Treatment of Hallucinosis/Psychosis in Parkinson's Disease by an Investigational Drug
1 other identifier
interventional
60
1 country
13
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2004
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2004
CompletedFirst Submitted
Initial submission to the registry
July 9, 2004
CompletedFirst Posted
Study publicly available on registry
July 14, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2005
CompletedDecember 7, 2005
December 1, 2005
July 9, 2004
December 5, 2005
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ACP-103 is an effective treatment for Parkinson's Disease with psychosis
Secondary Outcomes (1)
ACP-103 does not cause worsening of motor function in Parkinson's Disease
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Unknown Facility
Fountain Valley, California, 92708, United States
Unknown Facility
Sunnyvale, California, 94089, United States
Unknown Facility
Danbury, Connecticut, 06810, United States
Unknown Facility
Pompano Beach, Florida, 33060, United States
Unknown Facility
Tampa, Florida, 33606, United States
Unknown Facility
Atlanta, Georgia, 30329, United States
Unknown Facility
Kansas City, Kansas, 66160, United States
Unknown Facility
Elkridge, Maryland, 21075, United States
Unknown Facility
Albany, New York, 12205, United States
Unknown Facility
Asheville, North Carolina, 28806, United States
Unknown Facility
Philadelphia, Pennsylvania, 19107, United States
Unknown Facility
Pawtucket, Rhode Island, 02860, United States
Unknown Facility
Brentwood, Tennessee, 37027, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 9, 2004
First Posted
July 14, 2004
Study Start
March 1, 2004
Study Completion
December 1, 2005
Last Updated
December 7, 2005
Record last verified: 2005-12