Clinical trial NCT03482882: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Treatment of Depression in Adults With Parkinson's Disease (PD)
Lead sponsor: ACADIA Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2018-03-29
Enrollment: 47
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Change From Baseline to Week 8 in HAMD-17 (Hamilton Depression Scale -17 Items) Total Score
timeFrame: From baseline to Week 8
Secondary outcomes:
measure: Change From Baseline (CFB) in HAMD-17 Total Score at Weeks 2, 4, and 6
timeFrame: 2, 4, and 6 weeks from baseline
measure: Clinical Global Impression-Improvement (CGI-I)
timeFrame: At Week 8
measure: Change From Baseline (CFB) in Clinical Global Impression-Severity (CGI-S)
timeFrame: From baseline to Week 8
measure: Change From Baseline (CFB) in Scale of Outcomes in PD-Sleep Scale (SCOPA) Nighttime Sleep (NS)Score
timeFrame: From baseline to Week 8
measure: Change From Baseline (CFB) in SCOPA Daytime Sleepiness (DS) Score
timeFrame: From baseline to Week 8
measure: The Number (or Percentage) of Responders
timeFrame: From baseline to Week 8
measure: Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)
timeFrame: From baseline to Week 8
Other outcomes:
Locations:
city: Costa Mesa
country: United States
facility: ATP Clinical Research, Inc.
state: California
city: Fountain Valley
country: United States
facility: The Parkinson's and Movement Disorder Institute
state: California
city: Pasadena
country: United States
facility: SC3 Research-Reseda
state: California
city: Pomona
country: United States
facility: The Neurology Group
state: California
city: Reseda
country: United States
facility: SC3 Research-Reseda
state: California
city: Torrance
country: United States
facility: CNS Network
state: California
city: Danbury
country: United States
facility: Associated Neurologists, P.C.
state: Connecticut
city: Boca Raton
country: United States
facility: Parkinson's Disease and Movement Disorder Center of Boca Raton
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Port Charlotte
country: United States
facility: Parkinson's Disease Treatment Center of SW Florida
state: Florida
city: Sunrise
country: United States
facility: Infinity Clinical Research, LLC
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Neurological Clinic, P.A.
state: Florida
city: Plymouth
country: United States
facility: SRI Biosciences, Clinical Trials and Strategic Development Services
state: Michigan
city: Saint Louis
country: United States
facility: Washington University School of medicine
state: Missouri
city: Toms River
country: United States
facility: Bio Behavioral Health
state: New Jersey
city: Albany
country: United States
facility: Albany Medical College
state: New York
city: Commack
country: United States
facility: David L. Kreitzman, MD, PC
state: New York
city: Asheville
country: United States
facility: Asheville Neurology Specialists, PA
state: North Carolina
city: Johnstown
country: United States
facility: Neurology/Neurophysiology
state: Pennsylvania
city: Kirkland
country: United States
facility: Booth Gardner Parkinson's Care Center
state: Washington
city: Spokane
country: United States
facility: Inland Northwest Research
state: Washington
Study officials:
References:
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.