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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02242487 |
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Date of registration:
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15/09/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Twelve Month Safety and Efficacy Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes
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Scientific title:
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A 12 Month, Dose-Level Blinded Study Investigating the Safety and Efficacy of CVT 301 (Levodopa Inhalation Powder) in Parkinson's Disease Patients With Motor Response Fluctuations (OFF Phenomena) |
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Date of first enrolment:
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March 2015 |
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Target sample size:
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325 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02242487 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Canada
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Czech Republic
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Czechia
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Poland
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Spain
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United States
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Contacts
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Name:
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Charles Oh, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Acorda Therapeutics |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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 Criteria:
- 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.
Age minimum:
30 Years
Age maximum:
86 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Idiopathic Parkinson's Disease
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Intervention(s)
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Drug: CVT-301
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Primary Outcome(s)
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Pulmonary Safety for CVT-301 Change From Baseline for FVC.
[Time Frame: Change from baseline at 52 weeks]
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Pulmonary Safety for CVT-301 Change From Baseline for (FEV1/FVC).
[Time Frame: Change from baseline at 52 weeks]
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Pulmonary Safety of CVT-301 Change From Baseline for FEV1.
[Time Frame: Change from baseline at 52 weeks]
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Secondary Outcome(s)
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Change From Baseline in OFF Time.
[Time Frame: Change from baseline through 12 months duration of outpatient use]
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Count of Patients Achieving Resolution of an OFF to an ON State Within 60 Minutes.
[Time Frame: At Treatment Visit - TV6 (Week 52)]
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Secondary ID(s)
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CVT-301-004E
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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