Twelve Month Safety and Efficacy Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes

NCT02242487 | Completed Phase 3 Results DMC

• 1 other identifier: CVT-301-004E
• Study Type: interventional
• Target: 325
• Locations: 5 countries
• Sites: 74

Brief Summary

This study is a 12-month, dose-level blinded, multicenter study of 2 inhaled dose levels of CVT-301 for the treatment of up to 5 OFF episodes per day in PD patients experiencing motor fluctuations (OFF episodes). All patients will receive active treatment, but patients will be blinded to dose level. This will serve as an extension to the CVT-301-004 (NCT02240030) study for those patients who participated in that study and remain eligible for this study. In addition, patients who previously completed the CVT-301-003 (NCT01777555), CVT-301-009 (NCT02807675) and CVT-301-005 (NCT02352363) (observational arm completers), as well as CVT-301 naïve patients may be enrolled if they meet the CVT-301-004E eligibility criteria.

Conditions

Idiopathic Parkinson's Disease

Keywords

Parkinson's Disease; Motor fluctuations; levodopa; inhaled drugs; OFF episodes

Outcome Measures

Primary Outcomes (3)

• Pulmonary Safety of CVT-301 Change From Baseline for FEV1.

  To characterize the effects of CVT-301 on pulmonary safety, as assessed by spirometry FEV1 (forced expiratory volume in 1 second) by treatment group and Treatment Visit (TV). This study was a 12-month, dose-level blinded, multi-center study of 2 inhaled dose levels of CVT-301 for the treatment of up to 5 OFF periods per day in PD (Parkinson's Disease) patients experiencing motor fluctuations (OFF periods). Baseline is defined as the last non-missing assessment before the first dose of CVT-301 in CVT-301-004 study and as the last non-missing assessment before the first dose of CVT-301 in CVT-301-004E study for the rest of the patients.

  Change from baseline at 52 weeks

• Pulmonary Safety for CVT-301 Change From Baseline for FVC.

  To characterize the effects of CVT-301 on pulmonary safety, as assessed by spirometry FVC, (forced vital capacity) by treatment group and Treatment Visit (TV). This study was a 12-month, dose-level blinded, multi-center study of 2 inhaled dose levels of CVT-301 for the treatment of up to 5 OFF periods per day in PD patients experiencing motor fluctuations (OFF periods). Baseline is defined as the last non-missing assessment before the first dose of CVT-301 in CVT-301-004 study and as the last non-missing assessment before the first dose of CVT-301 in CVT-301-004E study for the rest of the patients.

  Change from baseline at 52 weeks

• Pulmonary Safety for CVT-301 Change From Baseline for (FEV1/FVC).

  To characterize the effects of CVT-301 on pulmonary safety, as assessed by spirometry FEV1/FVC (FEV1-forced expiratory volume in 1 second and (FVC) forced vital capacity ratio) by treatment group and Treatment Visit (TV). This study was a 12-month, dose-level blinded, multi-center study of 2 inhaled dose levels of CVT-301 for the treatment of up to 5 OFF periods per day in PD (Parkinson's Disease) patients experiencing motor fluctuations (OFF periods). Baseline is defined as the last non-missing assessment before the first dose of CVT-301 in CVT-301-004 study and as the last non-missing assessment before the first dose of CVT-301 in CVT-301-004E study for the rest of the patients.

  Change from baseline at 52 weeks

Secondary Outcomes (2)

• Count of Patients Achieving Resolution of an OFF to an ON State Within 60 Minutes.

  At Treatment Visit - TV6 (Week 52)

• Change From Baseline in OFF Time.

  Change from baseline through 12 months duration of outpatient use

Study Arms (2)

CVT-301 Low Dose

EXPERIMENTAL

Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 12 months duration

Drug: CVT-301

CVT-301 High Dose

EXPERIMENTAL

Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 12 months duration

Drug: CVT-301

Interventions

CVT-301 DRUG

Also known as: Inhaled levodopa

CVT-301 High Dose; CVT-301 Low Dose

Eligibility Criteria

• Age: 30 Years - 86 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 3 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;
• Total daily levodopa (LD) dose \<1600 mg/day;
• Able to perform a spirometry maneuver in the ON and OFF states
• Normal cognition confirmed by Mini Mental State Examination (MMSE) score ≥25 ;

You may not qualify if:

• Pregnant or lactating females;
• Previous surgery for PD or plan to have stereotactic surgery during the study period. Patients who have had deep brain stimulation \[DBS\] will also be excluded unless the procedure was performed more than 6 months prior to study enrollment.
• History of psychotic symptoms requiring treatment, or suicide ideation or attempt within last year;
• Known contraindication to the use of levodopa;
• Any significant condition, severe concurrent disease, abnormality or finding that would make patients unsuitable or may compromise patient safety;
• Any any contraindication to performing routine spirometry.

Sponsors & Collaborators

• Acorda Therapeutics: lead

Study Sites (74)

Acorda Site #5020

Scottsdale, Arizona, 85259, United States

Location

Acorda Site #5042

Fresno, California, 93710, United States

Location

Acorda Site #5064

Fullerton, California, 92835, United States

Location

Acorda Site #5035

Loma Linda, California, 92354, United States

Location

Acorda Site #5027

Long Beach, California, 90806, United States

Location

Acorda Site #5037

Los Angeles, California, 90033, United States

Location

Acorda Site #5070

Pasadena, California, 91105, United States

Location

Acorda Site #5047

Reseda, California, 91335, United States

Location

Acorda Site #5068

Santa Ana, California, 92705, United States

Location

Acorda Site #5069

Torrance, California, 90505, United States

Location

Acorda Site #5052

Washington D.C., District of Columbia, 20007, United States

Location

Acorda Site #5046

Atlantis, Florida, 33462, United States

Location

Acorda Site #5053

Aventura, Florida, 33180, United States

Location

Acorda Site #5013

Boca Raton, Florida, 33486, United States

Location

Acorda Site #5016

Jacksonville, Florida, 32209, United States

Location

Acorda Site #5071

Maitland, Florida, 32751, United States

Location

Acorda Site #5044

Orlando, Florida, 32806, United States

Location

Acorda Site #5060

Palm Beach Gardens, Florida, 33410, United States

Location

Acorda Site #5001

Port Charlotte, Florida, 33952, United States

Location

Acorda Site #5065

St. Petersburg, Florida, 33713, United States

Location

Acorda Site #5012

Tampa, Florida, 33613, United States

Location

Acorda Site #5040

Atlanta, Georgia, 30329, United States

Location

Acorda Site #5025

Chicago, Illinois, 60611, United States

Location

Acorda Site #5030

Chicago, Illinois, 60612, United States

Location

Acorda Site #5011

Elk Grove Village, Illinois, 60007, United States

Location

Acorda Site #5003

Kansas City, Kansas, 66160, United States

Location

Acorda Site #5067

Baton Rouge, Louisiana, 70810, United States

Location

Acorda Site #5057

Baltimore, Maryland, 21201, United States

Location

Acorda Site #5056

Boston, Massachusetts, 02114, United States

Location

Acorda Site #5018

Boston, Massachusetts, 02118, United States

Location

Acorda Site #5002

Bingham Farms, Michigan, 48025, United States

Location

Acorda Site #5014

West Bloomfield, Michigan, 48322, United States

Location

Acorda Site #5041

Golden Valley, Minnesota, 55427, United States

Location

Acorda Site #5006

St Louis, Missouri, 63110, United States

Location

Acorda Site #5023

Las Vegas, Nevada, 89102, United States

Location

Acorda Site #5028

Albany, New York, 12208, United States

Location

Acorda Site #5039

Brooklyn, New York, 11203, United States

Location

Acorda Site #5031

New York, New York, 10016, United States

Location

Acorda Site #5032

New York, New York, 10029, United States

Location

Acorda Site #5004

New York, New York, 10032, United States

Location

Acorda Site #5038

Syracuse, New York, 13210, United States

Location

Acorda Site #5048

Charlotte, North Carolina, 28204, United States

Location

Acorda Site #5005

Cleveland, Ohio, 44195, United States

Location

Acorda Site #5050

Norwood, Ohio, 45212, United States

Location

Acorda Site #5062

Portland, Oregon, 97239, United States

Location

Acorda Site #5036

Allentown, Pennsylvania, 18103, United States

Location

Acorda Site #5010

Philadelphia, Pennsylvania, 19107, United States

Location

Acorda Site #5058

Willow Grove, Pennsylvania, 19090, United States

Location

Acorda Site #5022

Charleston, South Carolina, 29425, United States

Location

Acorda Site #5029

Nashville, Tennessee, 372322551, United States

Location

Acorda Site #5019

Houston, Texas, 77030, United States

Location

Acorda Site #5045

Houston, Texas, 77030, United States

Location

Acorda Site #5049

Henrico, Virginia, 23226, United States

Location

Acorda Site #5059

Virginia Beach, Virginia, 23456, United States

Location

Acorda Site #5051

Kirkland, Washington, 98034, United States

Location

Acorda Site #5103

London, Ontario, N6A5A5, Canada

Location

Acorda Site #5104

Ottawa, Ontario, K1Y4E9, Canada

Location

Acorda Site #5105

Toronto, Ontario, M5T2S8, Canada

Location

Acorda Site #5201

Prague, 10000, Czechia

Location

Acorda Site #5203

Prague, 14000, Czechia

Location

Acorda Site #5305

Gdansk, Zappa, 80462, Poland

Location

Acorda Site #5304

Katowice, 40588, Poland

Location

Acorda Site #5306

Krakow, 30349, Poland

Location

Acorda Site #5303

Krakow, 30510, Poland

Location

Acorda Site #5307

Krakow, 31505, Poland

Location

Acorda Site #5302

Lodz, 90130, Poland

Location

Acorda Site #5308

Warsaw, 00453, Poland

Location

Acorda Site #5301

Warsaw, 01868, Poland

Location

Acorda Site #5407

Pamplona, Navarre, 31008, Spain

Location

Acorda Site #5404

Barcelona, 08026, Spain

Location

Acorda Site #5406

Barcelona, 08035, Spain

Location

Acorda Site #5405

Madrid, 28006, Spain

Location

Acorda Site #5403

San Sebastián, 20009, Spain

Location

Acorda Site #5401

Sant Cugat del Vallès, 08190, Spain

Location

Related Links

• Click here for more information about this study:CVT-301-004E

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Dr. Charles Oh, Senior Vice President - Clinical Development
• Organization: Acorda Therapeutics

coh@acorda.com

914-326-5455

Study Officials

• Charles Oh, MD

  Acorda Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2014
• First Posted: September 17, 2014
• Study Start: March 1, 2015
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: August 14, 2019
• Results First Posted: July 30, 2019

Record last verified: 2019-07

Locations

US (55); ES (6); CZ (2); CA (3); PL (8)