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

August 6, 2018 updated by: Acorda Therapeutics

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

89

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

26 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: CVT-301
Other Names:
  • Levodopa Inhalation Powder
Placebo Comparator: Inhaled Placebo
Subjects randomized to receive placebo in a 1:1 randomization scheme
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to resolution of OFF episode to an ON state.
Time Frame: 28 days duration outpatient treatment
28 days duration outpatient treatment
To characterize the safety (including pulmonary safety)of CVT-301 when used chronically to provide relief from OFF episodes.
Time Frame: change from baseline through 28 days outpatient use
Adverse experiences, ECGs, vital signs, clinical laboratory evaluation, pulmonary function using spirometry
change from baseline through 28 days outpatient use

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acorda Therapeutics

Investigators

  • Study Chair: Martin Freed, MD, Acorda Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

January 23, 2013

First Submitted That Met QC Criteria

January 28, 2013

First Posted (Estimate)

January 29, 2013

Study Record Updates

Last Update Posted (Actual)

August 8, 2018

Last Update Submitted That Met QC Criteria

August 6, 2018

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CVT-301-003
  • 2012-005822-31 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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