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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

January 23, 2013
April 3, 2014
April 2013
January 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01777555 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Efficacy and Safety Study of Inhaled CVT 301 in Parkinson's Disease Patients for Treatment of OFF Episodes
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Idiopathic Parkinson's Disease
  • Drug: CVT-301
    Other Name: Levodopa Inhalation Powder
  • Drug: Placebo
  • 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
    Intervention: Drug: CVT-301
  • Placebo Comparator: Inhaled Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
89
January 2014
January 2014   (final data collection date for primary outcome measure)

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.
Both
30 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Italy,   Serbia,   United Kingdom
 
NCT01777555
CVT-301-003, 2012-005822-31
No
Civitas Therapeutics
Civitas Therapeutics
Not Provided
Study Chair: Martin Freed, MD Civitas Therapeutics
Civitas Therapeutics
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP