Full Text View
Tabular View
No Study Results Posted
Related Studies
Open Label High Dose Ropinirole (Requip) Study for Patients With Parkinson's Disease
This study is currently recruiting participants.
Study NCT00260793   Information provided by Colorado Neurology
First Received: December 1, 2005   Last Updated: February 2, 2006   History of Changes

December 1, 2005
February 2, 2006
November 2005
 
 
 
Complete list of historical versions of study NCT00260793 on ClinicalTrials.gov Archive Site
 
 
 
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.

 
Phase III
Interventional
Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Parkinson's Disease
Drug: Ropinirole Hydrochloride
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
20
 
 

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
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