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

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.

Timeline

Start

2007-03

Primary completion

2008-09

Completion

2008-12

Outcome

Met primary endpoint

registry analysis (superiority or other test); PD Patients With DA Related AE (Daytime Sleepiness); p <0.01; Mean Difference (Final Values) 4.5; Wilcoxon (Mann-Whitney) NCT00443872 ↗

registry analysis (superiority or other test); PD Patients With DA Related AE (Hallucinations); p <0.01; Mean Difference (Final Values) 2.0; Wilcoxon (Mann-Whitney) NCT00443872 ↗

registry analysis (superiority or other test); PD Patiens With DA Related AE (Pedal Edema); p <0.01; Mean Difference (Final Values) 1.2; t-test, 2 sided NCT00443872 ↗

registry analysis (superiority or other test); PD Patients With DA Related AE (Impulse Control Disorder); p <0.05; Mean Difference (Final Values) 2.8; Wilcoxon (Mann-Whitney) NCT00443872 ↗

Publications

• Results Lyons KE, Friedman JH, Hermanowicz N, Isaacson SH, Hauser RA, Hersh BP, Silver DE, Tetrud JW, Elmer LW, Parashos SA, Struck LK, Lew MF, Pahwa R. Orally disintegrating selegiline in Parkinson patients with dopamine agonist-related adverse effects. Clin Neuropharmacol. 2010 Jan-Feb;33(1):5-10. doi: 10.1097/WNF.0b013e3181b7926f.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Selegiline	Unknown	2.5 mg	Oral

Indications