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

Phase 2

Completed

• Conditions: Idiopathic Parkinson's Disease
• Interventions: Drug: CVT-301; Drug: Placebo

• Registration Number: NCT01777555
• Lead Sponsor: Acorda Therapeutics

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-01-23
• Study First Submitted QC: 2013-01-28
• Study First Posted: 2013-01-29
• Study Start: 2013-04
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2015-05
• Disposition First Submitted: 2015-05-04
• Disposition First Submitted QC: 2015-05-04
• Disposition First Posted: 2015-05-20
• Last Update Submitted: 2018-08-06
• Last Update Posted: 2018-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CVT-301	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.
Inhaled Placebo	Placebo	Subjects randomized to receive placebo in a 1:1 randomization scheme

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (22)

Civitas Investigational Site 1014; 🇺🇸 Cleveland, Ohio, United States

Civitas Investigational Site 1004; 🇺🇸 Boca Raton, Florida, United States

Civitas Investigational Site 1002; 🇺🇸 Port Charlotte, Florida, United States

Civitas Investigational Site 200; 🇬🇧 Glasgow, United Kingdom

Civitas Investigational Site 2003; 🇬🇧 Stoke on Trent, United Kingdom

Civitas Investigational Site 1010; 🇺🇸 Boston, Massachusetts, United States

Civitas Investigational Site 1009; 🇺🇸 Saint Louis, Michigan, United States

Civitas Investigational Site 1013; 🇺🇸 Little Rock, Arkansas, United States

Civitas Investigational Site 3002; 🇷🇸 Belgrade, Serbia

Civitas Investigational Site 1008; 🇺🇸 Roseville, Michigan, United States

Civitas Investigational Site 1011; 🇺🇸 Kingston, New York, United States

Civitas Investigational Site 1003; 🇺🇸 Kirkland, Washington, United States

Civitas Investigational Site 1007; 🇺🇸 Kansas City, Kansas, United States

Civitas Investigational Site 1005; 🇺🇸 West Bloomfield, Michigan, United States

Civitas Investigational Site 2001; 🇬🇧 London, United Kingdom

Civitas Investigational Site 2004; 🇬🇧 Cambridge, United Kingdom

Civitas Investigational Site 3001; 🇷🇸 Belgrade, Serbia

Civitas Investigational Site 4003; 🇮🇹 Cassino, Italy

Civitas Investigational Site 4002; 🇮🇹 Chieti, Italy

Civitas Investigational Site 4001; 🇮🇹 Rome, Italy

Civitas Investigational Site 1015; 🇺🇸 Tampa, Florida, United States

Civitas Investigational Site 1001; 🇺🇸 Bingham Farms, Michigan, United States