Efficacy and Safety Study of Inhaled CVT 301 in Parkinson's Disease Patients for Treatment of OFF Episodes

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 2b, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy and Safety of Inhaled CVT 301 (Levodopa Inhalation Powder) in Parkinson's Disease Patients With Motor Response Fluctuations (OFF Phenomena)

Conditions
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Idiopathic Parkinson's Disease

Intervention / Treatment
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* Drug: CVT-301
* Drug: Placebo


Participation Criteria
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Eligibility 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 4 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. Exclusion Criteria: Pregnant or lactating females; Previous surgery for PD or plan to have stereotactic surgery during the study period; History of psychotic symptoms requiring treatment, or suicide ideation or attempt within last year; Adequate lung function as measured by spirometry; Any significant condition, severe concurrent disease, abnormality or finding that would make patients unsuitable or may compromise patient safety.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CVT-301<br>CVT-301 at Dose Level 1 for 1st 14 days of treatment then increased to Dose level 2 for last 14 days of treatment. | Drug: CVT-301<br> <br> * Other names: Levodopa Inhalation Powder;|
| Placebo Comparator: Inhaled Placebo<br>Subjects randomized to receive placebo in a 1:1 randomization scheme | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in average Unified Parkinson's Disease Rating Scale Part III motor score |  | pre-dose to 60 minutes following treatment | 

Secondary Outcome Measures

| Outcome Measure | 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 | change from baseline through 28 days outpatient use | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's Disease, Motor fluctuations, levodopa, inhaled drugs, Off episodes