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

This study has been completed.
Sponsor:
Information provided by:
ACADIA Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT00087542
First received: July 9, 2004
Last updated: December 5, 2005
Last verified: December 2005
  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 Intervention Phase
Hallucinations
Psychoses
Parkinson's Disease
Drug: ACP-103
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by ACADIA Pharmaceuticals Inc.:

Primary Outcome Measures:
  • ACP-103 is an effective treatment for Parkinson's Disease with psychosis

Secondary Outcome Measures:
  • ACP-103 does not cause worsening of motor function in Parkinson's Disease

Estimated Enrollment: 60
Study Start Date: March 2004
Estimated Study Completion Date: December 2005
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 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
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00087542

Locations
United States, California
Fountain Valley, California, United States, 92708
Sunnyvale, California, United States, 94089
United States, Connecticut
Danbury, Connecticut, United States, 06810
United States, Florida
Pompano Beach, Florida, United States, 33060
Tampa, Florida, United States, 33606
United States, Georgia
Atlanta, Georgia, United States, 30329
United States, Kansas
Kansas City, Kansas, United States, 66160
United States, Maryland
Elkridge, Maryland, United States, 21075
United States, New York
Albany, New York, United States, 12205
United States, North Carolina
Asheville, North Carolina, United States, 28806
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19107
United States, Rhode Island
Pawtucket, Rhode Island, United States, 02860
United States, Tennessee
Brentwood, Tennessee, United States, 37027
Sponsors and Collaborators
ACADIA Pharmaceuticals Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00087542     History of Changes
Other Study ID Numbers: ACP-103-006
Study First Received: July 9, 2004
Last Updated: December 5, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by ACADIA Pharmaceuticals Inc.:
Hallucinosis/Psychosis

Additional relevant MeSH terms:
Hallucinations
Parkinson Disease
Mental Disorders
Psychotic Disorders
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on July 20, 2014