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Expanded Access of Pimavanserin for Patients With PD Psychosis

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ClinicalTrials.gov Identifier: NCT02762591
Expanded Access Status : Approved for marketing
First Posted : May 5, 2016
Last Update Posted : April 18, 2017
Sponsor:
Information provided by (Responsible Party):
ACADIA Pharmaceuticals Inc.

Brief Summary:
The purpose of this program is to provide patients with PDP access to pimavanserin until the product receives marketing approval from the FDA and is commercially available.

Condition or disease Intervention/treatment
Parkinson's Disease Psychosis Drug: Pimavanserin tartrate

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Study Type : Expanded Access
Official Title: Expanded Access Program of Pimavanserin in Patients With Parkinson's Disease Psychosis



Intervention Details:
  • Drug: Pimavanserin tartrate
    Pimavanserin tartrate 40 mg, tablet, taken as two 20 mg tablets, once daily by mouth

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  1. Patient meets one of the following criteria:

    1. Patient has participated in a previous study of pimavanserin for Parkinson's disease psychosis (PDP)
    2. New ("De novo") patients
  2. A clinical diagnosis of Parkinson's disease with a minimum duration of 1 year
  3. Female patients must be of non-childbearing potential
  4. Psychotic symptoms must have developed after Parkinson's disease diagnosis was established
  5. Patient that has received stereotaxic surgery for subthalamic nucleus deep brain stimulation must be at least 6 months post-surgery and the stimulator settings must have been stable for at least 1 month prior to Study Day 1 (Baseline) and must remain stable during the trial
  6. The patient or Legally Authorized Representative (LAR) is willing and able to provide consent
  7. The patient or LAR is willing and able to adequately communicate in English.

Exclusion Criteria:

  1. Patient has a history of significant psychotic disorders prior to or concomitantly with the diagnosis of Parkinson's disease including, but not limited to, schizophrenia or bipolar disorder
  2. Patient has had dementia prior to or concurrently with their diagnosis of Parkinson's disease that may be inconsistent with a Parkinson's diagnosis
  3. Patient has current evidence of a serious and/or unstable cardiovascular, respiratory, gastrointestinal, renal, hematologic, or other medical disorder, including cancer or malignancies, which would affect the patient's ability to participate in the program
  4. Patient has had a myocardial infarction in last six months
  5. Patient has any surgery planned during the screening, treatment, or follow-up periods

Patients will be evaluated at screening to ensure that all criteria for study participation are met. These evaluations will include specific measures of psychosis severity, delirium, dementia, cardiovascular condition, and pregnancy status. Patients may be excluded from the study based on these assessments (and specifically if it is determined that their baseline health and psychiatric condition do not meet all pre-specified entry criteria).


No Contacts or Locations Provided

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Responsible Party: ACADIA Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT02762591     History of Changes
Other Study ID Numbers: ACP-103-036
First Posted: May 5, 2016    Key Record Dates
Last Update Posted: April 18, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
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Parkinson Disease
Psychotic Disorders
Mental Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Schizophrenia Spectrum and Other Psychotic Disorders
Pimavanserin
Antiparkinson Agents
Anti-Dyskinesia Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action