Treatment of Hallucinosis/Psychosis in Parkinson's Disease by an Investigational Drug
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.
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 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.
Study Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment
Conditions
Hallucinations
Intervention
ACP-103
Location
Fountain Valley
California
United States
92708
Status
Completed
Source
ACADIA Pharmaceuticals Inc.
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00087542
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Depressive Disorder, Major
Marked depression appearing in the involution period and characterized by hallucinations, delusions, paranoia, and agitation.
Hallucinations
Subjectively experienced sensations in the absence of an appropriate stimulus, but which are regarded by the individual as real. They may be of organic origin or associated with MENTAL DISORDERS.
Psychotic Disorders
Disorders in which there is a loss of ego boundaries or a gross impairment in reality testing with delusions or prominent hallucinations. (From DSM-IV, 1994)
Schizophrenia
A severe emotional disorder of psychotic depth characteristically marked by a retreat from reality with delusion formation, HALLUCINATIONS, emotional disharmony, and regressive behavior.
Schizophrenia And Disorders With Psychotic Features
Marked disorders of thought (delusions, hallucinations, or other thought disorder accompanied by disordered affect or behavior), and deterioration from a previous level of functioning.
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