Clinical trial NCT01777555: Efficacy and Safety Study of Inhaled CVT 301 in Parkinson's Disease Patients for Treatment of OFF Episodes
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Idiopathic Parkinson's Disease
Keywords: Parkinson's Disease
Motor fluctuations
levodopa
inhaled drugs
Off episodes
Lead sponsor: Acorda Therapeutics
Sponsor class: INDUSTRY
First posted: 2013-01-29
Enrollment: 89
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Change in average Unified Parkinson's Disease Rating Scale Part III motor score
timeFrame: pre-dose to 60 minutes following treatment
Secondary outcomes:
measure: Time to resolution of OFF episode to an ON state.
timeFrame: 28 days duration outpatient treatment
measure: To characterize the safety (including pulmonary safety)of CVT-301 when used chronically to provide relief from OFF episodes.
timeFrame: change from baseline through 28 days outpatient use
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Civitas Investigational Site 1013
state: Arkansas
city: Boca Raton
country: United States
facility: Civitas Investigational Site 1004
state: Florida
city: Port Charlotte
country: United States
facility: Civitas Investigational Site 1002
state: Florida
city: Tampa
country: United States
facility: Civitas Investigational Site 1015
state: Florida
city: Kansas City
country: United States
facility: Civitas Investigational Site 1007
state: Kansas
city: Boston
country: United States
facility: Civitas Investigational Site 1010
state: Massachusetts
city: Bingham Farms
country: United States
facility: Civitas Investigational Site 1001
state: Michigan
city: Roseville
country: United States
facility: Civitas Investigational Site 1008
state: Michigan
city: Saint Louis
country: United States
facility: Civitas Investigational Site 1009
state: Michigan
city: West Bloomfield
country: United States
facility: Civitas Investigational Site 1005
state: Michigan
city: Kingston
country: United States
facility: Civitas Investigational Site 1011
state: New York
city: Cleveland
country: United States
facility: Civitas Investigational Site 1014
state: Ohio
city: Kirkland
country: United States
facility: Civitas Investigational Site 1003
state: Washington
city: Cassino
country: Italy
facility: Civitas Investigational Site 4003
city: Chieti
country: Italy
facility: Civitas Investigational Site 4002
city: Rome
country: Italy
facility: Civitas Investigational Site 4001
city: Belgrade
country: Serbia
facility: Civitas Investigational Site 3001
city: Belgrade
country: Serbia
facility: Civitas Investigational Site 3002
city: Cambridge
country: United Kingdom
facility: Civitas Investigational Site 2004
city: Glasgow
country: United Kingdom
facility: Civitas Investigational Site 200
city: London
country: United Kingdom
facility: Civitas Investigational Site 2001
city: Stoke on Trent
country: United Kingdom
facility: Civitas Investigational Site 2003
Study officials:
affiliation: Acorda Therapeutics
name: Martin Freed, MD
role: STUDY_CHAIR
References: