Efficacy of Orally Disintegrating Selegiline in Parkinson's Patients Experiencing Adverse Effects With Dopamine Agonists
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: orally disintegrating selegiline (Zelapar)
Intervention description: 1.25 mg once daily orally disintegrating selegiline for 6 weeks with an increase to 2.5 mg once daily orally disintegrating selegiline for remaining 6 weeks if tolerated
Intervention MeSH terms: Selegiline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 77.0
Sex: All
Minimum age: 30 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Parkinson's disease; Dopamine agonist adverse effects; MAO-B inhibitor; orally disintegrating selegiline; Zelapar

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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.

        Exclusion Criteria:

          -  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