HallucinationsPhase 2NCT00087542
Treatment of Hallucinosis/Psychosis in Parkinson's Disease by an Investigational Drug
A Phase 2 study testing ACP-103 in people with Hallucinations and Psychoses, run by ACADIA Pharmaceuticals Inc. at 13 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Hallucinations, Psychoses, Parkinson's Disease
- What is being tested?
- ACP-103
- How many people
- 60 participants
- Where
- 13 sitesUnited States
- Study dates
- Mar 2004to Dec 2005
- Phase
- Phase 2
- 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 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Study site
Albany, New York, 12205
Study site
Asheville, North Carolina, 28806
Study site
Atlanta, Georgia, 30329
Study site
Brentwood, Tennessee, 37027
Study site
Danbury, Connecticut, 06810
Study site
Elkridge, Maryland, 21075
Study site
Fountain Valley, California, 92708
Study site
Kansas City, Kansas, 66160
Study site
Pawtucket, Rhode Island, 02860
Study site
Philadelphia, Pennsylvania, 19107
Study site
Pompano Beach, Florida, 33060
Study site
Sunnyvale, California, 94089
Study site
Tampa, Florida, 33606
About this study
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.
Read the 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.
- Conditions
- Hallucinations, Psychoses, Parkinson's Disease
- Being tested
- ACP-103
- Keywords
- Hallucinosis/Psychosis
- Medical subject headings
- Hallucinations, Psychotic Disorders, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACP-103Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
ACP-103 is an effective treatment for Parkinson's Disease with psychosis
Secondary outcomes (1)
ACP-103 does not cause worsening of motor function in Parkinson's Disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2004 (estimated)
- Study startMar 2004
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HallucinationsStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- ACADIA Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00087542
- Sponsor's protocol ID
- ACP-103-006
- Status last verified
- Dec 2005
- First submitted
- 9 Jul 2004
- Last updated
- 7 Dec 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Hallucinosis/Psychosis in Parkinson's Disease by an Investigational Drug
- ClinicalTrials.gov ID
- NCT00087542
- Acronym / sponsor ID
- ACP-103-006
- Conditions
- Hallucinations, Psychoses, Parkinson's Disease
- Keywords
- Hallucinosis/Psychosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- ACADIA Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2004
- Study completion
- Dec 2005
- First posted
- 14 Jul 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 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
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 |
|---|---|---|
| ACP-103 | Drug | – |
Primary outcome
ACP-103 is an effective treatment for Parkinson's Disease with psychosis
1 secondary outcome
ACP-103 does not cause worsening of motor function in Parkinson's Disease
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 7 Dec 2005.
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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.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ACP-103 in people with Hallucinations and Psychoses, run by ACADIA Pharmaceuticals Inc. at 13 sites 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 6 inclusion and 15 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 7 Dec 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
ACP-103 is an effective treatment for Parkinson's Disease with psychosis. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Dec 2005.