Back to resultsA Study Assessing Change in Sense of Smell After Rasagiline Use in Parkinson's Patients (PD-SOAR)
Primary Purpose
Parkinson's Disease
Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Rasagiline
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's, Parkinsons, Parkinson, Parkinson's Disease, PD, Rasagiline, Azilect, Olfactory, Sense of Smell, UPSIT
Eligibility Criteria
Inclusion Criteria:
- Men and women with Parkinson's Disease (PD), defined as the presence of at least two of the cardinal signs of PD (bradykinesia, resting tremor, rigidity) without other identifiable cause of parkinsonism or signs of atypical parkinsonism
- Functional hyposmia or anosmia, as defined by UPSIT scores less than the 25th percentile for age- and gender-matched norms
- Have been on stable dose of PD medications for at least 30 days
- Age < or = 90 years
- Willing and able to give informed consent
- Women of child-bearing potential may participate provided they are willing to use adequate contraceptive methods during the duration of the study. Women of childbearing potential must have a negative pregnancy test at the screening visit and be non-lactating.
Exclusion Criteria:
- Prior use of an MAO inhibitor, including selegiline or rasagiline within the last 12 months
- Presence of other conditions that in the investigator's opinion may significantly cause olfactory impairment, including prior head trauma, nasal surgery, nasal inflammation causing concurrent congestion or polyps, nasal or sinus infection, prior intranasal zinc salt (Zicam) use, history of smoking within the past year
- Presence of dementia or significant cognitive impairment with Mini-Mental State Examination (MMSE) < 24
- Present of a medical or surgical condition which in the opinion of the investigator would preclude participation in and completion of study procedures
- Use of any experimental medication within 60 days of baseline
- Use of decongestants, antihistamines, inhaled steroids within 2 weeks of baseline
- Use of any medication contraindicated with use of rasagiline (Investigator will take into consideration concomitant antidepressant use as per prescribing information guidelines for rasagiline)
Sites / Locations
- The Parkinson's Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Rasagiline
Placebo
Arm Description
0.5mg of Rasagiline for 14 days, then switch to 1mg of Rasagiline for remainder of the study (approximately 10 weeks total).
0.5mg of placebo for 14 days, then switch to 1mg of placebo for remainder of the study (approximately 10 weeks total)
Outcomes
Primary Outcome Measures
Change from baseline in UPSIT score at 10-week visit
Secondary Outcome Measures
Tolerability: Number of subjects (%) who discontinue the study due to AEs
Safety: AE incidence
Full Information
NCT ID
NCT01007630
First Posted
November 3, 2009
Last Updated
November 27, 2013
Sponsor
The Parkinson's Institute
Collaborators
Teva Neuroscience, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01007630
Brief Title
A Study Assessing Change in Sense of Smell After Rasagiline Use in Parkinson's Patients
Acronym
PD-SOAR
Official Title
A Prospective Randomized Placebo-Controlled Double-Blind Study Assessing Change in Olfactory Function After Initiation of Rasagiline in Idiopathic Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Unknown status
Study Start Date
November 2009 (undefined)
Primary Completion Date
January 2014 (Anticipated)
Study Completion Date
January 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Parkinson's Institute
Collaborators
Teva Neuroscience, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's, Parkinsons, Parkinson, Parkinson's Disease, PD, Rasagiline, Azilect, Olfactory, Sense of Smell, UPSIT
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Rasagiline
Arm Type
Active Comparator
Arm Description
0.5mg of Rasagiline for 14 days, then switch to 1mg of Rasagiline for remainder of the study (approximately 10 weeks total).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
0.5mg of placebo for 14 days, then switch to 1mg of placebo for remainder of the study (approximately 10 weeks total)
Intervention Type
Drug
Intervention Name(s)
Rasagiline
Other Intervention Name(s)
Brand Name: Azilect
Intervention Description
0.5mg for 14 days, then switch to 1mg for remainder of the study (approximately 10 weeks total)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
0.5mg for 14 days, then switch to 1mg for remainder of the study (approximately 10 weeks total)
Primary Outcome Measure Information:
Title
Change from baseline in UPSIT score at 10-week visit
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Tolerability: Number of subjects (%) who discontinue the study due to AEs
Time Frame
10 weeks
Title
Safety: AE incidence
Time Frame
10 weeks
10. Eligibility
Sex
All
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men and women with Parkinson's Disease (PD), defined as the presence of at least two of the cardinal signs of PD (bradykinesia, resting tremor, rigidity) without other identifiable cause of parkinsonism or signs of atypical parkinsonism
Functional hyposmia or anosmia, as defined by UPSIT scores less than the 25th percentile for age- and gender-matched norms
Have been on stable dose of PD medications for at least 30 days
Age < or = 90 years
Willing and able to give informed consent
Women of child-bearing potential may participate provided they are willing to use adequate contraceptive methods during the duration of the study. Women of childbearing potential must have a negative pregnancy test at the screening visit and be non-lactating.
Exclusion Criteria:
Prior use of an MAO inhibitor, including selegiline or rasagiline within the last 12 months
Presence of other conditions that in the investigator's opinion may significantly cause olfactory impairment, including prior head trauma, nasal surgery, nasal inflammation causing concurrent congestion or polyps, nasal or sinus infection, prior intranasal zinc salt (Zicam) use, history of smoking within the past year
Presence of dementia or significant cognitive impairment with Mini-Mental State Examination (MMSE) < 24
Present of a medical or surgical condition which in the opinion of the investigator would preclude participation in and completion of study procedures
Use of any experimental medication within 60 days of baseline
Use of decongestants, antihistamines, inhaled steroids within 2 weeks of baseline
Use of any medication contraindicated with use of rasagiline (Investigator will take into consideration concomitant antidepressant use as per prescribing information guidelines for rasagiline)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grace S Liang, MD
Organizational Affiliation
The Parkinson's Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Parkinson's Institute
City
Sunnyvale
State/Province
California
ZIP/Postal Code
94085
Country
United States
12. IPD Sharing Statement
Links:
URL
http://thepi.org/index.php?submenu=clinical_trials&src=gendocs&ref=ClinicalTrialsMain&category=clinical_trials
Description
The Parkinson's Institute Clinical Trials Website
Learn more about this trial
A Study Assessing Change in Sense of Smell After Rasagiline Use in Parkinson's Patients
We'll reach out to this number within 24 hrs