Back to resultsOpen Label High Dose Ropinirole (Requip) Study for Patients With Parkinson's Disease
Primary Purpose
Parkinson's Disease
Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ropinirole Hydrochloride
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Ropinirole, Parkinson's disease, dopamine agonist
Eligibility Criteria
Inclusion Criteria: Patients must give written informed consent prior to any specific study procedures. Males or females; females of childbearing age who are not currently pregnant must agree to use a medically accepted method of contraception throughout the study. Age greater than or equal to 25 years. Patients must be on a maximum dose of dopamine agonist drug (pergolide 4mg/day, pramipexole 4.5 mg/day or ropinirole 24mg/day). Stable dose of all medications for 4 weeks. Exclusion Criteria: Current hallucinations. History of disabling hallucinations or hallucinations in past requiring treatment. Troublesome edema (swelling). Unstable depression. Female who is pregnant or lactating. Use of an investigational drug with in the last 30 days. Other inclusion or exclusion criteria to be evaluated by the physician.
Sites / Locations
- Colorado Neurology, P.C.Recruiting
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00260793
First Posted
December 1, 2005
Last Updated
February 2, 2006
Sponsor
Agarwal, Pinky, M.D.
Collaborators
Colorado Neurology, GlaxoSmithKline
1. Study Identification
Unique Protocol Identification Number
NCT00260793
Brief Title
Open Label High Dose Ropinirole (Requip) Study for Patients With Parkinson's Disease
Official Title
Open Label Prospective Study of High Dose Ropinirole for Motor Fluctuations and Dyskinesias in Advanced Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
November 2005
Overall Recruitment Status
Unknown status
Study Start Date
November 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Agarwal, Pinky, M.D.
Collaborators
Colorado Neurology, GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
The purpose of this research study is to see if subjects with Parkinson's disease who are experiencing motor fluctuations ("on" and "off" states) and dyskinesias (involuntary excessive movements) would benefit from a higher dose of Requip as compared to the maximum FDA approved dose of dopamine agonist drugs (including Requip, Mirapex, and Permax). Requip as used in this study is investigational, which means it has not been approved by the US Food and Drug Administration (FDA) at this dose level.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Ropinirole, Parkinson's disease, dopamine agonist
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Ropinirole Hydrochloride
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients must give written informed consent prior to any specific study procedures.
Males or females; females of childbearing age who are not currently pregnant must agree to use a medically accepted method of contraception throughout the study.
Age greater than or equal to 25 years.
Patients must be on a maximum dose of dopamine agonist drug (pergolide 4mg/day, pramipexole 4.5 mg/day or ropinirole 24mg/day).
Stable dose of all medications for 4 weeks.
Exclusion Criteria:
Current hallucinations.
History of disabling hallucinations or hallucinations in past requiring treatment.
Troublesome edema (swelling).
Unstable depression.
Female who is pregnant or lactating.
Use of an investigational drug with in the last 30 days.
Other inclusion or exclusion criteria to be evaluated by the physician.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Deborah Judd, RN, CCRC
Phone
303-762-6667
Email
judd@megapathdsl.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pinky Agarwal, MD
Organizational Affiliation
Colorado Neurology, P.C.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Colorado Neurology, P.C.
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deborah Judd, RN, CCRC
Phone
303-762-6667
Email
judd@megapathdsl.net
First Name & Middle Initial & Last Name & Degree
Pinky Agarwal, MD
12. IPD Sharing Statement
Learn more about this trial
Open Label High Dose Ropinirole (Requip) Study for Patients With Parkinson's Disease
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