A Multi-Center, Placebo-Controlled, Double-Blind Trial To Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson's Disease
- Conditions
- Psychosis in Parkinson's DiseaseMedDRA version: 9.1Level: LLTClassification code 10037241Term: Psychosis NOS
- Registration Number
- EUCTR2007-002906-23-FR
- Lead Sponsor
- Acadia Pharmaceuticals Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 280
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. Presence of visual and/or auditory hallucinations, and/or delusions, occuring during the four weeks prior to the screening visit.
4. Symptoms severe enough to warrant treatment with an antipsychotic agent as documented by items A and B of the NPI and defined as Hallucinations (Frequency X Severity) and Delusions (Frequency X Severity) = a total score of 4.
5. Psychotic symptoms must be present for > 1 month and have developed after PD diagnosis was established.
6. Subject must be on stable dose of anti-Parkinson's medication for 1 month prior to Study Day 1 (baseline) and during the trial.
7. 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.
8. Subject must have clear sensorium at study entry (i.e. oriented to time, person, and place) and thus not be delirious.
9. The subject is willing and able to provide consent.
10. Caregiver is willing and able 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
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 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.
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 450 msec or a QRS duration > 120 msec or PR interval > 210 msec.
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method