Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00125138
Status:
COMPLETED
Last Update Posted:
2011-06-17
First Post:
2005-07-27
Brief Title:
Melperone an Anti-Psychotic in Patients With Psychosis Associated With Parkinsons Disease
Sponsor:
Lundbeck LLC
Organization:
Lundbeck LLC
Study Overview
Official Title:
Safety and Efficacy of Melperone in the Treatment of Patients With Psychosis Associated With Parkinsons Disease
Status:
COMPLETED
Status Verified Date:
2011-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Parkinsons disease Subjects will be enrolled at approximately 20 investigational sites in the United States US 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
Detailed Description:
Parkinsons Disease is a progressive neurodegenerative disorder characterized by bradykinesia rigidity tremor and abnormal posture and gait Many patients can have mild to moderate symptoms while others with advanced disease have symptoms which interfere with activities of daily living to a severe degree Although effective in addressing motor dysfunction long-term use of anti-Parkinsonian agents has been implicated as a component in the development of psychiatric side effects including psychosis Treatment of psychosis with typical antipsychotics is not recommended in this patient population since even low potency typical antipsychotics can cause marked exacerbations of parkinsonism in Parkinsons disease patients The use of atypical antipsychotics eg clozapine risperidone and quetiapine has shown some efficacy in the treatment of psychosis in PD patients Melperone is classified atypical antipsychotic European experience with melperone spans more than 30 years and it encompasses an established antipsychotic efficacy profile in the treatment of confusion anxiety unrest particularly in the elderly and schizophrenia as well as a favorable safety and tolerability profile Eligible subjects with Parkinsons disease psychosis will participate in a 1-2 week ScreeningWashout Period a 5 week Titration Phase one of three doses of melperone or placebo a 1 week Maintenance Phase and a TaperFollow-up Period up to 2 weeks Following the Day 43 assessment subjects may be given the option of receiving melperone in an open-label extension study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| OV1003 | OTHER | Former study ID | None |