Parkinson Disease
Conditions
Keywords
PD, Parkinson's
Brief summary
A conversion study of Mirapex (pramipexole) to Requip (ropinirole) controlled release (CR) in patients with Parkinson's disease to determine the appropriate conversion ratio and side effects related to the drug.
Detailed description
Three different arms will be used in this study. Each of the three cohorts will be treated sequentially. Each participant will be taking Mirapex for PD and will be converted to Requip CR by 1 of 3 conversion factors (mg:mg): 1:3, 1:4 and 1:5 from Mirapex to once a day Requip CR. The first five subjects of each cohort will have their initial dose administered in the clinic and be monitored for orthostatic changes. Assessments of motor function before and after conversion will be done.
Interventions
Sponsors
GlaxoSmithKline
Rajesh Pahwa, MD
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Parkinson Disease * Currently taking pramipexole * Never have taken Requip CR
Exclusion criteria
* Can not have significant adverse effects to standard Requip * Can not have atypical PD due to drugs, metabolic disorders, encephalitis or degenerative diseases * Can not have unstable medical conditions * Can not be taking concurrent monoamine oxidase inhibitors except for selegiline (10mg per day or less) * Female patients of childbearing potential must be using an effective method of contraception. * Can not be pregnant or lactating. This may not be a complete list; there may be additional criteria which may apply.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Effects Experienced | Week 4 | Number of adverse effect experienced by participants in the different conversion ratio groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Dose Adjustments | Week 4 | Outcome measures the number of times a dose needed to be adjusted to compensate for adverse effects experienced. |
Countries
United States
Participant flow
Recruitment details
Patients were enrolled at the University of Kansas Medical Center. Enrollment started in January 2006 and ended in February 2008.
Participants by arm
| Arm | Count |
|---|---|
| Mirapex to Requip 24-Hour of 1:3 Conversion factor of Mirapex to Ropinirole 24-Hour of 1:3 | 20 |
| Mirapex to Requip 24-Hour of 1:4 Conversion factor of Mirapex to Ropinirole 24-Hour of 1:4 | 20 |
| Mirapex to Requip 24-Hour of 1:5 Conversion factor of Mirapex to Ropinirole 24-Hour of 1:5 | 21 |
| Total | 61 |
Baseline characteristics
| Characteristic | Mirapex to Requip 24-Hour of 1:3 | Mirapex to Requip 24-Hour of 1:4 | Mirapex to Requip 24-Hour of 1:5 | Total |
|---|---|---|---|---|
| Age Continuous | 64.1 years STANDARD_DEVIATION 10.1 | 63.9 years STANDARD_DEVIATION 9.7 | 66.2 years STANDARD_DEVIATION 9.7 | 64.7 years STANDARD_DEVIATION 9.7 |
| Region of Enrollment United States | 20 participants | 20 participants | 21 participants | 61 participants |
| Sex: Female, Male Female | 8 Participants | 5 Participants | 5 Participants | 18 Participants |
| Sex: Female, Male Male | 12 Participants | 15 Participants | 16 Participants | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 9 / 33 | 8 / 27 |
| serious Total, serious adverse events | 0 / 33 | 0 / 27 |
Outcome results
Primary
Adverse Effects Experienced
Number of adverse effect experienced by participants in the different conversion ratio groups.
Time frame: Week 4
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Preferred Requip PR | Adverse Effects Experienced | 29 number of events |
| Preferred Mirapex | Adverse Effects Experienced | 43 number of events |
Secondary
Number of Dose Adjustments
Outcome measures the number of times a dose needed to be adjusted to compensate for adverse effects experienced.
Time frame: Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Preferred Requip PR | Number of Dose Adjustments | 0.6 number of adjustments | Standard Deviation 0.7 |
| Preferred Mirapex | Number of Dose Adjustments | 1.3 number of adjustments | Standard Deviation 1.2 |