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A Prospective Randomized Placebo-Controlled Double-Blind Study Assessing Change in Olfactory Function After Initiation of Rasagiline in Idiopathic Parkinson's Disease
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.
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
Age
0 - 90 years
Sex
ALL
Healthy Volunteers
No
The Parkinson's Institute
Sunnyvale, California, United States
Start Date
November 1, 2009
Primary Completion Date
January 1, 2014
Completion Date
January 1, 2014
Last Updated
December 2, 2013
36
ESTIMATED participants
Rasagiline
DRUG
Placebo
DRUG
Lead Sponsor
The Parkinson's Institute
Collaborators
NCT07310264
NCT02119611
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07216976