Status:
COMPLETED
Twelve Month Safety and Efficacy Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes
Lead Sponsor:
Acorda Therapeutics
Conditions:
Idiopathic Parkinson's Disease
Eligibility:
All Genders
30-86 years
Phase:
PHASE3
Brief Summary
This study is a 12-month, dose-level blinded, multicenter study of 2 inhaled dose levels of CVT-301 for the treatment of up to 5 OFF episodes per day in PD patients experiencing motor fluctuations (OF...
Eligibility Criteria
Inclusion
- Idiopathic Parkinson's Disease (PD) diagnosed between the ages of 30 and 80 years;
- Hoehn and Yahr Stage 1-3 in an "on" state;
- Require levodopa-containing medication regimen at least 3 times during the waking day;
- Experience motor fluctuations with a minimum of 2 hours of average daily "off" time per waking day (excluding early morning "off" time) and demonstrate levodopa responsiveness;
- Are on stable PD medication regimen;
- Total daily levodopa (LD) dose \<1600 mg/day;
- Able to perform a spirometry maneuver in the ON and OFF states
- Normal cognition confirmed by Mini Mental State Examination (MMSE) score ≥25 ;
Exclusion
- Pregnant or lactating females;
- Previous surgery for PD or plan to have stereotactic surgery during the study period. Patients who have had deep brain stimulation \[DBS\] will also be excluded unless the procedure was performed more than 6 months prior to study enrollment.
- History of psychotic symptoms requiring treatment, or suicide ideation or attempt within last year;
- Known contraindication to the use of levodopa;
- Any significant condition, severe concurrent disease, abnormality or finding that would make patients unsuitable or may compromise patient safety;
- Any any contraindication to performing routine spirometry.
Key Trial Info
Start Date :
March 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2018
Estimated Enrollment :
325 Patients enrolled
Trial Details
Trial ID
NCT02242487
Start Date
March 1 2015
End Date
May 1 2018
Last Update
August 14 2019
Active Locations (74)
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1
Acorda Site #5020
Scottsdale, Arizona, United States, 85259
2
Acorda Site #5042
Fresno, California, United States, 93710
3
Acorda Site #5064
Fullerton, California, United States, 92835
4
Acorda Site #5035
Loma Linda, California, United States, 92354