NCT00465452

Impact of Switching to Continuous Release Dopamine Agonists

The Impact of Switching to Continuous Release Dopamine Agonists on Non-Motor Side Effects

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: University of Toledo · Academic / Other
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DRUG	Continuous Release Dopamine Agonists	Continuous Release Dopamine Agonists

Timeline

• Start date: 2007-01-01
• Primary completion: 2009-03-01
• Completion: 2011-12-01
• First posted: 2007-04-25
• Last updated: 2025-05-16
• Results posted: 2025-05-16

Locations

1 site across 1 country: United States