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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01777555
Recruitment Status : Completed
First Posted : January 29, 2013
Last Update Posted : August 8, 2018
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Idiopathic Parkinson's Disease Drug: CVT-301 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : April 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Levodopa

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 Name: Levodopa Inhalation Powder

Placebo Comparator: Inhaled Placebo
Subjects randomized to receive placebo in a 1:1 randomization scheme
Drug: Placebo

Primary Outcome Measures :
  1. Change in average Unified Parkinson's Disease Rating Scale Part III motor score [ Time Frame: pre-dose to 60 minutes following treatment ]

Secondary Outcome Measures :
  1. Time to resolution of OFF episode to an ON state. [ Time Frame: 28 days duration outpatient treatment ]
  2. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01777555

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United States, Arkansas
Civitas Investigational Site 1013
Little Rock, Arkansas, United States, 72201
United States, Florida
Civitas Investigational Site 1004
Boca Raton, Florida, United States, 33427
Civitas Investigational Site 1002
Port Charlotte, Florida, United States, 33948
Civitas Investigational Site 1015
Tampa, Florida, United States, 33601
United States, Kansas
Civitas Investigational Site 1007
Kansas City, Kansas, United States, 66101
United States, Massachusetts
Civitas Investigational Site 1010
Boston, Massachusetts, United States, 02108
United States, Michigan
Civitas Investigational Site 1001
Bingham Farms, Michigan, United States, 48025
Civitas Investigational Site 1008
Roseville, Michigan, United States, 48066
Civitas Investigational Site 1009
Saint Louis, Michigan, United States, 48880
Civitas Investigational Site 1005
West Bloomfield, Michigan, United States, 48322
United States, New York
Civitas Investigational Site 1011
Kingston, New York, United States, 12401
United States, Ohio
Civitas Investigational Site 1014
Cleveland, Ohio, United States, 44101
United States, Washington
Civitas Investigational Site 1003
Kirkland, Washington, United States, 98033
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
United Kingdom
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
Sponsors and Collaborators
Acorda Therapeutics
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Study Chair: Martin Freed, MD Acorda Therapeutics

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Responsible Party: Acorda Therapeutics Identifier: NCT01777555     History of Changes
Other Study ID Numbers: CVT-301-003
2012-005822-31 ( EudraCT Number )
First Posted: January 29, 2013    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: May 2015
Keywords provided by Acorda Therapeutics:
Parkinson's Disease
Motor fluctuations
inhaled drugs
Off episodes
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs