Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Teva Neuroscience, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
This study will last approximately 10 weeks.
You will be asked to take either Rasagiline (Azilect) or placebo (an identical pill without active ingredients)
To be eligible for this study, you must:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rasagiline | Drug | 0.5mg for 14 days, then switch to 1mg for remainder of the study (approximately 10 weeks total) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in UPSIT score at 10-week visit | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability: Number of subjects (%) who discontinue the study due to AEs | 10 weeks | |
| Safety: AE incidence | 10 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Grace S Liang, MD | The Parkinson's Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Parkinson's Institute | Sunnyvale | California | 94085 | United States |
Not provided
| Label | URL |
|---|---|
| The Parkinson's Institute Clinical Trials Website | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D000086582 | Anosmia |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C031967 | rasagiline |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | 0.5mg for 14 days, then switch to 1mg for remainder of the study (approximately 10 weeks total) |
|
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D000857 | Olfaction Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |