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)

Acorda Therapeutics22 sites in 4 countries89 target enrollmentApril 2013

ConditionsIdiopathic Parkinson's Disease

InterventionsCVT-301 Placebo

DrugsCVT-301 Placebo

Overview

Phase: Phase 2
Intervention: CVT-301
Conditions: Idiopathic Parkinson's Disease
Sponsor: Acorda Therapeutics
Enrollment: 89
Locations: 22
Primary Endpoint: Change in average Unified Parkinson's Disease Rating Scale Part III motor score
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2013

End Date

January 2014

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Acorda Therapeutics

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

CVT-301

CVT-301 at Dose Level 1 for 1st 14 days of treatment then increased to Dose level 2 for last 14 days of treatment.

Intervention: CVT-301

Inhaled Placebo

Subjects randomized to receive placebo in a 1:1 randomization scheme

Intervention: Placebo

Outcomes

Primary Outcomes

Change in average Unified Parkinson's Disease Rating Scale Part III motor score

Time Frame: pre-dose to 60 minutes following treatment

Secondary Outcomes

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)