Status:
COMPLETED
Selegiline to Zelapar Switch Study in Parkinson Disease Patients
Lead Sponsor:
Baylor College of Medicine
Conditions:
Parkinson's Disease
Eligibility:
All Genders
30-90 years
Phase:
PHASE4
Brief Summary
Parkinson's disease (PD) is a progressive neurodegenerative disease. Symptomatic therapy is primarily aimed at restoring dopamine function in the brain. Oral selegiline in conjunction with L-dopa has ...
Detailed Description
This is an open label, multicenter, 6 week study of the conversion from oral selegiline to orally disintegrating selegiline in PD patients with or without motor fluctuations, and currently taking levo...
Eligibility Criteria
Inclusion
- Idiopathic 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 and oral selegiline (5-10 mg /day), stable for at least 1 month and well tolerated
- Positive treatment response to current anti-parkinsonian medications in the opinion of the investigator
- 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.
Exclusion
- 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 on any medications contraindicated with Zelapar (including meperidine/Demerol, tramadol, methadone, propoxyphene, dextromethorphan, other selegiline products)
- Patients with a known hypersensitivity to any formulation of selegiline or any of the inactive ingredients of Zelapar, or previous exposure to orally disintegrating selegiline
- History of melanoma
- Unstable/uncontrolled medical problems
- History of drug/alcohol abuse
- Patients currently taking rasagiline
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00640159
Start Date
January 1 2007
End Date
August 1 2008
Last Update
August 9 2023
Active Locations (5)
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1
Dee Silver, MD at Coastal Neurological Medical Group, Inc
La Jolla, California, United States, 92037
2
James Tetrud, MD at The Parkinson's Institute
Sunnyvale, California, United States, 94085
3
Stuart Isaacson, MD at Parkinson's Disease and Movement Disorder Center of Boca Raton
Boca Raton, Florida, United States, 33486
4
R. Malcolm Stewart, MD at Neurology Specialists of Dallas
Dallas, Texas, United States, 75231