Impact of Switching to Continuous Release Dopamine Agonists
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00465452|
Recruitment Status : Completed
First Posted : April 25, 2007
Last Update Posted : March 19, 2009
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease||Drug: Continuous Release Dopamine Agonists||Phase 3|
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 with/without 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Impact of Switching to Continuous Release Dopamine Agonists on Non-Motor Side Effects|
|Study Start Date :||January 2007|
|Actual Primary Completion Date :||March 2009|
|Actual Study Completion Date :||March 2009|
Drug: Continuous Release Dopamine Agonists
- Equal or improved motor scores as measured by the Unified Parkinson's Disease Rating Scale (UPDRS), parts 3 (motor performance) and 4 (disability). [ Time Frame: initial visit and repeated at 4, 12, and 24 weeks ]
- A significant improvement in somnolence as measured by the Epworth Sleepiness Scale (ESS). [ Time Frame: initial visit and repeated at 4, 12, and 24 weeks ]
- A significant stabilization or improvement in the cognitive/mood battery of the Mini-Mental Status Exam (MMSE), the Clock Drawing Test (CDT), the Patient Health Questionnaire (PHQ-9) and the Neuropsychiatric Inventory Questionnaire (NPI-Q). [ Time Frame: initial visit and repeated at 4, 12, and 24 weeks ]
- An improvement in peripheral edema, as measured by quantitative assessment of ankle and calf edema. [ Time Frame: initial visit and repeated at 4, 12, and 24 weeks ]
- Increased patient satisfaction/preference (Patient Satisfaction Questionnaire - PS) scores. [ Time Frame: initial visit and repeated at 4, 12, and 24 weeks ]
- Improvement in quality of life (Parkinson's Disease Questionnaire - PDQ-39). [ Time Frame: initial visit and repeated at 4, 12, and 24 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00465452
|United States, Ohio|
|Medical University of Ohio|
|Toledo, Ohio, United States, 43614|
|Principal Investigator:||Lawrence Elmer, MD, PhD||Medical University of Ohio|