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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
History of Changes
  Purpose

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 Intervention Phase
Parkinson's Disease
 Drug: Ropinirole Hydrochloride
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Colorado Neurology:

Estimated Enrollment: 20
Study Start Date: November 2005
  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00260793     History of Changes
Other Study ID Numbers: 103911
Study First Received: December 1, 2005
Last Updated: February 2, 2006
Health Authority: United States: Institutional Review Board

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
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013