Treatment of Hallucinosis/Psychosis in Parkinson's Disease by an Investigational Drug
This study is currently recruiting patients.
Sponsored by: |
ACADIA Pharmaceuticals Inc. |
Information provided by: |
ACADIA Pharmaceuticals Inc. |
Purpose
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.
Condition
|
Treatment or Intervention |
Phase |
Hallucinations Psychoses Parkinson's Disease
|
Drug: ACP-103
|
Phase II
|
MedlinePlus related topics: Mental Health; Neurologic Diseases; Parkinson's Disease
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study
Further Study Details:
Expected Total Enrollment:
60
Study start: March 2004
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 patients meeting entrance criteria will be randomly assigned to receive placebo (30 patients) or active drug
(30 patients). Subjects will take study drug daily starting on Day 1. Dose escalations can occur on Study Days 8 and 15 only,
and patients will receive a stable daily dosage from Day 16 until Day 28. Single step dose reductions are allowed during that
period for adverse events or intolerance.
Patients will be evaluated at screening/baseline and at Study Days 1, 8, 15, 28, and 57 by raters blinded to the treatment.
The major response variable will be motoric tolerability. Secondary response variables will be efficacy against psychosis
and safety.
Currently, there are no approved drugs for this indication in the United States. Psychotic symptoms in Parkinson's disease
patients are almost always stable, often non-threatening, and rarely paranoid or violent in content. The trial includes the
requirement that each patient enrolled has a reliable caretaker who will accompany the patient to each visit who can reliably
report on the patient's daily level of function. These factors argue for the safe inclusion of a four-week period of placebo
treatment.
Eligibility
Genders Eligible for Study:
Both
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 neuroloeptics 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, nortripytline, 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.
Location
and Contact
Information
California Sunnyvale,
California,
United States; Recruiting
Florida Tampa,
Florida,
United States; Recruiting
Georgia Atlanta,
Georgia,
United States; Recruiting
Maryland Baltimore,
Maryland,
United States; Recruiting
Elkridge,
Maryland,
United States; Recruiting
Massachusetts Boston,
Massachusetts,
United States; Recruiting
Missouri St. Louis,
Missouri,
United States; Recruiting
New York Schenectady,
New York,
United States; Recruiting
Pennsylvania Philadelphia,
Pennsylvania,
United States; Recruiting
Rhode Island Pawtucket,
Rhode Island,
United States; Recruiting
More Information
Study ID Numbers:
ACP-103-006
Record last reviewed:
October 2004
Record first received:
July 9, 2004
ClinicalTrials.gov Identifier:
NCT00087542Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10