Open Label High Dose Ropinirole (Requip) Study for Patients With Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00260793
Recruitment Status : Unknown
Verified November 2005 by Colorado Neurology.
Recruitment status was:  Recruiting
First Posted : December 2, 2005
Last Update Posted : February 3, 2006
Colorado Neurology
Information provided by:
Colorado Neurology

December 1, 2005
December 2, 2005
February 3, 2006
November 2005
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Complete list of historical versions of study NCT00260793 on Archive Site
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Open Label High Dose Ropinirole (Requip) Study for Patients With Parkinson's Disease
Open Label Prospective Study of High Dose Ropinirole for Motor Fluctuations and Dyskinesias in Advanced Parkinson's Disease
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.
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Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Parkinson's Disease
Drug: Ropinirole Hydrochloride
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
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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.
Sexes Eligible for Study: All
25 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Agarwal, Pinky, M.D.
  • Colorado Neurology
  • GlaxoSmithKline
Principal Investigator: Pinky Agarwal, MD Colorado Neurology, P.C.
Colorado Neurology
November 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP