A Study Assessing Change in Sense of Smell After Rasagiline Use in Parkinson's Patients — PD-SOAR  

Parkinson's Disease Clinical Trial

Official title: A Prospective Randomized Placebo-Controlled Double-Blind Study Assessing Change in Olfactory Function After Initiation of Rasagiline in Idiopathic Parkinson's Disease

Status Active, not recruiting

Clinical Trial Summary

A decrease or loss of the sense of smell is very common in patients with Parkinson's Disease even in the earliest stages of the disease. There have been no treatments that have been proven to improve sense of smell in patients with Parkinson's Disease.

Rasagiline (brand name: Azilect) was approved by the U.S. Food and Drug Administration (FDA) on May 16th 2006 to be used by Parkinson's patients to treat the motor symptoms associated with the disease. The purpose of this study is to see if there is change in sense of smell after starting Rasagiline.

Clinical Trial Description

This study will last approximately 10 weeks.

• 2 visits to The Parkinson's Institute in Sunnyvale, California

• 1 phone call between visits

You will be asked to take either Rasagiline (Azilect) or placebo (an identical pill without active ingredients)

• 5 in 6 chance of receiving Rasagiline (Azilect)

• 1 in 6 chance of receiving placebo

• Neither you nor the study team will know which you are assigned

• This information will be available in case of emergency

To be eligible for this study, you must:

• be 90 years old or younger

• have a decreased loss of smell or complete loss of smell

• have not taken Selegiline or Rasagiline within the past 12 months

• have not smoked within the last year

• be on a stable dose of Parkinson's medication (or not on any PD medicines)

• have no history of head trauma, nasal surgery, nasal inflammation causing congestion or polyps, nasal/sinus infection, or prior Zicam use

• have not used decongestants, antihistamine or inhaled steroids within 2 weeks of the study and be willing to avoid such treatments during the study ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

• NCT number: NCT01007630
• Study type: Interventional
• Source: The Parkinson's Institute
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: November 2009
• Completion date: January 2014