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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 October 2017
Main ID:  NCT00125138
Date of registration: 27/07/2005
Prospective Registration: No
Primary sponsor: Lundbeck LLC
Public title: Melperone (an Anti-Psychotic) in Patients With Psychosis Associated With Parkinson's Disease
Scientific title: Safety and Efficacy of Melperone in the Treatment of Patients With Psychosis Associated With Parkinson's Disease
Date of first enrolment: July 2005
Target sample size: 90
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00125138
Study type:  Interventional
Study design:   
Phase:  Phase 2
Countries of recruitment
India Italy United States
Contacts
Name:     Email contact via H. Lundbeck A/S
Address: 
Telephone:
Email:
Affiliation:  LundbeckClinicalTrials@lundbeck.com
Key inclusion & exclusion criteria

Inclusion Criteria:

- The subject or subject's legally authorized representative (LAR) must sign and date
the IRB/IEC approved Informed Consent Form and HIPAA Authorization (applicable to US
sites only) prior to study participation.

- Male or female subjects. If female:

- Subject is either not of childbearing potential, defined as postmenopausal for at
least 1 year or surgically sterile (bilateral tubal ligation, bilateral
oophorectomy or hysterectomy), or if of childbearing potential, must comply with
a method of birth control acceptable to the investigator during the study, for at
least one month prior to randomization and for one month following completion of
the study.

- Subject is not breastfeeding

- Subjects of childbearing potential must have a negative serum pregnancy test at
the screening visit and on Day 1.

- Subjects with a clinical diagnosis of idiopathic Parkinson's Disease, defined as the
presence of at least three of the following cardinal features, in the absence of
alternative explanations or atypical features:

- Rest tremor

- Rigidity

- Bradykinesia and/or akinesia

- Postural and gait abnormalities

- Subjects with psychosis:

- Presence of visual and/or auditory hallucinations, with or without delusions,
occurring during the four weeks prior to the screening visit.

- Symptoms severe enough to clinically warrant treatment with an antipsychotic
agent.

- A Hallucinations or Delusions total item score (frequency x severity) of > 4 on
the Neuropsychiatric Inventory (NPI).

- Subjects currently being treated with an antipsychotic agent who have not
had visual and/or auditory hallucinations, with or without delusions, during
the four weeks prior to screening, and/or have a Hallucinations or Delusions
total item score <4 on the NPI at the screening visit may be washed out (for
7 days or 5 half-lives, whichever is longer) and return for a repeat
screening visit. The NPI Hallucinations or Delusions total item score must
be =4 at the repeat visit to be considered for study entry.

- Subject is on a stable dose of anti-Parkinsonian medication(s) for at least 7 days or
5 half-lives, whichever is longer, prior to the screening visit and is expected to
remain on a stable dose for the duration of the study.

- Subject is willing and able to comply with all study procedures.

Exclusion Criteria:

- Subject has any systemic factor contributing to the psychosis such as urinary
infection, liver disease, renal failure, anemia, infection or cancer.

- Subject has a history of significant psychotic disorders prior to the diagnosis of
Parkinson's Disease, including but not limited to schizophrenia or bipolar disorder.

- Subject has Dementia with Lewy-bodies (DLB).

- Subject has dementia or a major depressive disorder precluding accurate assessment on
rating scales.

- Subject has an acute depressive episode at the time of the screening visit.

- A score on the Mini-Mental State Examination (MMSE) of < 21.

- Subject has had a dose adjustment of their antidepressant medication within 30 days
prior to the screening visit, or dose adjustments are planned during the duration of
the trial.

- Subject has had dose adjustments of an anxiolytic, cognitive enhancer, or other
psychotropic medication (excluding antipsychotics) within 30 days prior to screening
or dose adjustments are planned during the duration of the trial.

- Subject has received depot antipsychotic agents within the past 3 months.

- Subject has previously failed treatment with clozaril for psychosis in Parkinson's
disease. Subjects who discontinued clozaril due to intolerability may be enrolled.

- Subject has used any investigational product within 30 days or 5 half-lives, whichever
is longer, prior to screening.

- Subject cannot tolerate a wash-out of antipsychotic medication prior to randomization.

- Subject has a history of a serious respiratory, gastrointestinal, renal, hematologic
or other medical disorder.

- Subject has a history of a serious cardiovascular condition (including, but not
limited to, Class IV angina or Class IV heart failure) and/or a history of risk
factors for Torsade de pointes (Tdp) (including but not limited to current treatment
for hypokalemia or family history of long QT syndrome).

- Subject had myocardial infarction within 6 months prior to screening.

- Subject has a screening ECG with corrected QT interval by Bazett's correction formula
(QTcB) of greater than 450 msec, if female, or 430 msec, if male.

- Subject requires treatment with an a-agonist agent.

- Subject has uncontrolled seizures, uncontrolled angina, or uncontrolled symptomatic
orthostatic hypotension (or orthostatic hypotension leading to a history of falls 3
months prior to screening), or other medical disorders which would make the subject a
poor candidate for a clinical trial.

- Subject has a history of severe adverse reactions to antipsychotic medications and/or
quinine.

- Subject has clinically significant abnormal laboratory values, ECG, or findings on
physical exam.

- Subject has a recent history or current evidence of substance dependence or abuse.

- Subject is unable to ingest liquid medication.

- Subject is currently being treated with Deep Brain Stimulation (DBS).

Randomization Criteria

- Subject has a Hallucinations or Delusions total item score (frequency x severity) of >
4 on the NPI.

- Female subjects of childbearing potential must have a negative serum pregnancy test.

- Subject has remained on a stable dose of anti-Parkinsonian medications.

- Subject has not had a dose adjustment in their antidepressant medication since the
screening visit.

- Subjects have been washed out of previous antipsychotic agents for 5 half-lives or 7
days, whichever is longer, after the last dose of medication.

- Subject has not had dose adjustments in an anxiolytic, cognitive enhancer or other
psychotropic medication (excluding antipsychotics) since the Screening Visit.



Age minimum: N/A
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Parkinson's Disease
Psychotic Disorders
Intervention(s)
Drug: Melperone HCl
Drug: Placebo
Primary Outcome(s)
Patient Evaluation of Symptoms of Psychosis. [Time Frame: 6 weeks (from Baseline to end of Maintenance Period)]
Secondary Outcome(s)
Investigator/Caregiver Evaluations of Motor Function [Time Frame: 6 weeks (from Baseline to end of Maintenance Period)]
Secondary ID(s)
13104A
OV1003
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 17/06/2011
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00125138
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