Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00087542
Status:
COMPLETED
Last Update Posted:
2005-12-07
First Post:
2004-07-09
Brief Title:
Treatment of HallucinosisPsychosis in Parkinsons Disease by an Investigational Drug
Sponsor:
ACADIA Pharmaceuticals Inc
Organization:
ACADIA Pharmaceuticals Inc
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Parkinsons disease and psychosis The secondary objectives are to determine whether ACP-103 will ameliorate psychosis in patients with Parkinsons disease and whether ACP-103 is safe in Parkinsons 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 Parkinsons 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 screeningbaseline 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 Parkinsons 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 patients daily level of function These factors argue for the safe inclusion of a four-week period of placebo treatment
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 screeningbaseline 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 Parkinsons 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 patients daily level of function These factors argue for the safe inclusion of a four-week period of placebo treatment
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