Safety, Pharmacokinetics and Efficacy Study of CVT-301 Inpatients With Parkinson's Disease and Off Episodes

Study Overview
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Brief Summary
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The purpose of this study is to determine the safety, efficacy and pharmacokinetics following administration of CVT-301 in treatment of off episodes in Parkinson's Disease patients.

Detailed Description
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Treatment options for patients with motor response fluctuations are limited. Most commonly, off episodes are managed by adjusting the dose interval of their standard oral medications or by self-administration of unscheduled doses of oral Parkinson's medication. Due to the variability in levodopa absorption following oral dosing, resumption of motor function is unreliable and may be delayed for an hour or more. CVT-301 delivers levodopa using a simple inhaler, resulting in rapid increases in levodopa blood levels and is expected to result in rapid restoration in motor function for patients experiencing off episodes.

Official Title
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A Randomized, Placebo-Controlled, Phase 2 Study of the Safety, Pharmacokinetics and Pharmacodynamics of CVT-310 (Levodopa Inhalation Powder) in Patients With Parkinson's Disease and Motor Response Fluctuations (Off Episodes)

Conditions
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Idiopathic Parkinson's Disease

Intervention / Treatment
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* Drug: CVT-301
* Drug: Placebo
* Drug: Sinemet (carbidopa/levodopa)
* Drug: CVT-301


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

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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CVT-301 Low Dose<br>CVT-Low; levodopa inhalation powder (LIP) | Drug: CVT-301<br> <br> |
| Experimental: CVT-301 High Dose<br>CVT-High; levodopa inhalation powder (LIP) | Drug: CVT-301<br> <br> |
| Placebo Comparator: Inhaled Placebo<br>Inhaled placebo powder | Drug: Placebo<br> <br> |
| Active Comparator: Oral Sinemet (carbidopa/levodopa)<br>Open-label oral carbidopa/levodopa (CD/LD) | Drug: Sinemet (carbidopa/levodopa)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Adverse experiences, ECGs, clinical laboratory evaluation, pulmonary function | change from baseline up to 13 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacodynamics | Time to onset of meaningful on and off states (patient- and examiner-assessed) UPDRS III motor score Tapping test Dyskinesia | 3 hours post-dose | 
| Pharmacokinetics | Serial blood draw for determination of plasma concentration-time profile | 3 hours post-dose | 

 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, Motor fluctuation (off episodes)