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

Idiopathic Parkinson's Disease Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01777555
• Other study ID #: CVT-301-003
• Secondary ID: 2012-005822-31
• Status: Completed
• Phase: Phase 2
• Start date: April 2013
• Est. completion date: January 2014

Study information

• Verified date: May 2015
• Source: Acorda Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Idiopathic Parkinson's Disease
• Parkinson Disease

Intervention

Drug:
• CVT-301

• Placebo

Locations

Country	Name	City	State
Italy	Civitas Investigational Site 4003	Cassino
Italy	Civitas Investigational Site 4002	Chieti
Italy	Civitas Investigational Site 4001	Rome
Serbia	Civitas Investigational Site 3001	Belgrade
Serbia	Civitas Investigational Site 3002	Belgrade
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 States	Civitas Investigational Site 1001	Bingham Farms	Michigan
United States	Civitas Investigational Site 1004	Boca Raton	Florida
United States	Civitas Investigational Site 1010	Boston	Massachusetts
United States	Civitas Investigational Site 1014	Cleveland	Ohio
United States	Civitas Investigational Site 1007	Kansas City	Kansas
United States	Civitas Investigational Site 1011	Kingston	New York
United States	Civitas Investigational Site 1003	Kirkland	Washington
United States	Civitas Investigational Site 1013	Little Rock	Arkansas
United States	Civitas Investigational Site 1002	Port Charlotte	Florida
United States	Civitas Investigational Site 1008	Roseville	Michigan
United States	Civitas Investigational Site 1009	Saint Louis	Michigan
United States	Civitas Investigational Site 1015	Tampa	Florida
United States	Civitas Investigational Site 1005	West Bloomfield	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Acorda Therapeutics

Countries where clinical trial is conducted

United States,  Italy,  Serbia,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in average Unified Parkinson's Disease Rating Scale Part III motor score		pre-dose to 60 minutes following treatment
Secondary	Time to resolution of OFF episode to an ON state.		28 days duration outpatient treatment
Secondary	To characterize the safety (including pulmonary safety)of CVT-301 when used chronically to provide relief from OFF episodes.	Adverse experiences, ECGs, vital signs, clinical laboratory evaluation, pulmonary function using spirometry	change from baseline through 28 days outpatient use