Psychosis in Parkinson's Disease MedDRA version: 9.1 Level: LLT Classification code 10037241 Term: Psychosis NOS
Conditions
Interventions
Product Name: Pimavanserin tartrate
Product Code: ACP-103
Pharmaceutical Form: Tablet
INN or Proposed INN: Pimavanserin tartrate
CAS Number: 706782-28-7
Concentration unit: mg milligram(s)
Pharmaceuti
Sponsors
Acadia Pharmaceuticals Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female of 40 years of age or older with 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 2. 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 IUD, diaphragm, or oral, injectable or implantable contraception, for at least one month prior to randomization, during the study, and one month following completion of the study 3. Subjects must have psychotic symptoms that developed after the diagnosis of Parkinson’s Disease was established. These symptoms must include visual hallucinations and/or auditory hallucinations, and/or delusions 4. Psychotic symptoms must have been present for at least one month and the subject must have actively experienced psychotic symptoms during the month prior to the Screening visit 5. Symptoms severe enough to warrant treatment with an antipsychotic agent as documented by items A and B of the NPI, and defined as the sum of Hallucinations (Frequency × Severity) and Delusions (Frequency × Severity) = a total score of 4 6. At the baseline visit, subject must have a SAPS total score of greater than or equal to 5 based on the sum of the Hallucinations and Delusions subscales. 7. Subject must be on stable dose of anti-Parkinson's medication for 1 month prior to Study Day 1 (baseline) and during the trial 8. Subject that has received stereotaxic surgery for subthalamic nucleus deep brain stimulation must be at least 6 months post surgery and the stimulator settings must have been stable for at least 1 month prior to Study Day 1 (Baseline) and must remain stable during the trial 9. Subject must have clear sensorium at study entry (i.e. oriented to time, person, and place) and thus not be delirious 10. The subject is willing and able to provide consent 11. Caregiver is willing and able to accompany the subject 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: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subject with psychotic symptoms (hallucinations and delusions) which could be better explained as a part of a toxic, metabolic or infection-induced delirium/encephalopathy, psychosis due to substance abuse, psychosis associated with schizophrenia, bipolar disorder or psychotic depression 2. Subject has a history of significant psychotic disorders prior to or concomitantly with the diagnosis of Parkinson's desease including, but not limited to, schizophrenia or bipolar disorder 3. Subject has atypical parkinsonism (Parkinson's plus, MSA, PSP), or secondary parkinsonism variants such as tardive or medication induced parkinsonism 4. Subject has received previous ablative stereotaxic surgery (i.e. pallidotomy and thalamotomy) to treat Parkinson's disease 5. Subject had dementia prior to or concomitantly with the diagnosis of Parkinson's disease (PD) that may be inconsistent with a PD diagnosis 6. A score on the Mini-Mental State Examination (MMSE) of < 21 7. Subject has history of cerebrovascular ischemic syndrome (stroke) that impairs their ability to complete the MMSE 8. Subject has visual impairment including visual acuity problems (e.g. cataracts) that may impair assessments or better explain visual hallucinations 9. Subject is using or has used any of the medications prohibited or restricted as described in Appendix 1 (Prohibited and Restricted Concomitant Medications) 10. Subject has current evidence of a serious and or unstable cardiovascular, respiratory, gastrointestinal, renal, hematologic or other medical disorder, including cancer or malignancies, which would affect the subject’s ability to participate in the study 11. Subject has had a myocardial infarction in last six months 12. Subject has moderate to severe congestive heart failure (NYHA class III or IV) 13. Subject has known history or symptoms of long QT syndrome 14. Subject is on medications known to prolong the QT interval (as described in Appendix 1) 15. Subject has a screening and baseline electrocardiogram (ECG) with Bazett’s corrected QT (QTcB) of greater than 460 msec if male or 470 msec if female 16. Subject has clinically significant laboratory abnormalities that in the judgement of the investigator would jeopardize the safe conduct of the study 17. Subject is pregnant or breastfeeding. Female subjects of child-bearing potential must have a negative serum pregnancy test at screening, and it must be confirmed at Study Day 1 (Baseline) using a dipstick urine pregnancy test 18. Subject has any surgery planned during the screening, treatment or follow-up periods 19. Subject is likely to have an allergy or sensitivity to ACP-103 based on known allergies to drugs of the same class 20. Subject has previously participated in any prior clinical study with ACP-103, and/or received of any other investigational drug within 30 days prior to the screening visit 21. Subject is judged by the Investigator to be inappropriate for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the antipsychotic efficacy of ACP-103 in subjects with PDP as measured by a decrease in the severity and/or frequency of hallucinations and/or delusions;Secondary Objective: - To demonstrate that ACP-103 does not worsen motor symptoms of PD in PDP subjects - To evaluate the effect of ACP-103 on global severity of and improvement in psychosis in subjects with PDP - To demonstrate the safety and tolerability of ACP-103;Primary end point(s): Primary end point is the combined score for the Hallucinations and Delusions domains of the Scale for the Assessment of Positive Symptoms (SAPS). The primary endpoint will be the difference in the mean absolute change in the combined SAPS Hallucinations and Delusions scores between an active arm and the placebo arm from Study Day 1 (Baseline) to Study Day 42 The primary objective of this study will be to demonstrate the antipsychotic efficacy of ACP-103 in subjects with PDP as measured by a decrease in the severity and/or frequency of hallucinations and delusions, the core symptoms of PDP | — |
Countries
Bulgaria, France, United Kingdom
Outcome results
None listed