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

This study is currently recruiting participants.

Verified by Colorado Neurology, November 2005

First Received: December 1, 2005 Last Updated: February 2, 2006 History of Changes

Sponsor:	Agarwal, Pinky, M.D.
Collaborators:	Colorado Neurology GlaxoSmithKline
Information provided by:	Colorado Neurology
ClinicalTrials.gov Identifier:	NCT00260793

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 III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
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:

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Ropinirole hydrochloride Ropinirole

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

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

Keywords provided by Colorado Neurology:

Ropinirole
Parkinson's disease
dopamine agonist

Additional relevant MeSH terms:

Neurotransmitter Agents
Ropinirole
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Basal Ganglia Diseases
Nervous System Diseases
Central Nervous System Diseases
Antiparkinson Agents
Dopamine Agonists

Brain Diseases
Neurodegenerative Diseases
Pharmacologic Actions
Parkinson Disease
Movement Disorders
Therapeutic Uses
Dopamine Agents
Parkinsonian Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009