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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03482882
• Date of registration: 23/03/2018
• Prospective Registration: No
• Primary sponsor: ACADIA Pharmaceuticals Inc.
• Public title: Safety and Efficacy of Pimavanserin in Adults With Parkinson's Disease and Depression
• Scientific title: An Open-label, 8-Week Study of Safety and Efficacy of Pimavanserin Treatment in Adults With Parkinson's Disease and Depression
• Date of first enrolment: March 9, 2018
• Target sample size: 47
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03482882
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United States

Key inclusion & exclusion 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.



Age minimum: 50 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

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

Intervention(s)

Drug: Pimavanserin

Primary Outcome(s)

Change From Baseline to Week 8 in HAMD-17 (Hamilton Depression Scale -17 Items) Total Score [Time Frame: From baseline to Week 8]

Secondary Outcome(s)

Change From Baseline (CFB) in Clinical Global Impression-Severity (CGI-S) [Time Frame: From baseline to Week 8]

Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) [Time Frame: From baseline to Week 8]

Change From Baseline (CFB) in SCOPA Daytime Sleepiness (DS) Score [Time Frame: From baseline to Week 8]

Change From Baseline (CFB) in HAMD-17 Total Score at Weeks 2, 4, and 6 [Time Frame: 2, 4, and 6 weeks from baseline]

Change From Baseline (CFB) in Scale of Outcomes in PD-Sleep Scale (SCOPA) Nighttime Sleep (NS)Score [Time Frame: From baseline to Week 8]

Clinical Global Impression-Improvement (CGI-I) [Time Frame: At Week 8]

The Number (or Percentage) of Responders [Time Frame: From baseline to Week 8]

Secondary ID(s)

ACP-103-048

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 31/08/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03482882