Status:
COMPLETED
Treatment of Hallucinosis/Psychosis in Parkinson's Disease by an Investigational Drug
Lead Sponsor:
ACADIA Pharmaceuticals Inc.
Conditions:
Hallucinations
Psychoses
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
The primary objective is to demonstrate that the investigational new drug, ACP-103, is well tolerated by, and will not worsen parkinsonism in, patients with Parkinson's disease and psychosis. The seco...
Detailed Description
This is a Phase 2, multi-center, randomized, placebo-controlled, double-blind trial of four weeks of ACP-103 treatment of psychosis in Parkinson's disease, with four weeks follow-up. A total of 60 pa...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Male and female patients of any ethnic group and of any age are eligible for participation in this study, providing they meet all the following criteria:
- Subjects with a clinical diagnosis of idiopathic Parkinson's disease, defined as the presence of at least three of the cardinal features of the disease including: rest tremor, rigidity, bradykinesia and/or akinesia, postural balance abnormalities, in the absence of alternative explanations or atypical features.
- Psychosis, defined by the presence of visual and/or auditory hallucinations, with or without delusions, of at least four weeks duration.
- Psychosis, assessed 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 or greater.
- Stable anti-Parkinsonian medication(s) use for at least one week prior to study entry.
- A reliable caretaker who will accompany the subject to each visit, and who can reliably report on the subject's daily level of function.
- Exclusion Criteria
- Patients who meet any of the following conditions are excluded from the clinical study:
- Inability of subject or caretaker to provide informed consent.
- Pregnant or breastfeeding. Female subjects of child-bearing potential must have a negative urine pregnancy test at screening.
- Female subjects must be of non-childbearing potential or must comply with double-barrier protection methods against conception during the study and for at least one month prior to randomization and one month following completion of the study.
- Presence of any systemic factor contributing to the psychosis such as urinary infection, liver disease, renal failure, anemia, infection, etc. as defined by a comprehensive medical evaluation.
- History of a significant pre-morbid psychiatric condition before the diagnosis of Parkinson's disease, including major depression, mania, or psychotic depression.
- Dementia precluding accurate assessment on psychiatric assessment battery and defined as a score on the MMSE \< 21.
- Use of depot neuroleptic within the past year.
- Prior exposure to non-depot neuroleptics within the past 90 days, except for quetiapine or clozapine. Quetiapine and clozapine-treated patients may be enrolled if these agents were discontinued due to drug intolerability. Such patients must not have taken these drugs within the past two weeks.
- Use of the following drugs within the past two weeks: benztropine, biperiden, trihexylphenidyl, amitriptyline, clomipramine, desipramine, nortriptyline, imipramine, doxepin, fluvoxamine, mirtazepine, nefazodone and trazodone.
- Change of anti-depressant, anxiolytic, anticholinergic (specifically oxybutynin, tolterodine), or cognitive enhancer (specifically rivastigmine, tacrine, donepezil, galantamine) dose within the past 30 days and during the 28-day duration of the trial.
- Use of any investigational product within the past 30 days.
- Inability to tolerate a stable level of anti-parkinsonian medications for one week.
- Uncontrolled angina or history of a myocardial infarction within the past three months.
- Concurrent illness that would make use of ACP-103 potentially hazardous.
Exclusion
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2005
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00087542
Start Date
March 1 2004
End Date
December 1 2005
Last Update
December 7 2005
Active Locations (13)
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1
Fountain Valley, California, United States, 92708
2
Sunnyvale, California, United States, 94089
3
Danbury, Connecticut, United States, 06810
4
Pompano Beach, Florida, United States, 33060