Pramipexole Conversion to Ropinirole CR
Information source: University of Kansas
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Parkinson Disease
Intervention: Ropinirole controlled release (CR) (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: University of Kansas Official(s) and/or principal investigator(s):
Rajesh Pahwa, MD, Principal Investigator, Affiliation: University of Kansas
Overall contact:
April Langhammer, Phone: 913-588-6989, Email: alanghammer@kumc.edu
Summary
A conversion study of pramipexole to ropinirole controlled release (CR) in patients with
Parkinson's disease to determine the appropriate conversion ratio and side effects related to
the drug.
Clinical Details
Official title: An Open Label Conversion Study of Pramipexole to Ropinirole Controlled Release (CR) in Patients With Parkinson's Disease.
Study design: Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Efficacy Study
Primary outcome: Primary outcome variables to examine the efficacy of ropinirole will be the PDQ-39 and global rating scales
Secondary outcome: Parkinsonian rating scales and adverse events
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 pramipexole for PD and will be converted to
ropinirole CR by 1 of 3 conversion factors (mg: mg): 1: 3, 1: 4 and 1: 5 from pramipexole to
once a day ropinirole 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Diagnosis of Parkinson Disease
- Currently taking pramipexole
- Never have taken ropinirole CR
Exclusion Criteria:
- Can not have significant adverse effects to standard ropinirole
- 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.
Locations and Contacts
April Langhammer, Phone: 913-588-6989, Email: alanghammer@kumc.edu
University of Kansas Medical Center, Kansas City, Kansas 66160, United States; Recruiting
April Langhammer, Phone: 913-588-6989, Email: alanghammer@kumc.edu
Rajesh Pahwa, MD, Principal Investigator
Additional Information
Starting date: January 2006
Ending date: March 2008
Last updated: December 28, 2007
|
