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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Civitas Therapeutics
ClinicalTrials.gov Identifier:
NCT01777555
First received: January 23, 2013
Last updated: April 3, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Idiopathic Parkinson's Disease
Drug: CVT-301
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:


Further study details as provided by Civitas Therapeutics:

Primary Outcome Measures:
  • Change in average Unified Parkinson's Disease Rating Scale Part III motor score [ Time Frame: pre-dose to 60 minutes following treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to resolution of OFF episode to an ON state. [ Time Frame: 28 days duration outpatient treatment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
    Adverse experiences, ECGs, vital signs, clinical laboratory evaluation, pulmonary function using spirometry


Enrollment: 89
Study Start Date: April 2013
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Drug: Placebo

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01777555

Locations
United States, Arkansas
Civitas Investigational Site 1013
Little Rock, Arkansas, United States
United States, Florida
Civitas Investigational Site 1004
Boca Raton, Florida, United States
Civitas Investigational Site 1002
Port Charlotte, Florida, United States
Civitas Investigational Site 1015
Tampa, Florida, United States
United States, Kansas
Civitas Investigational Site 1007
Kansas City, Kansas, United States
United States, Massachusetts
Civitas Investigational Site 1010
Boston, Massachusetts, United States
United States, Michigan
Civitas Investigational Site 1001
Bingham Farms, Michigan, United States
Civitas Investigational Site 1008
Roseville, Michigan, United States
Civitas Investigational Site 1009
St. Louis, Michigan, United States
Civitas Investigational Site 1005
West Bloomfield, Michigan, United States
United States, New York
Civitas Investigational Site 1011
Kingston, New York, United States
United States, Ohio
Civitas Investigational Site 1014
Cleveland, Ohio, United States
United States, Washington
Civitas Investigational Site 1003
Kirkland, Washington, United States
Italy
Civitas Investigational Site 4003
Cassino, Italy
Civitas Investigational Site 4002
Chieti, Italy
Civitas Investigational Site 4001
Rome, Italy
Serbia
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
Civitas Therapeutics
Investigators
Study Chair: Martin Freed, MD Civitas Therapeutics
  More Information

No publications provided

Responsible Party: Civitas Therapeutics
ClinicalTrials.gov Identifier: NCT01777555     History of Changes
Other Study ID Numbers: CVT-301-003, 2012-005822-31
Study First Received: January 23, 2013
Last Updated: April 3, 2014
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Italy: The Italian Medicines Agency

Keywords provided by Civitas Therapeutics:
Parkinson's Disease
Motor fluctuations
levodopa
inhaled drugs
Off episodes

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Levodopa
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 16, 2014