Clinical trial NCT01617135: Safety, Pharmacokinetics and Efficacy Study of CVT-301 Inpatients With Parkinson's Disease and "Off" Episodes
Official title: A Randomized, Placebo-Controlled, Phase 2 Study of the Safety, Pharmacokinetics and Pharmacodynamics of CVT-310 (Levodopa Inhalation Powder) in Patients With Parkinson's Disease and Motor Response Fluctuations ("Off Episodes")
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Idiopathic Parkinson's Disease
Keywords: Parkinson's disease
Motor fluctuations
levodopa
inhaled drugs
Motor fluctuation ("off episodes")
Lead sponsor: Acorda Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Michael J. Fox Foundation for Parkinson's Research
First posted: 2012-06-12
Enrollment: 25
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety, efficacy and pharmacokinetics following administration of CVT-301 in treatment of "off" episodes in Parkinson's Disease patients.

Detailed description: Treatment options for patients with motor response fluctuations are limited. Most commonly, "off" episodes are managed by adjusting the dose interval of their standard oral medications or by self-administration of unscheduled doses of oral Parkinson's medication. Due to the variability in levodopa absorption following oral dosing, resumption of motor function is unreliable and may be delayed for an hour or more. CVT-301 delivers levodopa using a simple inhaler, resulting in rapid increases in levodopa blood levels and is expected to result in rapid restoration in motor function for patients experiencing "off" episodes.

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: Safety
timeFrame: change from baseline up to 13 weeks
Secondary outcomes:
measure: Pharmacodynamics
timeFrame: 3 hours post-dose
measure: Pharmacokinetics
timeFrame: 3 hours post-dose
Other outcomes:
Locations:
city: Petach-Tikva
country: Israel
facility: Civitas Clinical Site #6
city: Tel Aviv
country: Israel
facility: Civitas Clinical Site #5
city: Belgrade
country: Serbia
facility: Civitas Clinical Site #4
city: Belgrade
country: Serbia
facility: Civitas Clinical Site #7
city: Glasgow
country: United Kingdom
facility: Civitas Clinical Site #1
city: Newcastle
country: United Kingdom
facility: Civitas Clinical Site #3
city: Norwich
country: United Kingdom
facility: Civitas Clinical Site #2
Study officials:
References: