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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Teva Neuroscience, Inc.
Information provided by (Responsible Party):
Grace Liang, The Parkinson's Institute
ClinicalTrials.gov Identifier:
NCT01007630
First received: November 3, 2009
Last updated: November 27, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Parkinson's Disease
Drug: Rasagiline
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by The Parkinson's Institute:

Primary Outcome Measures:
  • Change from baseline in UPSIT score at 10-week visit [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tolerability: Number of subjects (%) who discontinue the study due to AEs [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • Safety: AE incidence [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 36
Study Start Date: November 2009
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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)

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
  Eligibility

Ages Eligible for Study:   up to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01007630

Locations
United States, California
The Parkinson's Institute
Sunnyvale, California, United States, 94085
Sponsors and Collaborators
The Parkinson's Institute
Teva Neuroscience, Inc.
Investigators
Principal Investigator: Grace S Liang, MD The Parkinson's Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Grace Liang, Principal Investigator, Director of Clinical Trials, The Parkinson's Institute
ClinicalTrials.gov Identifier: NCT01007630     History of Changes
Other Study ID Numbers: PD-SOAR
Study First Received: November 3, 2009
Last Updated: November 27, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by The Parkinson's Institute:
Parkinson's
Parkinsons
Parkinson
Parkinson's Disease
PD
Rasagiline
Azilect
Olfactory
Sense of Smell
UPSIT

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Rasagiline
Monoamine Oxidase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014