Efficacy of Orally Disintegrating Selegiline in Parkinson's Patients Experiencing Adverse Effects With Dopamine Agonists
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      Parkinson's disease (PD) is a progressive neurodegenerative disease. Symptomatic therapy is
      primarily aimed at restoring dopamine function in the brain. Levodopa is the most effective
      symptomatic treatment; however, long term use is associated with motor fluctuations (periods
      of return of PD symptoms when medication effect wears off) and dyskinesia (drug induced
      involuntary movements including chorea and dystonia). Once patients develop motor
      fluctuations treatment options include increasing the frequency of levodopa dosing, switching
      to sustained-release levodopa, adding other therapies including monoamine oxidase type B
      (MAO-B) inhibitors, dopamine agonists, catechol-o-methyltransferase (COMT) inhibitors and in
      patients with severe motor fluctuations deep brain stimulation surgery. There are no good
      evidence based studies indicating whether the use of one of these class of drugs is superior
      to the other nor are there treatment algorithms that recommend which class of drug should be
      initiated when the patients initially develop motor fluctuations. It is believed that the
      efficacy of the different drug classes is similar. However, the frequency of adverse effects
      may differ between drug classes, but such studies are lacking. In clinical practice when
      patients develop adverse effects to a drug from one class, a drug from another class is
      substituted in an attempt to maintain efficacy with reduced adverse effects.

      Dopamine agonists often have a higher risk of adverse effects compared to MAO B inhibitors.
      Therefore, the rationale for this study is that the addition of orally disintegrating
      selegiline after the reduction or discontinuation of the offending dopamine agonist will
      result in comparable efficacy with reduced adverse events. This study will assess the safety
      and efficacy of the addition of orally disintegrating selegiline in PD patients who are
      having adverse effects to dopamine agonists for which a dose reduction of the dopamine
      agonist is being considered. All patients in the study will receive orally disintegrating
      selegiline 1.25 mg once a day and the dose will be increased to 2.5 mg once a day if
      tolerated.

      Comparisons: The status of the adverse event at the end of the study while on orally
      disintegrating selegiline will be compared to the adverse event at the start of the study. In
      addition, efficacy will be compared at the start of the study while on the dopamine agonist
      to the end of the study with orally disintegrating selegiline.
    

Intervention name(s): orally disintegrating selegiline (Zelapar)
Intervention type(s): Drug
Intervention description(s): 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
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Parkinson's disease; Dopamine agonist adverse effects; MAO-B inhibitor; orally disintegrating selegiline; Zelapar