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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.
ClinicalTrials.gov 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
Sponsor:
Collaborators:
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: Ropinirole Hydrochloride Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label Prospective Study of High Dose Ropinirole for Motor Fluctuations and Dyskinesias in Advanced Parkinson's Disease
Study Start Date : November 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00260793


Contacts
Contact: Deborah Judd, RN, CCRC 303-762-6667 judd@megapathdsl.net

Locations
United States, Colorado
Colorado Neurology, P.C. Recruiting
Englewood, Colorado, United States, 80113
Contact: Deborah Judd, RN, CCRC    303-762-6667    judd@megapathdsl.net   
Principal Investigator: Pinky Agarwal, MD         
Sponsors and Collaborators
Agarwal, Pinky, M.D.
Colorado Neurology
GlaxoSmithKline
Investigators
Principal Investigator: Pinky Agarwal, MD Colorado Neurology, P.C.
More Information

ClinicalTrials.gov Identifier: NCT00260793     History of Changes
Other Study ID Numbers: 103911
First Posted: December 2, 2005    Key Record Dates
Last Update Posted: February 3, 2006
Last Verified: November 2005

Keywords provided by Colorado Neurology:
Ropinirole
Parkinson's disease
dopamine agonist

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Ropinirole
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs