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)

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

Sponsors

Lead sponsor: Acorda Therapeutics

Source 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.

Overall Status Completed
Start Date April 2013
Completion Date January 2014
Primary Completion Date January 2014
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in average Unified Parkinson's Disease Rating Scale Part III motor score pre-dose to 60 minutes following treatment
Secondary Outcome
Measure Time Frame
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
Enrollment 89
Condition
Intervention

Intervention type: Drug

Intervention name: CVT-301

Arm group label: CVT-301

Other name: Levodopa Inhalation Powder

Intervention type: Drug

Intervention name: Placebo

Arm group label: Inhaled Placebo

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.

Gender: All

Minimum age: 30 Years

Maximum age: 80 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Martin Freed, MD Study Chair Acorda Therapeutics
Location
facility
Civitas Investigational Site 1013 | Little Rock, Arkansas, 72201, United States
Civitas Investigational Site 1004 | Boca Raton, Florida, 33427, United States
Civitas Investigational Site 1002 | Port Charlotte, Florida, 33948, United States
Civitas Investigational Site 1015 | Tampa, Florida, 33601, United States
Civitas Investigational Site 1007 | Kansas City, Kansas, 66101, United States
Civitas Investigational Site 1010 | Boston, Massachusetts, 02108, United States
Civitas Investigational Site 1001 | Bingham Farms, Michigan, 48025, United States
Civitas Investigational Site 1008 | Roseville, Michigan, 48066, United States
Civitas Investigational Site 1009 | Saint Louis, Michigan, 48880, United States
Civitas Investigational Site 1005 | West Bloomfield, Michigan, 48322, United States
Civitas Investigational Site 1011 | Kingston, New York, 12401, United States
Civitas Investigational Site 1014 | Cleveland, Ohio, 44101, United States
Civitas Investigational Site 1003 | Kirkland, Washington, 98033, United States
Civitas Investigational Site 4003 | Cassino, Italy
Civitas Investigational Site 4002 | Chieti, Italy
Civitas Investigational Site 4001 | Rome, Italy
Civitas Investigational Site 3001 | Belgrade, Serbia
Civitas Investigational Site 3002 | Belgrade, Serbia
Civitas Investigational Site 2004 | Cambridge, United Kingdom
Civitas Investigational Site 200 | Glasgow, United Kingdom
Civitas Investigational Site 2001 | London, United Kingdom
Civitas Investigational Site 2003 | Stoke on Trent, United Kingdom
Location Countries

Italy

Serbia

United Kingdom

United States

Verification Date

May 2015

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: CVT-301

Arm group type: Experimental

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

Arm group label: Inhaled Placebo

Arm group type: Placebo Comparator

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

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov