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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2005 by Colorado Neurology.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Colorado Neurology
GlaxoSmithKline
Information provided by:
Colorado Neurology
ClinicalTrials.gov Identifier:
NCT00260793
First received: December 1, 2005
Last updated: February 2, 2006
Last verified: November 2005

December 1, 2005
February 2, 2006
November 2005
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Complete list of historical versions of study NCT00260793 on ClinicalTrials.gov 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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Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
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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.
Both
25 Years and older
No
Contact: Deborah Judd, RN, CCRC 303-762-6667 judd@megapathdsl.net
United States
 
NCT00260793
103911
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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