Recruiting
Phase 3

Requip

Sponsor:

Agarwal, Pinky, M.D.

Code:

NCT00260793

Conditions

Parkinson's Disease

Eligibility Criteria

Sex: All

Age: 25+

Healthy Volunteers: Not accepted

Interventions

Ropinirole Hydrochloride

Study Details

Brief 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.

Conditions

Parkinson's Disease

Study ID

NCT00260793

Start date

Nov, 2005

Status verified date

Nov, 2005

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25+

Healthy Volunteers: Not accepted

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

Enrollment

20 participants

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Ropinirole Hydrochloride

Central Contacts and Locations

Central contacts

Deborah Judd, RN, CCRC

303-762-6667judd@megapathdsl.net

Locations

Colorado Neurology, P.C.

Recruiting

Englewood, Colorado, United States, 80113

Contacts

Deborah Judd, RN, CCRC

303-762-6667judd@megapathdsl.net

Principal Investigator:

Pinky Agarwal, MD

More Information

Sponsor

Agarwal, Pinky, M.D.

Last update posted

Feb 3, 2006

Last verified

Nov, 2005

Keywords

  • Ropinirole
  • Parkinson's disease
  • dopamine agonist

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Agarwal, Pinky, M.D. on 2006-02-03.