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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Conversion factor of Mirapex to Requip 24-Hour of 1:3. This was a switch study in which the conversion factor was being investigated to assist in the conversion from Mirapex to Requip PR. In this group, the dose of Requip PR was 3 times the dose of Mirapex. |
|
| 2 | Experimental | Conversion factor of Mirapex to Requip 24-Hour of 1:4 |
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| 3 | Experimental | Conversion factor of Mirapex to Requip 24-Hour of 1:5 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Requip PR | Drug | Requip 24-Hour once a day for one month |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Effects Experienced | Number of adverse effect experienced by participants in the different conversion ratio groups. | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Dose Adjustments | Outcome measures the number of times a dose needed to be adjusted to compensate for adverse effects experienced. | Week 4 |
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Inclusion Criteria:
Exclusion Criteria:
This may not be a complete list; there may be additional criteria which may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Rajesh Pahwa, MD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
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Patients were enrolled at the University of Kansas Medical Center. Enrollment started in January 2006 and ended in February 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mirapex to Requip 24-Hour of 1:3 | Conversion factor of Mirapex to Ropinirole 24-Hour of 1:3 |
| FG001 | Mirapex to Requip 24-Hour of 1:4 | Conversion factor of Mirapex to Ropinirole 24-Hour of 1:4 |
| FG002 | Mirapex to Requip 24-Hour of 1:5 | Conversion factor of Mirapex to Ropinirole 24-Hour of 1:5 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mirapex to Requip 24-Hour of 1:3 | Conversion factor of Mirapex to Ropinirole 24-Hour of 1:3 |
| BG001 | Mirapex to Requip 24-Hour of 1:4 | Conversion factor of Mirapex to Ropinirole 24-Hour of 1:4 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Adverse Effects Experienced | Number of adverse effect experienced by participants in the different conversion ratio groups. | Posted | Number | number of events | Week 4 |
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|
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There were a total of 61 participants enrolled to the study. One participant was removed from the study before he started study related procedures. Due to that, a total of 60 participants had adverse event data recorded.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Preferred Requip PR | These are the subjects that preferred Requip PR to Mirapex at the end of the study |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| PD worsening | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kelly E. Lyons, PhD | University of Kansas Medical Center | 913-588-7159 | klyons@kumc.edu |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C046649 | ropinirole |
| D000077487 | Pramipexole |
| ID | Term |
|---|---|
| D052160 | Benzothiazoles |
| D013844 | Thiazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Mirapex | Drug | All subjects started the study on Mirapex. They were all then switched to Requip PR based on a conversion factor of 1:3, 1:4 or 1:5. |
|
|
| BG002 | Mirapex to Requip 24-Hour of 1:5 | Conversion factor of Mirapex to Ropinirole 24-Hour of 1:5 |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Participants |
|
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| Secondary | Number of Dose Adjustments | Outcome measures the number of times a dose needed to be adjusted to compensate for adverse effects experienced. | Posted | Mean | Standard Deviation | number of adjustments | Week 4 |
|
|
|
| 0 |
| 33 |
| 9 |
| 33 |
| EG001 | Preferred Mirapex | These are the subjects that preferred Mirapex to Requip PR at the end of the study | 0 | 27 | 8 | 27 |
| Dizziness | General disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Somnolence | General disorders | Systematic Assessment |
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| Anxiety | General disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Edema | General disorders | Systematic Assessment |
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| Headache | General disorders | Systematic Assessment |
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| Heartburn | Gastrointestinal disorders | Systematic Assessment |
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| Insomnia | Gastrointestinal disorders | Systematic Assessment |
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| Weakness | General disorders | Systematic Assessment |
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| Confusion | General disorders | Systematic Assessment |
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| Disorientation | General disorders | Systematic Assessment |
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| Dyskinesia | General disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Hallucinations | General disorders | Systematic Assessment |
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| Leg Cramps | General disorders | Systematic Assessment |
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| Slow kick in | General disorders | Systematic Assessment |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D006571 |
| Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |