Parkinson's Disease PsychosisPhase 3NCT00550238
A Study of the Safety and Tolerability of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis
A Phase 3 study testing Pimavanserin tartrate (ACP-103) in people with Parkinson's Disease Psychosis, run by ACADIA Pharmaceuticals Inc. at 135 sites in 14 countries.
Trial summary
To assess the long-term safety and tolerability of ACP-103 in subjects with Parkinson's disease psychosis. 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 (ACP-103)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 459 participants
- Where
- 135 sitesin 14 countries
- Study dates
- Jul 2007to 30 May 2018
- 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
- Subject has completed the treatment period of a previous blinded study of pimavanserin
- The subject is willing and able to provide consent
- Caregiver is willing and able to accompany the subject to all visits
Who cannot join
- Subject has current evidence of a serious and or unstable cardiovascular, respiratory, gastrointestinal, renal, hematologic or other medical disorder
- Subject is judged by the Investigator to be inappropriate for the study
Trial locations and contacts
135 sites in 14 countries.
135 sites in 14 countries
United States83 sites
Study site
Albany, New York, 12208
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Alexandria, Virginia, 22311
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Asheville, North Carolina, 28806
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Augusta, Georgia, 30912
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Baltimore, Maryland, 21287
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Berkeley, California, 94705
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Boca Raton, Florida, 33486
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Boston, Massachusetts, 02215
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Bradenton, Florida, 34205
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Brentwood, Tennessee, 37027
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Burlington, Vermont, 05401
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Carson, California, 90746
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Charlotte, North Carolina, 28204
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Cincinnati, Ohio, 45210
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Cleveland, Ohio, 44195
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Clinton Township, Michigan, 48037
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Columbia, Missouri, 65201
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Columbus, Ohio, 43210
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Commack, New York, 11725
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Danbury, Connecticut, 06810
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Decatur, Georgia, 30033
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Deerfield Beach, Florida, 33064
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Detroit, Michigan, 48201
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Durham, North Carolina, 27705
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East Lansing, Michigan, 48824
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Englewood, Colorado, 80113
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Fairfield, Connecticut, 06824
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Farmington, Connecticut, 06030
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Fountain Valley, California, 92708
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Fresno, California, 93720
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Gainesville, Florida, 32610
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Gilbert, Arizona, 85234
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Glenview, Illinois, 60026
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Greensburg, Pennsylvania, 15601
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Houston, Texas, 77030
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Irvine, California, 92697
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Jacksonville, Florida, 32209
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Kansas City, Kansas, 66160
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Kingston, New York, 12401
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Kirkland, Washington, 98034
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La Habra, California, 90631
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La Jolla, California, 92037
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Laguna Hills, California, 92653
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Loma Linda, California, 92354
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Louisville, Kentucky, 40202
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Miami, Florida, 33136
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Milwaukee, Wisconsin, 53233
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Missoula, Montana, 59802
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Naples, Florida, 34102
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New Bern, North Carolina, 28562
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Orlando, Florida, 32806
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Ormond Beach, Florida, 32174
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Oxnard, California, 93030
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Panama City, Florida, 32405
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Pasadena, California, 91105
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Philadelphia, Pennsylvania, 19131
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Phoenix, Arizona, 85013
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Pompano Beach, Florida, 33060
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Port Charlotte, Florida, 33980
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Providence, Rhode Island, 02906
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Reseda, California, 91335
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Richmond, Virginia, 23229
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Roanoke, Virginia, 24018
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Rochester, New York, 14618
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Roseville, Michigan, 48066
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Salisbury, North Carolina, 28144
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Salt Lake City, Utah, 84108
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Sarasota, Florida, 34233
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Scarborough, Maine, 04074
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Spokane, Washington, 99204
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Springfield, Illinois, 62794
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St Louis, Missouri, 63110
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St. Petersburg, Florida, 33701
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Sunnyvale, California, 94085
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Tampa, Florida, 33606
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Toledo, Ohio, 43614
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Toms River, New Jersey, 08755
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Traverse City, Michigan, 49684
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Tucson, Arizona, 84724
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Ventura, California, 93003
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Virginia Beach, Virginia, 23456
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West Bloomfield, Michigan, 48334
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Worcester, Massachusetts, 01655
India11 sites
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Bangalore, 560 034
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Chennai, 600 006
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Hyderabad, 500003
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Madurai, 625 020
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Mangalore, 575 001
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Mangalore, 575 002
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Mumbai, 400 016
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Mumbai, 400 026
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Pune, 411 004
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Pune, 411 030
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Visakhapatnam, 530 002
Russia7 sites
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Kazan', 420061
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Kirov, 610014
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Moscow, 125284
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Pyatigorsk, 357538
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Saint Petersburg, 194044
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Samara, 443095
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Smolensk, 214018
Ukraine6 sites
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Kharkiv, 61068
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Kiev, 04080
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Kiev, 04114
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Luhansk, 91045
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Lviv, 79010
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Vinnitsia, 21005
France5 sites
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Clermont-Ferrand, 63003
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Marseille, 13385
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Nantes, 44093
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Pessac, 33604
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Strasbourg, 67091
United Kingdom5 sites
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Barnsley, S75 2EP
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Blackburn, BB2 3HH
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London, NW3 20G
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Newcastle, NE4 6BE
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North Shields, NE21 8NH
Italy4 sites
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Chieti, 66013
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Grosseto, 58100
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Rome, 00163
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Rome, 00185
Poland3 sites
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Bydgoszcz, 85796
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Katowice, 40-752
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Lublin, 20-090
Portugal3 sites
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Coimbra, 3000-548
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Lisbon, 1649-028
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Porto, 4099-001
Canada2 sites
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London, Ontario, N6A 5A5
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Ottawa, Ontario, K1G 4G3
About this study
Official title: A Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson's Disease
To assess the long-term safety and tolerability of ACP-103 in subjects with Parkinson's disease psychosis.
Read the detailed description
This study did not have a fixed duration, and the duration of individual subject participation was determined based on investigator assessment of subject tolerability and continued benefit until such time as either the drug was commercially available in the US, or an alternate treatment extension was available in non-US regions. For this reason, no subjects, therefore, were considered to have "completed" the study.
- Conditions
- Parkinson's Disease Psychosis
- Being tested
- Pimavanserin tartrate (ACP-103)
- Keywords
- Parkinson's Disease Psychosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pimavanserin tartrate (ACP-103)Drug
Tablets taken once daily by mouth for as long as ACP-103 is considered to be tolerated and beneficial to subjects
| Study group | Role | What they receive |
|---|---|---|
| Pimavanserin tartrate (ACP-103) | Experimental | Tablets taken once daily by mouth for as long as ACP-103 is considered to be tolerated and beneficial to subjects Receives: Drug: Pimavanserin tartrate (ACP-103) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Number (%) of Patients With Drug-related Treatment-emergent Adverse Events (AEs)
Number (%) of patients with drug-related treatment-emergent AEs (i.e. AEs reported by the Investigator as possibly, probably, or highly probably related to study drug)
Measured: From first to last study drug dose plus 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2007 (estimated)
- Study startJul 2007
- Primary completion30 May 2018
- Study completion30 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson's Disease PsychosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 459 participants (actual)
Sponsor and investigators
- Lead sponsor
- ACADIA Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00550238
- Sponsor's protocol ID
- ACP-103-015
- Status last verified
- May 2019
- First submitted
- 26 Oct 2007
- Last updated
- 24 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mathis MV, Muoio BM, Andreason P, Avila AM, Farchione T, Atrakchi A, Temple RJ. The US Food and Drug Administration's Perspective on the New Antipsychotic Pimavanserin. J Clin Psychiatry. 2017 Jun;78(6):e668-e673. doi: 10.4088/JCP.16r11119.
PubMed 28493654Ballard C, Isaacson S, Mills R, Williams H, Corbett A, Coate B, Pahwa R, Rascol O, Burn DJ. Impact of Current Antipsychotic Medications on Comparative Mortality and Adverse Events in People With Parkinson Disease Psychosis. J Am Med Dir Assoc. 2015 Oct 1;16(10):898.e1-7. doi: 10.1016/j.jamda.2015.06.021. Epub 2015 Aug 1.
PubMed 26239690
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT00550238
- Acronym / sponsor ID
- ACP-103-015
- Conditions
- Parkinson's Disease Psychosis
- Keywords
- Parkinson's Disease Psychosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 459 participants (actual)
- Lead sponsor
- ACADIA Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 29 Oct 2007 (estimated)
- Results
- Posted 24 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the long-term safety and tolerability of ACP-103 in subjects with Parkinson's disease psychosis.
Detailed description
This study did not have a fixed duration, and the duration of individual subject participation was determined based on investigator assessment of subject tolerability and continued benefit until such time as either the drug was commercially available in the US, or an alternate treatment extension was available in non-US regions. For this reason, no subjects, therefore, were considered to have "completed" the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pimavanserin tartrate (ACP-103) | Experimental | Drug: Pimavanserin tartrate (ACP-103)Tablets taken once daily by mouth for as long as ACP-103 is considered to be tolerated and beneficial to subjects |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject has completed the treatment period of a previous blinded study of pimavanserin
- The subject is willing and able to provide consent
- Caregiver is willing and able to accompany the subject to all visits
Key exclusion criteria (2 listed)
- Subject has current evidence of a serious and or unstable cardiovascular, respiratory, gastrointestinal, renal, hematologic or other medical disorder
- Subject is judged by the Investigator to be inappropriate for the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pimavanserin tartrate (ACP-103)Tablets taken once daily by mouth for as long as ACP-103 is considered to be tolerated and beneficial to subjects | Drug | Pimavanserin tartrate (ACP-103) |
Primary outcome
Safety: Number (%) of Patients With Drug-related Treatment-emergent Adverse Events (AEs)
Time frame: From first to last study drug dose plus 30 days
Number (%) of patients with drug-related treatment-emergent AEs (i.e. AEs reported by the Investigator as possibly, probably, or highly probably related to study drug)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28493654Mathis MV, Muoio BM, Andreason P, Avila AM, Farchione T, Atrakchi A, Temple RJ. The US Food and Drug Administration's Perspective on the New Antipsychotic Pimavanserin. J Clin Psychiatry. 2017 Jun;78(6):e668-e673. doi: 10.4088/JCP.16r11119.
- Derived from this study: PubMed 26239690Ballard C, Isaacson S, Mills R, Williams H, Corbett A, Coate B, Pahwa R, Rascol O, Burn DJ. Impact of Current Antipsychotic Medications on Comparative Mortality and Adverse Events in People With Parkinson Disease Psychosis. J Am Med Dir Assoc. 2015 Oct 1;16(10):898.e1-7. doi: 10.1016/j.jamda.2015.06.021. Epub 2015 Aug 1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
135 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pimavanserin tartrate (ACP-103) in people with Parkinson's Disease Psychosis, run by ACADIA Pharmaceuticals Inc. at 135 sites in 14 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 3 inclusion and 2 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 24 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 135 sites in United States, India, Russia, Ukraine, France and 9 more countries. 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. 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 24 Jun 2019). 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?
Safety: Number (%) of Patients With Drug-related Treatment-emergent Adverse Events (AEs) (time frame: From first to last study drug dose plus 30 days). 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 NCT00550238, which also lists 2 linked publications.
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 24 Jun 2019.