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

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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01617135

Enrollment

Registered

2012-06-12

Start date

2012-05-31

Completion date

2012-12-31

Last updated

2017-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Parkinson's Disease

Keywords

Parkinson's disease, Motor fluctuations, levodopa, inhaled drugs, Motor fluctuation (off episodes)

Brief summary

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

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.

Interventions

DRUGCVT-301

DRUGPlacebo

DRUGSinemet (carbidopa/levodopa)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

30 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

Israel, Serbia, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026