A Study Assessing Change in Sense of Smell After Rasagiline Use in Parkinson's Patients

NCT01007630 | Unknown Phase 4

• 1 other identifier: PD-SOAR
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease

Keywords

Parkinson's; Parkinsons; Parkinson; Parkinson's Disease; PD; Rasagiline; Azilect; Olfactory; Sense of Smell; UPSIT

Outcome Measures

Primary Outcomes (1)

• Change from baseline in UPSIT score at 10-week visit

  10 weeks

Secondary Outcomes (2)

• Tolerability: Number of subjects (%) who discontinue the study due to AEs

  10 weeks

• Safety: AE incidence

  10 weeks

Study Arms (2)

Rasagiline

ACTIVE COMPARATOR

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

Drug: Rasagiline

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Rasagiline DRUG

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

Also known as: Brand Name: Azilect

Rasagiline

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: Up to 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Parkinson's Institute: lead
• Teva Neuroscience, Inc.: collaborator

Study Sites (1)

The Parkinson's Institute

Sunnyvale, California, 94085, United States

Location

Related Links

• The Parkinson's Institute Clinical Trials Website

MeSH Terms

Conditions

Parkinson Disease; Anosmia

Interventions

rasagiline

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Olfaction Disorders; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Grace S Liang, MD

  The Parkinson's Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Director of Clinical Trials

Study Record Dates

• First Submitted: November 3, 2009
• First Posted: November 4, 2009
• Study Start: November 1, 2009
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: December 2, 2013

Record last verified: 2013-11

Locations

US (1)