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

Parkinson's Disease Clinical Trial

Official title:

Open Label Prospective Study of High Dose Ropinirole for Motor Fluctuations and Dyskinesias in Advanced Parkinson's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00260793
• Other study ID #: 103911
• Status: Recruiting
• Phase: Phase 3
• First received: December 1, 2005
• Last updated: February 2, 2006
• Start date: November 2005

Study information

• Verified date: November 2005
• Source: Colorado Neurology
• Contact: Deborah Judd, RN, CCRC
• Phone: 303-762-6667
• Email: judd[@]megapathdsl.net
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• Ropinirole Hydrochloride

Locations

Country	Name	City	State
United States	Colorado Neurology, P.C.	Englewood	Colorado

Sponsors (3)

Lead Sponsor	Collaborator
Agarwal, Pinky, M.D.	Colorado Neurology, GlaxoSmithKline

Country where clinical trial is conducted

United States,