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

Information source: Colorado Neurology
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Parkinson's Disease

Intervention: Ropinirole Hydrochloride (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Agarwal, Pinky, M.D.

Official(s) and/or principal investigator(s):
Pinky Agarwal, MD, Principal Investigator, Affiliation: Colorado Neurology, P.C.

Overall contact:
Deborah Judd, RN, CCRC, Phone: 303-762-6667, Email: judd@megapathdsl.net

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.

Clinical Details

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

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

Eligibility

Minimum age: 25 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Deborah Judd, RN, CCRC, Phone: 303-762-6667, Email: judd@megapathdsl.net

Colorado Neurology, P.C., Englewood, Colorado 80113, United States; Recruiting
Deborah Judd, RN, CCRC, Phone: 303-762-6667, Email: judd@megapathdsl.net
Pinky Agarwal, MD, Principal Investigator
Additional Information

Starting date: November 2005
Last updated: February 2, 2006

Page last updated: August 23, 2015

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