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Official Study Title: A Prospective Randomized Placebo-Controlled Double-Blind  Double-blindClinical study design in which neither investigators nor participants know who is receiving the investigational drug and who is receiving a placebo. Study Assessing Change in Olfactory Function After Initiation of Rasagiline in Idiopathic  IdiopathicOf, relating to, or designating a disease having no known cause. Parkinson's Disease
Sponsor: Teva Neuroscience, Inc.
Clinicaltrials.gov ID: PD-SOAR
Study ID: NCT01007630

Summary

A decrease or loss of the sense of smell is very common in patients with Parkinson's disease  Parkinson's DiseaseA chronic, slowly progressive disease of the nervous system characterized by the combination of tremor, rigidity, bradykinesia and stooped posture, among other symptoms. (PD) 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 PD.

Rasagiline (brand name: Azilect) was approved by the U.S. Food and Drug Administration  Food and Drug AdministrationThe U.S. Department of Health and Human Services is the agency responsible for ensuring the safety and effectiveness  EffectivenessAbility of a drug or treatment to produce a result. of all drugs, biologics, vaccines, and medical devices. Internet address: http://www.fda.gov. in 2006 to be used by people with Parkinson's to treat the motor symptoms  Motor SymptomsThe physical symptoms of PD, such as balance, rigidity, tremor, freeze attacks, involuntary movements (dyskinesia), slowness of movement (bradykinesia), walking/gait, postural difficulties*, writing difficulty, swallowing difficulty* (dysphagia), muscle pain*, masked face*, speech problems* and general loss of motor skills. associated with the disease. The purpose of this study is to see if there is change in sense of smell after starting Rasagiline.

Study Phase

Phase 4
What is a study phase?

Symptoms Addressed: Non-movement Symptoms

Diminished sense of smell

Time Commitment

• Less than six months
• Two visits (day 1 and week 10), one phone call (day 14)

Eligibility

• Minimum Age: 30
• Maximum Age: 90
• Gender(s) Accepted: Either

Inclusion Criteria

• Men and women with Parkinson’s disease, defined as the presence of at least two of the cardinal signs of PD (bradykinesia,  BradykinesiaSlowness of movement. resting tremor,  Resting TremorA tremor of a limb that increases when the limb is at rest. rigidity)  RigidityA symptom in which muscles feel stiff and display resistance to movement even when another person tries to move the affected part of the body. without other identifiable cause of parkinsonism or signs of atypical parkinsonism
• Decreased sense of smell
• Have been on stable dose of PD medications for at least 30 days
• 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  ScreeningPeriod of selection of clinical trial participants based on ELIGIBILITY CRITERIA. visit and be non-lactating

Exclusion Criteria

• Prior use of an MAO inhibitor, including selegiline  SelegilineInhibitor that increases the amount of dopamine in the brain to help control the symptoms of Parkinson's in people who are taking levodopa and carbidopa in combination (Sinemet). Selegiline may help people with Parkinson's to decrease the dose of levodopa/carbidopa needed to control symptoms, stopping the effects of levodopa/carbidopa from wearing off between doses, and increasing the length of time that levodopa/carbidopa will continue to control symptoms. or rasagiline, within the 12 months prior to first study visit
• Presence of other conditions that 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  DementiaA decline in higher-level brain functions, such as memory, reasoning and personality. or significant cognitive  CognitiveRelated to mental activities having to do with perception, memory, judgment, and reasoning. impairment
• Use of any experimental medication within 60 days of first study visit
• Use of decongestants, antihistamines, inhaled steroids within two weeks of first study visit
• Use of any medication contraindicated with use of rasagiline

Enrollment

Expected Enrollment: 40 (US)
Date Enrollment Began: Nov 2009
Date Enrollment Ends:
Last Updated Date: Aug 19 2010
Trial Post Date: Jun 18 2010
Website: http://clinicaltrials.gov/ct2/show/NCT01007630?term=pd-soar&rank=1

Primary Contacts and Locations

California

• Liza Reys — Clinical  ClinicalDealing with or based on observation and treatment of people, as opposed to basic science carried out in the laboratory or in animals. Research Coordinator
  The Parkinson's Institute
  lreys@thepi.org
  Phone: (408) 542-5626
  675 Almanor Ave.
  Sunnyvale, CA 94085
  USA