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

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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01777555

Enrollment

Registered

2013-01-29

Start date

2013-04-30

Completion date

2014-01-31

Last updated

2018-08-08

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, Off episodes

Brief summary

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.

Interventions

DRUGCVT-301

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

30 Years to 80 Years

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
Change in average Unified Parkinson's Disease Rating Scale Part III motor score	pre-dose to 60 minutes following treatment

Secondary

Measure	Time frame	Description
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.	change from baseline through 28 days outpatient use	Adverse experiences, ECGs, vital signs, clinical laboratory evaluation, pulmonary function using spirometry

Countries

Italy, Serbia, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026