Parkinson's DiseasePhase 4NCT00095810
Aripiprazole in Patients With Psychosis Associated With Parkinson's Disease
A Phase 4 study testing aripiprazole in people with Parkinson's Disease and Psychoses, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 1 site in United States.
Trial summary
The purpose of this clinical research study is to assess the safety and tolerability of aripiprazole in patients with psychosis associated with Parkinson's disease. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Parkinson's Disease, Psychoses
- What is being tested?
- aripiprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2003to Sep 2004
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary diagnosis of idiopathic Parkinson's disease.
- Psychosis related to Parkinson's disease.
Who cannot join
- Psychosis present prior to diagnosis of Parkinson's disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label Study of Aripiprazole to Evaluate the Safety and Tolerability in Patients With Psychosis Associated With Parkinson's Disease
The purpose of this clinical research study is to assess the safety and tolerability of aripiprazole in patients with psychosis associated with Parkinson's disease.
- Conditions
- Parkinson's Disease, Psychoses
- Being tested
- aripiprazole
- Keywords
- Psychosis, Parkinson's Disease
- Medical subject headings
- Parkinson Disease, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aripiprazoleDrug
Also called Abilify
Tablets, Oral, 1-10mg, Once daily, 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: aripiprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability
Secondary outcomes (1)
Safety Assessments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2004 (estimated)
- Study startJul 2003
- Primary completionSep 2004
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.The sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Otsuka America Pharmaceutical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00095810
- Sponsor's protocol ID
- CN138-060
- Status last verified
- Dec 2010
- First submitted
- 9 Nov 2004
- Last updated
- 8 Nov 2013
- Results posted
- No
Publications
Friedman JH, Berman RM, Goetz CG, Factor SA, Ondo WG, Wojcieszek J, Carson WH, Marcus RN. Open-label flexible-dose pilot study to evaluate the safety and tolerability of aripiprazole in patients with psychosis associated with Parkinson's disease. Mov Disord. 2006 Dec;21(12):2078-81. doi: 10.1002/mds.21091.
PubMed 17013906
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study of Aripiprazole to Evaluate the Safety and Tolerability in Patients With Psychosis Associated With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT00095810
- Acronym / sponsor ID
- CN138-060
- Conditions
- Parkinson's Disease, Psychoses
- Keywords
- Psychosis, Parkinson's Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Otsuka America Pharmaceutical
- Study start
- Jul 2003
- Primary completion
- Sep 2004 (actual)
- Study completion
- Sep 2004 (actual)
- First posted
- 9 Nov 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical research study is to assess the safety and tolerability of aripiprazole in patients with psychosis associated with Parkinson's disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: aripiprazole |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Primary diagnosis of idiopathic Parkinson's disease.
- Psychosis related to Parkinson's disease.
Key exclusion criteria (1 listed)
- Psychosis present prior to diagnosis of Parkinson's disease.
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 |
|---|---|---|
| aripiprazoleAlso: AbilifyTablets, Oral, 1-10mg, Once daily, 6 weeks. | Drug | A |
Primary outcome
Tolerability
1 secondary outcome
Safety Assessments
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2013.
- Background: PubMed 17013906Friedman JH, Berman RM, Goetz CG, Factor SA, Ondo WG, Wojcieszek J, Carson WH, Marcus RN. Open-label flexible-dose pilot study to evaluate the safety and tolerability of aripiprazole in patients with psychosis associated with Parkinson's disease. Mov Disord. 2006 Dec;21(12):2078-81. doi: 10.1002/mds.21091.
- PhRMA website-CSR SynopsisLink provided by the sponsor.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing aripiprazole in people with Parkinson's Disease and Psychoses, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 1 site in United States.
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 2 inclusion and 1 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 8 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Tolerability. 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 NCT00095810, 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 8 Nov 2013.