Psychosis in Parkinson's Disease MedDRA version: 20.0 Level: LLT Classification code 10037241 Term: Psychosis NOS System Organ Class: 100000004873
Conditions
Interventions
Product Name: Pimavanserin tartrate
Product Code: pimavanserin (ACP-103)
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Pimavanserin tartr
Sponsors
ACADIA Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject has completed the blinded treatment period of a previous study of pimavanserin in PDP within the last 28 days and, who may, in the opinion of the Investigator, benefit from therapy with pimavanserin 2. Subject must have clear sensorium at study entry (i.e., oriented to time, person, and place) and thus not be delirious 3. Female subjects must be of non-childbearing potential (defined as either surgically sterilized or at least 1 year post-menopausal) or must agree to use a clinically acceptable method of contraception (such as intrauterine device [IUD], diaphragm, or oral, injectable [e.g. Depo-Provera] or implantable contraception [e.g. Norplant? System]) during the study and one month following completion of the study 4. The subject is willing and able to provide consent 5. Caregiver is willing and able to provide consent and agrees to accompany the subject to all visits Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 350
Exclusion criteria
Exclusion criteria: 1. Subject has current evidence of a clinically significant concurrent medical illness including: severe cardiac disease (recent myocardial infarction, congestive heart failure or cardiac syncope), severe pulmonary disease (chronic obstructive pulmonary disease or emphysema), renal insufficiency or failure, hepatitis, a recent diagnosis of malignancy (excluding basal or squamous cell carcinoma), a serious and or unstable gastrointestinal, hematologic or other medical disorder 2. Subject is using any of the medications prohibited or restricted as described in Appendix 1 (Prohibited and Restricted Concomitant Medications 3. Subject is on medications known to prolong the QT interval (as described in Appendix 1) 4. Subject has a baseline electrocardiogram (ECG) with Bazett’s corrected QT (QTcB) of greater than 460 msec if male or 470 msec if female 5. Subject had an allergy or sensitivity to pimavanserin based on known allergies to drugs of the same class 6. Subject is judged by the Investigator to be inappropriate for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Not applicable; Primary end point(s): Safety: • The safety of subjects will be assessed by monitoring adverse events, physical examinations, vital signs, clinical laboratory tests (hematology, clinical chemistry, and urinalysis) and ECGs. ; Timepoint(s) of evaluation of this end point: Baseline, Week 2, Month 1, Month 3, Month 6, Month 9, Month 12 and every 6 months thereafter ;Main Objective: To assess long-term safety and tolerability of pimavanserin in subjects with Parkinson’s Disease Psychosis (PDP) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not Applicable;Timepoint(s) of evaluation of this end point: Not Applicable | — |
Countries
Austria, Belgium, Canada, European Union, France, India, Italy, Portugal, Russian Federation, Sweden, Ukraine, United Kingdom, United States
Contacts
Public ContactLewis Gryziewicz
Acadia Pharmaceuticals Inc.
Outcome results
None listed