Efficacy of Orally Disintegrating Selegiline in Parkinson's Patients Experiencing Adverse Effects With Dopamine Agonists

Completed · Phase 4

Conditions studied: Parkinson's Disease

In brief

The purpose of the study is to determine if reducing or eliminating a dopamine agonist (DA) causing one of the side effects of daytime sleepiness, swelling of the lower legs or feet, hallucinations or impulsive behaviors while adding orally disintegrating selegiline can eliminate the adverse effect and maintain control of Parkinson's disease (PD) symptoms.

Key facts

Study ID

NCT00443872

Run by

Parkinson's Disease and Movement Disorder Center of Boca Raton

People needed

77

Starts

2007-03-01

Expected to finish

2008-12-01

Last updated by the study team

2014-10-31

Who can join

Age: 30 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Idiopathic Parkinson's disease (PD) confirmed by at least two of the following signs: resting tremor, bradykinesia,rigidity
• Male or female outpatients
• Age 30-90 years
• Current use of levodopa (stable for at least 1 month) and a dopamine agonist (pramipexole or ropinirole)
• Treatment response to current anti-parkinsonian medications in the opinion of the investigator
• Dopamine agonist adverse effect that in the opinion of the investigator requires a reduction or discontinuation of the dopamine agonist. The adverse effects must be in one of the following four categories and should not be so severe as to require immediate discontinuation of the dopamine agonist (i.e., hallucinations without insight, serious impulsive behavior resulting in significant loss or danger to the patient).
• Daytime sleepiness - must score >10 on Epworth Sleepiness Scale (ESS) at Baseline; Pedal edema - bothersome/concerning to patient; Hallucinations - insight should be maintained; Impulsive behavior - not including behaviors that are harmful to the patient requiring immediate discontinuation of the agonist.
• Daily off time
• Acceptable contraception for females of child bearing potential
• Willing and able to comply with study procedures.
• Willing and able to give written informed consent prior to beginning any study procedures.

You may not qualify if…

• Atypical parkinsonism due to drugs, metabolic disorders, encephalitis, trauma, or other neurodegenerative diseases.
• Significant cognitive or psychiatric impairment which, in the opinion of the investigator, would interfere with the ability to complete all the tests required in the protocol.
• Participation in another clinical drug trial within the previous four weeks.
• Patients currently on monoamine oxidase type A or B (MAO-A or B) inhibitors, meperidine, tramadol, methadone, propoxyphene, dextromethorphan, and mirtazapine.
• History of hypersensitivity or adverse reaction to selegiline or previous exposure to orally disintegrating selegiline
• History of melanoma
• Unstable/uncontrolled medical problems
• History of drug/alcohol abuse

Where it is running

• University of California - Irvine — Irvine, California, United States
• Coastal Neurological Medical Group, Inc — La Jolla, California, United States
• University of Southern California — Los Angeles, California, United States
• The Parkinson's Institute — Sunnyvale, California, United States
• Parkinson's Disease and Movement Disorder Center of Boca Raton — Boca Raton, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Methodist Plaza Speciality Clinic — Des Moines, Iowa, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Harvard Vanguard Medical Associates — Boston, Massachusetts, United States
• Henry Ford Health Center - Franklin Pointe — Southfield, Michigan, United States
• Struthers Parkinson's Center — Golden Valley, Minnesota, United States
• University of Toledo — Toledo, Ohio, United States
• NeuroHealth Parkinson Disease and Movement Disorder Center — Warwick, Rhode Island, United States
• Neurology Specialists Dallas — Dallas, Texas, United States
• ETMC Neurological Institute — Tyler, Texas, United States

Full record on ClinicalTrials.gov

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