Treatment of Hallucinosis/Psychosis in Parkinson's Disease by an Investigational Drug

Completed · Phase 2

Conditions studied: Hallucinations, Psychoses, Parkinson's Disease

In brief

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 secondary objectives are to determine whether ACP-103 will ameliorate psychosis in patients with Parkinson's disease and whether ACP-103 is safe in Parkinson's disease patients taking multiple anti-parkinsonian medications.

Key facts

Study ID

NCT00087542

Run by

ACADIA Pharmaceuticals Inc.

People needed

60

Starts

2004-03-01

Expected to finish

2005-12-01

Last updated by the study team

2005-12-07

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Fountain Valley, California, United States
• Study site — Sunnyvale, California, United States
• Study site — Danbury, Connecticut, United States
• Study site — Pompano Beach, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Kansas City, Kansas, United States
• Study site — Elkridge, Maryland, United States
• Study site — Albany, New York, United States
• Study site — Asheville, North Carolina, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Pawtucket, Rhode Island, United States
• Study site — Brentwood, Tennessee, United States

Full record on ClinicalTrials.gov

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