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

Sponsor

The Parkinson's Institute (Other)

Overall Status

Unknown status

CT.gov ID

NCT01007630

Collaborator

Teva Neuroscience, Inc. (Industry)

Enrollment

Location

Arms

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson's Disease	Drug: Rasagiline Drug: Placebo	Phase 4

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

Nov 1, 2009

Anticipated Primary Completion Date :

Jan 1, 2014

Anticipated Study Completion Date :

Jan 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Rasagiline 0.5mg of Rasagiline for 14 days, then switch to 1mg of Rasagiline for remainder of the study (approximately 10 weeks total).	Drug: Rasagiline 0.5mg for 14 days, then switch to 1mg for remainder of the study (approximately 10 weeks total) Other Names: Brand Name: Azilect
Placebo Comparator: Placebo 0.5mg of placebo for 14 days, then switch to 1mg of placebo for remainder of the study (approximately 10 weeks total)	Drug: Placebo 0.5mg for 14 days, then switch to 1mg for remainder of the study (approximately 10 weeks total)

Arm

Intervention/Treatment

Active Comparator: Rasagiline

0.5mg of Rasagiline for 14 days, then switch to 1mg of Rasagiline for remainder of the study (approximately 10 weeks total).

Drug: Rasagiline

0.5mg for 14 days, then switch to 1mg for remainder of the study (approximately 10 weeks total)

Other Names:

Brand Name: Azilect

Placebo Comparator: Placebo

0.5mg of placebo for 14 days, then switch to 1mg of placebo for remainder of the study (approximately 10 weeks total)

Drug: Placebo

0.5mg for 14 days, then switch to 1mg for remainder of the study (approximately 10 weeks total)

Outcome Measures

Primary Outcome Measures

Change from baseline in UPSIT score at 10-week visit [10 weeks]

Secondary Outcome Measures

Tolerability: Number of subjects (%) who discontinue the study due to AEs [10 weeks]
Safety: AE incidence [10 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)