
  2. Change from Baseline in Clinical Global Impression-Severity (CGI-S) [ Time Frame: 8 weeks ]
  3. Change from Baseline in Scale of Outcomes in PD-Sleep Scale (SCOPA) night time sleep score [ Time Frame: 8 weeks ]
  4. Change from Baseline in SCOPA day time sleepiness score [ Time Frame: 8 weeks ]
  5. Proportion of responders (defined as ≥50% reduction from Baseline in HAMD-17 total score) [ Time Frame: 8 weeks ]
  6. Change from Baseline in EuroQol-5 dimensions-5 levels (EQ-5D-5L) [ Time Frame: 8 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:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Can understand and provide signed informed consent, request for medical records and/or subject privacy form if applicable according to local regulations
  2. Has a clinical diagnosis of idiopathic Parkinson's disease with a minimum duration of 1 year, defined as the presence of at least three of the following cardinal features, in the absence of alternative explanations or atypical features:

    1. rest tremor
    2. rigidity
    3. bradykinesia and/or akinesia
    4. postural and gait abnormalities
  3. Meets clinical criteria for depression with Parkinson's disease as listed in the NINDS/NIMH Guidelines
  4. If currently taking an anti-depressant, is being treated with only one SSRI or SNRI antidepressant at a dose within the US FDA-approved dose range. Subjects who are currently taking a second antidepressant or antidepressant augmentation agent at a sub-therapeutic dose or for an inadequate duration at Screening, and can be discontinued from this agent before the Baseline visit (in the opinion of the Investigator), may be eligible for the study.
  5. Is on a stable dose of anti-Parkinson's medication for 1 month prior to Screening
  6. If the subject is female, she must be of non-childbearing potential or agree to use two methods of clinically acceptable contraception

Exclusion Criteria:

  1. Use of an antipsychotic within 3 weeks or 5 half-lives of Baseline (whichever is longer)
  2. Had a myocardial infarction within the 6 months prior to Screening
  3. Has a known personal or family history or symptoms of long QT syndrome
  4. Evidence of severe or medically significant hepatic or renal impairment on laboratory tests as assessed by the Investigator or Medical Monitor
  5. Has a history of PD psychosis, schizophrenia, or other psychotic disorder, or bipolar I or II disorder.
  6. Actively suicidal at Visit 1 (Screening) or Visit 2 (Baseline)
  7. Is pregnant or breastfeeding
  8. Has previously been treated with pimavanserin or is currently taking pimavanserin
  9. Has a sensitivity to pimavanserin or its excipients
  10. Is judged by the Investigator or the Medical Monitor to be inappropriate for the study

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): NCT03482882


Locations
Show Show 21 study locations
Sponsors and Collaborators
ACADIA Pharmaceuticals Inc.
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Responsible Party: ACADIA Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT03482882    
Other Study ID Numbers: ACP-103-048
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 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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Pimavanserin
Parkinson Disease
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
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