A Study of the Safety and Tolerability of a Single Dose Administration of CVT-301 (Levodopa Inhalation Powder)

NCT ID: NCT02807675

Last Updated: 2017-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2016-11-30

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.

Conditions

Parkinson's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

CVT-301, levodopa inhalation powder (LIP)

designed to deliver l-dopa to the lung using the CVT-301 inhaler.

Group Type: EXPERIMENTAL

CVT-301, LIP

Intervention Type: DRUG

All subjects will receive 1 dose of CVT-301 and 1 dose of placebo inhalation powder, to be taken concomitantly with their standard oral medication in 2 dosing periods. The order of treatment will be randomized, with subjects assigned to 1 of 2 sequences CVT-301 (A) administered first, followed by placebo (B), or the reverse order (BA)

Placebo

Administered in the same way as the investigational product, except that it does not contain l-dopa.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

All subjects will receive 1 dose of CVT-301 and 1 dose of placebo inhalation powder, to be taken concomitantly with their standard oral medication in 2 dosing periods. The order of treatment will be randomized, with subjects assigned to 1 of 2 sequences CVT-301 (A) administered first, followed by placebo (B), or the reverse order (BA)

Interventions

CVT-301, LIP

All subjects will receive 1 dose of CVT-301 and 1 dose of placebo inhalation powder, to be taken concomitantly with their standard oral medication in 2 dosing periods. The order of treatment will be randomized, with subjects assigned to 1 of 2 sequences CVT-301 (A) administered first, followed by placebo (B), or the reverse order (BA)

Intervention Type: DRUG

Placebo

All subjects will receive 1 dose of CVT-301 and 1 dose of placebo inhalation powder, to be taken concomitantly with their standard oral medication in 2 dosing periods. The order of treatment will be randomized, with subjects assigned to 1 of 2 sequences CVT-301 (A) administered first, followed by placebo (B), or the reverse order (BA)

Intervention Type: OTHER

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Acorda Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven Komjathy, MD

Role: STUDY_DIRECTOR

Acorda Therapeutics

Locations

Site #9015

Fountain Valley, California, United States

Site #9002

Boca Raton, Florida, United States

Site #9017

Hallandale, Florida, United States

Site #9008

St. Petersburg, Florida, United States

Site #9018

Sunrise, Florida, United States

Site #9004

Tampa, Florida, United States

Site #9016

Atlanta, Georgia, United States

Site #9009

Chicago, Illinois, United States

Site #9003

Farmington Hills, Michigan, United States

Site #9005

West Bloomfield, Michigan, United States

Site #9007

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

CVT-301-009

Identifier Type: -

Identifier Source: org_study_id