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

February 2, 2006 updated by: Agarwal, Pinky, M.D.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

20

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Colorado
      • Englewood, Colorado, United States, 80113
        • Recruiting
        • Colorado Neurology, P.C.
        • Contact:
        • Principal Investigator:
          • Pinky Agarwal, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Agarwal, Pinky, M.D.

Collaborators

GlaxoSmithKline
Colorado Neurology

Investigators

  • Principal Investigator: Pinky Agarwal, MD, Colorado Neurology, P.C.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Study Registration Dates

First Submitted

December 1, 2005

First Submitted That Met QC Criteria

December 1, 2005

First Posted (Estimate)

December 2, 2005

Study Record Updates

Last Update Posted (Estimate)

February 3, 2006

Last Update Submitted That Met QC Criteria

February 2, 2006

Last Verified

November 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 103911

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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