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Parkinson's Disease PsychosisPhase 3NCT01174004

A Study of the Safety and Efficacy of Pimavanserin in Patients With Parkinson's Disease Psychosis

A Phase 3 study testing pimavanserin tartrate in people with Parkinson's Disease Psychosis, run by ACADIA Pharmaceuticals Inc. at 63 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the safety and efficacy of 40 mg pimavanserin compared to placebo in patients with Parkinson's disease psychosis (PDP). Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Parkinson's Disease Psychosis
What is being tested?
pimavanserin tartrate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
199 participants
Where
63 sitesin 2 countries
Study dates
Jul 2010to Nov 2012
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • A clinical diagnosis of Parkinson's disease with a minimum duration of 1 year
  • Presence of visual and/or auditory hallucinations, and/or delusions, occurring during the four weeks prior to study screening
  • Psychotic symptoms must have developed after Parkinson's disease diagnosis was established
  • Subjects that are on anti-Parkinson's medication must be on a stable dose for 1 month prior to Study Day 1 (Baseline) and during the trial
  • Subject 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
  • The subject is willing and able to provide consent
  • Caregiver is willing and able to accompany the subject to all visits
  • Subject and caregiver are willing and able to adequately communicate in English for the purposes of the primary assessment

Who cannot join

  • Subject 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
  • Subject has received previous ablative stereotaxic surgery (i.e., pallidotomy and thalamotomy) to treat Parkinson's disease
  • Subject has current evidence of a serious and or unstable cardiovascular, respiratory, gastrointestinal, renal, hematologic or other medical disorder
  • Subject has had a myocardial infarction in last six months
  • Subject 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 protocol-specified entry criteria).

Trial locations and contacts

63 sites in 2 countries.

63 sites in 2 countries

United States62 sites

  • Study site

    Albany, New York, 12208

  • Study site

    Alexandria, Virginia, 22311

  • Study site

    Augusta, Georgia, 30912

  • Study site

    Baltimore, Maryland, 21287

  • Study site

    Boca Raton, Florida, 33486

  • Study site

    Boston, Massachusetts, 02215

  • Study site

    Bradenton, Florida, 34205

  • Study site

    Brentwood, Tennessee, 37027

  • Study site

    Carson, California, 90746

  • Study site

    Cincinnati, Ohio, 45219

  • Study site

    Cleveland, Ohio, 44195

  • Study site

    Columbus, Ohio, 43210

  • Study site

    Commack, New York, 11725

  • Study site

    Danbury, Connecticut, 06810

  • Study site

    Decatur, Georgia, 30033

  • Study site

    Durham, North Carolina, 27705

  • Study site

    Elk Grove Village, Illinois, 60007

  • Study site

    Flowood, Mississippi, 39232

  • Study site

    Fountain Valley, California, 92708

  • Study site

    Fresno, California, 93720

  • Study site

    Fullerton, California, 92835

  • Study site

    Gilbert, Arizona, 85234

  • Study site

    Glenview, Illinois, 60026

  • Study site

    Greensburg, Pennsylvania, 15601

  • Study site

    Houston, Texas, 77030

  • Study site

    Irvine, California, 92697

  • Study site

    Kansas City, Kansas, 66160

  • Study site

    Kingston, New York, 12401

  • Study site

    La Habra, California, 90631

  • Study site

    La Jolla, California, 92037

  • Study site

    Loma Linda, California, 92354

  • Study site

    Louisville, Kentucky, 40202

  • Study site

    Milwaukee, Wisconsin, 53233

  • Study site

    Missoula, Montana, 59802

  • Study site

    Naples, Florida, 34102

  • Study site

    New York, New York, 10016

  • Study site

    Novi, Michigan, 48377

  • Study site

    Orlando, Florida, 32806

  • Study site

    Ormond Beach, Florida, 32174

  • Study site

    Oxnard, California, 93030

  • Study site

    Panama City, Florida, 32405

  • Study site

    Pasadena, California, 91105

  • Study site

    Phoenix, Arizona, 85004

  • Study site

    Phoenix, Arizona, 85013

  • Study site

    Port Charlotte, Florida, 33980

  • Study site

    Providence, Rhode Island, 02906

  • Study site

    Raleigh, North Carolina, 27607

  • Study site

    Reseda, California, 91335

  • Study site

    Roanoke, Virginia, 24018

  • Study site

    Roseville, Michigan, 48066

  • Study site

    Salisbury, North Carolina, 28144

  • Study site

    Salt Lake City, Utah, 84108

  • Study site

    Scarborough, Maine, 04074

  • Study site

    St Louis, Missouri, 63110

  • Study site

    St. Petersburg, Florida, 33713

  • Study site

    Sunnyvale, California, 94085

  • Study site

    Toledo, Ohio, 43614

  • Study site

    Toms River, New Jersey, 08755

  • Study site

    Traverse City, Michigan, 49684

  • Study site

    Tucson, Arizona, 85724

  • Study site

    Ventura, California, 93003

  • Study site

    Virginia Beach, Virginia, 23456

Other trials in United States

Canada1 site

  • Study site

    Ottawa, Ontario, K1G 4G3

Other trials in Canada

About this study

Official title: A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of Pimavanserin in the Treatment of Psychosis in Parkinson's Disease

The purpose of this study is to evaluate the safety and efficacy of 40 mg pimavanserin compared to placebo in patients with Parkinson's disease psychosis (PDP).

Being tested
pimavanserin tartrate, placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pimavanserin tartrateDrug

    Also called ACP-103

    pimavanserin tartrate, 40 mg, tablet, once daily by mouth for 6 weeks

  • placeboDrug

    placebo, tablet, once daily by mouth for 6 weeks

Study groups in NCT01174004
Study groupRoleWhat they receive
1Experimentalpimavanserin tartrate, 40 mg, tablet, once daily by mouth for 6 weeks
Receives: Drug: pimavanserin tartrate
2Placebo comparatorplacebo, tablet, once daily by mouth for 6 weeks
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Antipsychotic Efficacy

    Antipsychotic Efficacy was defined as a decrease in the severity and/or frequency of hallucinations and/or delusions. This is measured as the change from baseline (Day 1) to Day 43 in the Scale for the Assessment of Positive Symptoms 9-item sum score for Parkinson's Disease (SAPS-PD). The possible total score is 0 to 45 and a negative change in score indicates improvement.

    Analysis Method: Mixed Model Repeated Measures (MMRM)

    Measured: Each study visit (i.e. Days 1, 15, 29 and 43)

Secondary outcomes (1)

  1. Motor Symptoms Change From Baseline (Negative = Improvement)

    Motor symptoms were measured using the change from baseline to Day 43 in the combined score of the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) and Part III (Motor Examination). The possible total score is 0 to 160 and a negative change in score indicates improvement.

    Analysis Method: Analysis of Covariance (ANCOVA). The UPDRS Parts II+III score was analyzed by constructing 2-sided 95% confidence intervals (CIs) on the difference between the pimavanserin dose group and placebo mean change from baseline. Non-inferiority was concluded if the upper limit of the CI was less than or equal to 5.

    Measured: Study Days 1 and 43

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2010 (estimated)
  2. Study startJul 2010
  3. Primary completionNov 2012
  4. Study completionNov 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
199 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01174004
Sponsor's protocol ID
ACP-103-020
Status last verified
Feb 2014
First submitted
30 Jul 2010
Last updated
26 Mar 2014
Data monitoring committee
No

Publications

  • Cummings J, Isaacson S, Mills R, Williams H, Chi-Burris K, Corbett A, Dhall R, Ballard C. Pimavanserin for patients with Parkinson's disease psychosis: a randomised, placebo-controlled phase 3 trial. Lancet. 2014 Feb 8;383(9916):533-40. doi: 10.1016/S0140-6736(13)62106-6. Epub 2013 Nov 1.

    PubMed 24183563

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing pimavanserin tartrate in people with Parkinson's Disease Psychosis, run by ACADIA Pharmaceuticals Inc. at 63 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 63 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Antipsychotic Efficacy (time frame: Each study visit (i.e. Days 1, 15, 29 and 43)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01174004, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2014.

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