CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 77 enrolled
Drug / intervention
orally disintegrating selegiline (Zelapar)drug
Likely dose
orally disintegrating selegiline (Zelapar) 1.25 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00443872
NCT00443872Phase 4Completed
CompareCT.gov

Adding Orally Disintegrating Selegiline (Zelapar) to Patients Taking Dopamine Agonists and Experiencing Complications

Parkinson's Disease and Movement Disorder Center of Boca Raton·interventional·Posted Mar 6, 2007·Updated Oct 31, 2014

In Brief

A Phase 4 clinical trial evaluating orally disintegrating selegiline (Zelapar) for Parkinson's Disease. Completed, enrolled 77 participants across 17 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson's Disease
CountriesUnited States
CollaboratorsBausch Health Americas, Inc.

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 6, 2007
Enrollment StartMar 1, 2007
Primary CompletionSep 1, 2008
Study CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 19.3 years ago

Interventions

orally disintegrating selegiline (Zelapar)drug

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