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

Primary Purpose

Treatment of Depression in Adults With Parkinson's Disease (PD)

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pimavanserin
Sponsored by
ACADIA Pharmaceuticals Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Treatment of Depression in Adults With Parkinson's Disease (PD)

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • ATP Clinical Research, Inc.
  • The Parkinson's and Movement Disorder Institute
  • SC3 Research-Reseda
  • The Neurology Group
  • SC3 Research-Reseda
  • CNS Network
  • Associated Neurologists, P.C.
  • Parkinson's Disease and Movement Disorder Center of Boca Raton
  • University of Florida
  • Parkinson's Disease Treatment Center of SW Florida
  • Infinity Clinical Research, LLC
  • Tallahassee Neurological Clinic, P.A.
  • SRI Biosciences, Clinical Trials and Strategic Development Services
  • Washington University School of medicine
  • Bio Behavioral Health
  • Albany Medical College
  • David L. Kreitzman, MD, PC
  • Asheville Neurology Specialists, PA
  • Neurology/Neurophysiology
  • Booth Gardner Parkinson's Care Center
  • Inland Northwest Research

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Drug - pimavanserin

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline to Week 8 in HAMD-17 (Hamilton Depression Scale -17 Items) Total Score
The HAMD-17 is a multiple-item questionnaire to assess the severity of depression, including items of mood, feelings of guilt, suicide ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms. Each of the 17 items is scored on a 3- or 5-point scale (depending on the item). The minimum total score is 0; the maximum total score is 52. A higher total score signifies more severe depression.

Secondary Outcome Measures

Change From Baseline (CFB) in HAMD-17 Total Score at Weeks 2, 4, and 6
The HAMD-17 is a multiple-item questionnaire to assess the severity of depression, including items of mood, feelings of guilt, suicide ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms. Each of the 17 items is scored on a 3- or 5-point scale (depending on the item). The minimum total score is 0; the maximum total score is 52. A higher total score signifies more severe depression.
Clinical Global Impression-Improvement (CGI-I)
The CGI-I is a clinician-rated 7-point scale to rate the improvement in the patient's depression at the time of assessment relative baseline. The CGI-I ranges from 1 (very much improved) to 7 (very much worse)
Change From Baseline (CFB) in Clinical Global Impression-Severity (CGI-S)
The CGI-S is a clinician-rated 7-point scale to rate the severity of the patient's depression at the time of assessment. The CGI-S ranges from 1 (normal) to 7 (patient is among the most severely ill).
Change From Baseline (CFB) in Scale of Outcomes in PD-Sleep Scale (SCOPA) Nighttime Sleep (NS)Score
The SCOPA-NS subscale addresses problems in nighttime sleep and consists of 5 items (sleep initiation, sleep fragmentation, sleep efficiency, sleep duration, early wakening). Each item has 4 response options (ranging from 0=not at all to 3=a lot). The SCOPA-NS score ranges from 0 to 15, with a higher score indicating more severe nighttime sleep problems.
Change From Baseline (CFB) in SCOPA Daytime Sleepiness (DS) Score
The SCOPA-DS subscale addresses problems in daytime sleepiness and consists of 6 items (falling asleep unexpectedly, falling asleep peacefully, falling asleep watching TV/reading, falling asleep while talking to someone, having difficulty staying awake, whether falling asleep in the daytime is considered a Problem). Each item has 4 response options (from 0=never to 3=often). The SCOPA-DS subscale score ranges from 0 to 18, with a higher score indicating more severe DS problems.
The Number (or Percentage) of Responders
The HAMD-17 is a multiple-item questionnaire to assess the severity of depression, including items of mood, feelings of guilt, suicide ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms. Each of the 17 items is scored on a 3- or 5-point scale (depending on the item). The minimum total score is 0; the maximum total score is 52. A higher total score signifies more severe Depression. Response was defined as ≥50% reduction from baseline in HAMD-17 total score. Patients without Week-8 score were counted as nonresponders.
Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)
The EQ-5D-5L is a standardized measure of health status. The questionnaire consists of 2 components: the EQ-5D-5L descriptive system and the EQ-5D-5L Visual Analogue scale (EQ-5D-5L VAS). The descriptive system consists of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels (from 1=no problem to 5=extreme Problems). The digits for the 5 dimensions are combined into a 5-digit code that describes the patient's health state, which is then converted into a single summary index value. Health state index scores generally range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility. The EQ-5D-5L VAS records the patient's health on a vertical visual analogue scale, ranging from 100 (=the best health you can imagine) to 0 (=the worst health you can imagine).

Full Information

First Posted
March 23, 2018
Last Updated
August 14, 2020
Sponsor
ACADIA Pharmaceuticals Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03482882
Brief Title
Safety and Efficacy of Pimavanserin in Adults With Parkinson's Disease and Depression
Official Title
An Open-label, 8-Week Study of Safety and Efficacy of Pimavanserin Treatment in Adults With Parkinson's Disease and Depression
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
March 9, 2018 (Actual)
Primary Completion Date
July 9, 2019 (Actual)
Study Completion Date
July 24, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ACADIA Pharmaceuticals Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment of Depression in Adults With Parkinson's Disease (PD)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Drug - pimavanserin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Pimavanserin
Intervention Description
Pimavanserin 34 mg total daily dose, tablets, once daily by mouth (provided as two 17 mg NUPLAZID® tablets)
Primary Outcome Measure Information:
Title
Change From Baseline to Week 8 in HAMD-17 (Hamilton Depression Scale -17 Items) Total Score
Description
The HAMD-17 is a multiple-item questionnaire to assess the severity of depression, including items of mood, feelings of guilt, suicide ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms. Each of the 17 items is scored on a 3- or 5-point scale (depending on the item). The minimum total score is 0; the maximum total score is 52. A higher total score signifies more severe depression.
Time Frame
From baseline to Week 8
Secondary Outcome Measure Information:
Title
Change From Baseline (CFB) in HAMD-17 Total Score at Weeks 2, 4, and 6
Description
The HAMD-17 is a multiple-item questionnaire to assess the severity of depression, including items of mood, feelings of guilt, suicide ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms. Each of the 17 items is scored on a 3- or 5-point scale (depending on the item). The minimum total score is 0; the maximum total score is 52. A higher total score signifies more severe depression.
Time Frame
2, 4, and 6 weeks from baseline
Title
Clinical Global Impression-Improvement (CGI-I)
Description
The CGI-I is a clinician-rated 7-point scale to rate the improvement in the patient's depression at the time of assessment relative baseline. The CGI-I ranges from 1 (very much improved) to 7 (very much worse)
Time Frame
At Week 8
Title
Change From Baseline (CFB) in Clinical Global Impression-Severity (CGI-S)
Description
The CGI-S is a clinician-rated 7-point scale to rate the severity of the patient's depression at the time of assessment. The CGI-S ranges from 1 (normal) to 7 (patient is among the most severely ill).
Time Frame
From baseline to Week 8
Title
Change From Baseline (CFB) in Scale of Outcomes in PD-Sleep Scale (SCOPA) Nighttime Sleep (NS)Score
Description
The SCOPA-NS subscale addresses problems in nighttime sleep and consists of 5 items (sleep initiation, sleep fragmentation, sleep efficiency, sleep duration, early wakening). Each item has 4 response options (ranging from 0=not at all to 3=a lot). The SCOPA-NS score ranges from 0 to 15, with a higher score indicating more severe nighttime sleep problems.
Time Frame
From baseline to Week 8
Title
Change From Baseline (CFB) in SCOPA Daytime Sleepiness (DS) Score
Description
The SCOPA-DS subscale addresses problems in daytime sleepiness and consists of 6 items (falling asleep unexpectedly, falling asleep peacefully, falling asleep watching TV/reading, falling asleep while talking to someone, having difficulty staying awake, whether falling asleep in the daytime is considered a Problem). Each item has 4 response options (from 0=never to 3=often). The SCOPA-DS subscale score ranges from 0 to 18, with a higher score indicating more severe DS problems.
Time Frame
From baseline to Week 8
Title
The Number (or Percentage) of Responders
Description
The HAMD-17 is a multiple-item questionnaire to assess the severity of depression, including items of mood, feelings of guilt, suicide ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms. Each of the 17 items is scored on a 3- or 5-point scale (depending on the item). The minimum total score is 0; the maximum total score is 52. A higher total score signifies more severe Depression. Response was defined as ≥50% reduction from baseline in HAMD-17 total score. Patients without Week-8 score were counted as nonresponders.
Time Frame
From baseline to Week 8
Title
Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)
Description
The EQ-5D-5L is a standardized measure of health status. The questionnaire consists of 2 components: the EQ-5D-5L descriptive system and the EQ-5D-5L Visual Analogue scale (EQ-5D-5L VAS). The descriptive system consists of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels (from 1=no problem to 5=extreme Problems). The digits for the 5 dimensions are combined into a 5-digit code that describes the patient's health state, which is then converted into a single summary index value. Health state index scores generally range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility. The EQ-5D-5L VAS records the patient's health on a vertical visual analogue scale, ranging from 100 (=the best health you can imagine) to 0 (=the worst health you can imagine).
Time Frame
From baseline to Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Can understand and provide signed informed consent, request for medical records and/or subject privacy form if applicable according to local regulations 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: rest tremor rigidity bradykinesia and/or akinesia postural and gait abnormalities Meets clinical criteria for depression with Parkinson's disease as listed in the NINDS/NIMH Guidelines 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. Is on a stable dose of anti-Parkinson's medication for 1 month prior to Screening If the subject is female, she must be of non-childbearing potential or agree to use two methods of clinically acceptable contraception Exclusion Criteria: Use of an antipsychotic within 3 weeks or 5 half-lives of Baseline (whichever is longer) Had a myocardial infarction within the 6 months prior to Screening Has a known personal or family history or symptoms of long QT syndrome Evidence of severe or medically significant hepatic or renal impairment on laboratory tests as assessed by the Investigator or Medical Monitor Has a history of PD psychosis, schizophrenia, or other psychotic disorder, or bipolar I or II disorder. Actively suicidal at Visit 1 (Screening) or Visit 2 (Baseline) Is pregnant or breastfeeding Has previously been treated with pimavanserin or is currently taking pimavanserin Has a sensitivity to pimavanserin or its excipients 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.
Facility Information:
Facility Name
ATP Clinical Research, Inc.
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
The Parkinson's and Movement Disorder Institute
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
SC3 Research-Reseda
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
The Neurology Group
City
Pomona
State/Province
California
ZIP/Postal Code
91767
Country
United States
Facility Name
SC3 Research-Reseda
City
Reseda
State/Province
California
ZIP/Postal Code
91335
Country
United States
Facility Name
CNS Network
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Associated Neurologists, P.C.
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Parkinson's Disease and Movement Disorder Center of Boca Raton
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Parkinson's Disease Treatment Center of SW Florida
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33980
Country
United States
Facility Name
Infinity Clinical Research, LLC
City
Sunrise
State/Province
Florida
ZIP/Postal Code
33351
Country
United States
Facility Name
Tallahassee Neurological Clinic, P.A.
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
SRI Biosciences, Clinical Trials and Strategic Development Services
City
Plymouth
State/Province
Michigan
ZIP/Postal Code
48170
Country
United States
Facility Name
Washington University School of medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Bio Behavioral Health
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Albany Medical College
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
David L. Kreitzman, MD, PC
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Asheville Neurology Specialists, PA
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28806
Country
United States
Facility Name
Neurology/Neurophysiology
City
Johnstown
State/Province
Pennsylvania
ZIP/Postal Code
15904
Country
United States
Facility Name
Booth Gardner Parkinson's Care Center
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States
Facility Name
Inland Northwest Research
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32804101
Citation
DeKarske D, Alva G, Aldred JL, Coate B, Cantillon M, Jacobi L, Nunez R, Norton JC, Abler V. An Open-Label, 8-Week Study of Safety and Efficacy of Pimavanserin Treatment in Adults with Parkinson's Disease and Depression. J Parkinsons Dis. 2020;10(4):1751-1761. doi: 10.3233/JPD-202058.
Results Reference
derived

Learn more about this trial

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

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