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

NCT ID: NCT00260793

Last Updated: 2006-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Parkinson's Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Ropinirole Hydrochloride

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Colorado Neurology

OTHER

Sponsor Role collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

Agarwal, Pinky, M.D.

INDIV

Sponsor Role lead

Principal Investigators

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Pinky Agarwal, MD

Role: PRINCIPAL_INVESTIGATOR

Colorado Neurology, P.C.

Locations

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Colorado Neurology, P.C.

Englewood, Colorado, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Deborah Judd, RN, CCRC

Role: CONTACT

303-762-6667

Facility Contacts

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Deborah Judd, RN, CCRC

Role: primary

303-762-6667

Other Identifiers

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103911

Identifier Type: -

Identifier Source: org_study_id