Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00465452
Status:
COMPLETED
Last Update Posted:
2009-03-19
First Post:
2007-04-24
Brief Title:
Impact of Switching to Continuous Release Dopamine Agonists
Sponsor:
University of Toledo Health Science Campus
Organization:
University of Toledo
Study Overview
Official Title:
The Impact of Switching to Continuous Release Dopamine Agonists on Non-Motor Side Effects
Status:
COMPLETED
Status Verified Date:
2009-03
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 proposal is to determine if switching PD patients treated with pramipexole to ropinirole CR reduces the non-motor side effects frequently experienced by these patients Side effects that we will monitor in particular include somnolence peripheral edema cognitive decline with and without hallucinations PD patients followed in the MUO Neurology Clinic who are being treated with pramipexole and have evidence of at least one of the following symptoms somnolence cognitive impairment with or without hallucinations or peripheral edema will be offered the opportunity to participate in this study
Detailed Description:
The purpose of this proposal is to determine if switching PD patients treated with pramipexole to ropinirole CR reduces the non-motor side effects frequently experienced by these patients Side effects that we will monitor in particular include somnolence peripheral edema cognitive decline with and without hallucinations PD patients followed in the MUO Neurology Clinic who are being treated with pramipexole and have evidence of at least one of the following symptoms somnolence cognitive impairment with or without hallucinations or peripheral edema will be offered the opportunity to participate in this study
Fifteen subjects who are currently receiving pramipexole therapy monotherapy or adjunctive therapy who are experiencing one or more of the following symptoms somnolence cognitive decline withwithout hallucinations and peripheral edema will be asked if they are willing to participate at the time of their clinic visit at the PDMDP
The crossover from pramipexole to ropinirole CR will be performed over a 2 week interval During the first week the initial drug dose will substitute ½ of the pramipexole with ½ of the target dose of ropinirole CR If subjects are tolerating the drug change then 100 of the target dose of ropinirole CR and no pramipexole will be started in the second week
Fifteen subjects who are currently receiving pramipexole therapy monotherapy or adjunctive therapy who are experiencing one or more of the following symptoms somnolence cognitive decline withwithout hallucinations and peripheral edema will be asked if they are willing to participate at the time of their clinic visit at the PDMDP
The crossover from pramipexole to ropinirole CR will be performed over a 2 week interval During the first week the initial drug dose will substitute ½ of the pramipexole with ½ of the target dose of ropinirole CR If subjects are tolerating the drug change then 100 of the target dose of ropinirole CR and no pramipexole will be started in the second week
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