Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012-005822-31 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This randomized, multicenter, placebo-controlled, double-blind study will evaluate the efficacy and safety of inhaled CVT 301 compared with placebo in PD patients experiencing motor response fluctuations (OFF phenomena) as an outpatient (i.e., at home) and in the clinic.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CVT-301 | Experimental | CVT-301 at Dose Level 1 for 1st 14 days of treatment then increased to Dose level 2 for last 14 days of treatment. |
|
| Inhaled Placebo | Placebo Comparator | Subjects randomized to receive placebo in a 1:1 randomization scheme |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CVT-301 | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in average Unified Parkinson's Disease Rating Scale Part III motor score | pre-dose to 60 minutes following treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Time to resolution of OFF episode to an ON state. | 28 days duration outpatient treatment | |
| To characterize the safety (including pulmonary safety)of CVT-301 when used chronically to provide relief from OFF episodes. | Adverse experiences, ECGs, vital signs, clinical laboratory evaluation, pulmonary function using spirometry |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Martin Freed, MD | Acorda Therapeutics | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Civitas Investigational Site 1013 | Little Rock | Arkansas | 72201 | United States | ||
| Civitas Investigational Site 1004 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
| change from baseline through 28 days outpatient use |
| Boca Raton |
| Florida |
| 33427 |
| United States |
| Civitas Investigational Site 1002 | Port Charlotte | Florida | 33948 | United States |
| Civitas Investigational Site 1015 | Tampa | Florida | 33601 | United States |
| Civitas Investigational Site 1007 | Kansas City | Kansas | 66101 | United States |
| Civitas Investigational Site 1010 | Boston | Massachusetts | 02108 | United States |
| Civitas Investigational Site 1001 | Bingham Farms | Michigan | 48025 | United States |
| Civitas Investigational Site 1008 | Roseville | Michigan | 48066 | United States |
| Civitas Investigational Site 1009 | Saint Louis | Michigan | 48880 | United States |
| Civitas Investigational Site 1005 | West Bloomfield | Michigan | 48322 | United States |
| Civitas Investigational Site 1011 | Kingston | New York | 12401 | United States |
| Civitas Investigational Site 1014 | Cleveland | Ohio | 44101 | United States |
| Civitas Investigational Site 1003 | Kirkland | Washington | 98033 | United States |
| Civitas Investigational Site 4003 | Cassino | Italy |
| Civitas Investigational Site 4002 | Chieti | Italy |
| Civitas Investigational Site 4001 | Rome | Italy |
| Civitas Investigational Site 3001 | Belgrade | Serbia |
| Civitas Investigational Site 3002 | Belgrade | Serbia |
| Civitas Investigational Site 2004 | Cambridge | United Kingdom |
| Civitas Investigational Site 200 | Glasgow | United Kingdom |
| Civitas Investigational Site 2001 | London | United Kingdom |
| Civitas Investigational Site 2003 | Stoke-on-Trent | United Kingdom |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
Not provided
Not provided