Phase 2
N=90
Melperone (an Anti-Psychotic) in Patients With Psychosis Associated With Parkinson's Disease
Parkinson's Disease · Psychotic Disorders
Bottom Line
View on ClinicalTrials.gov: NCT00125138 ↗Enrolled (actual)
90
Serious AEs
6.7%
Results posted
Jun 2011
Primary outcome: Primary: Patient Evaluation of Symptoms of Psychosis. — -9.8; -12.9; -9.7; -10.0 Scores on a scale — p=0.5177
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Melperone HCl (Drug); Placebo (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Lundbeck LLC
- Primary completion
- Mar 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Evaluation of Symptoms of Psychosis. |
-9.8; -12.9; -9.7; -10.0 | 0.5177 |
| SECONDARY Investigator/Caregiver Evaluations of Motor Function |
0.7; 1.8; 0.9; 0.5 | 0.9212 |
Summary
The purpose of this study is to evaluate the safety and efficacy of three target doses of melperone compared to placebo in the treatment of psychosis associated with Parkinson's disease. Subjects will be enrolled at approximately 20 investigational sites in the United States (U.S.) and 15 Ex-US sites. The maximum study duration will be 10 weeks. Subjects will have the option of continuing in an open-label extension study.
Eligibility 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.
- 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.
Data sourced from ClinicalTrials.gov (NCT00125138). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.