Clinical trial NCT02807675: A Study of the Safety and Tolerability of a Single Dose Administration of CVT-301 (Levodopa Inhalation Powder)
Official title: A Phase 1 Study of the Safety and Tolerability of a Single Dose Administration of CVT- 301 (Levodopa Inhalation Powder) When Administered for Early Morning OFF Symptoms in Patients With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Parkinson's Disease
Lead sponsor: Acorda Therapeutics
Sponsor class: INDUSTRY
First posted: 2016-06-21
Enrollment: 36
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is a double-blind, randomized, placebo-controlled, 2-way crossover study to evaluate the safety of CVT-301 levodopa (l-dopa) when co- administered with the first daily dose of oral levodopa/carbidopa for early morning OFF symptoms in patients with Parkinson's disease (PD).

Detailed description: An "OFF state" is defined as the time when medication is no longer providing benefit with respect to mobility, slowness, and stiffness. OFF episodes may be heralded by non-motor symptoms (e.g., pain, anxiety) prior to the appearance of motor symptoms.

Eligibility criteria: Inclusion Criteria:

* have idiopathic PD (i.e., not induced by drugs or other diseases) as defined by fulfilling Steps 1 and 2 of the United Kingdom (UK) Brain Bank criteria, diagnosed after the age of 30 years
* diagnosis of Parkinson's disease and motor fluctuations and early morning OFF symptoms
* classified as Stage 1 to 3 on the modified Hoehn and Yahr scale for staging of PD severity (in an ON state)
* subjects who are on a l-dopa-containing therapy, not including Rytary (or equivalent), must be stable on oral l-dopa-containing therapy for at least 2 weeks prior to the Screening Visit with a l-dopa/decarboxylase inhibitor (DDI)-containing regimen
* subjects who are on a l-dopa-containing therapy, when including Rytary (or equivalent), should be on a stable dose for at least 6 weeks prior to the Screening Visit
* the frequency of l-dopa administrations must be at least 3 times during the waking day and a total daily l-dopa dose of ≤ 1600 mg.
* on a stable regimen of their standard PD medications
* on a stable regimen of any blood pressure reducing medications (if applicable) for at least 30 days prior to screening
* forced expiratory volume in one second (FEV1) ≥60% of predicted for race, age, sex, and height and FEV1/FVC (forced vital capacity) ratio ≥70%
* no clinically significant abnormalities that would affect ability to complete study as determined by medical history, physical examination, electrocardiogram, clinical laboratory test results
* negative drug and alcohol testing
* negative pregnancy test for all women.

Exclusion Criteria:

* participated in any prior study with CVT-301
* dyskinesia of a severity that would significantly interfere with the subject's ability to participate or perform study procedures (as determined by the UPDRS Part 4)
* any contraindication to performing routine spirometry or who are unable to perform a spirometry maneuver
* have a current history of symptomatic orthostatic hypotension or are treated with medications to treat orthostatic hypotension (for example droxidopa, fludrocortisone), if they have severe dysautonomia
* have chronic obstructive pulmonary disease (COPD), asthma, or another chronic respiratory disease within the last 5 years.

Primary outcomes:
measure: Number of patients with Adverse Events (AEs) including Serious AEs
timeFrame: up to 9 days
Secondary outcomes:
measure: Examiner rated time to ON comparisons between treatments (CVT-301 and placebo)
timeFrame: day 1 and day 3
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: Site #9015
state: California
city: Boca Raton
country: United States
facility: Site #9002
state: Florida
city: Hallandale
country: United States
facility: Site #9017
state: Florida
city: Saint Petersburg
country: United States
facility: Site #9008
state: Florida
city: Sunrise
country: United States
facility: Site #9018
state: Florida
city: Tampa
country: United States
facility: Site #9004
state: Florida
city: Atlanta
country: United States
facility: Site #9016
state: Georgia
city: Chicago
country: United States
facility: Site #9009
state: Illinois
city: Farmington Hills
country: United States
facility: Site #9003
state: Michigan
city: West Bloomfield
country: United States
facility: Site #9005
state: Michigan
city: Nashville
country: United States
facility: Site #9007
state: Tennessee
Study officials:
affiliation: Acorda Therapeutics
name: Steven Komjathy, MD
role: STUDY_DIRECTOR
References: