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

NCT02240030 | Completed Phase 3 Results DMC

• 1 other identifier: CVT-301-004
• Study Type: interventional
• Target: 351
• Locations: 5 countries
• Sites: 74

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. Patients who successfully complete this study will be eligible to enroll into a 12 month treatment extension (CVT-301-004E) study.

Conditions

Idiopathic Parkinson's Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Unified Parkinson's Disease Rating Scale (UPDRS) Part III

  Primary Efficacy Analysis: Change from Predose in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at 30 Minutes post-dose at Week 12 for CVT-301 High Dose versus Placebo (ITT Population). UPDRS Part III ranges from 0 minimum to 86 maximum, with lower scores indicating better movement. Units on a scale.

  30 minutes post-dose at week 12

Secondary Outcomes (5)

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

  at week 12

• UPDRS Part III Motor Score at 20 Minutes

  at week 12

• Proportion of Subjects Who Improved PGIC With CVT-301 vs. Placebo at Week 12

  week 12

• UPDRS Part III at 10 Min.

  week 12

• PD Patient Diary

  post week 12

Study Arms (3)

CVT-301 Low Dose

EXPERIMENTAL

Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration

Drug: CVT-301 Low Dose

CVT-301 High Dose

EXPERIMENTAL

Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration

Drug: CVT-301 High Dose

Placebo

PLACEBO COMPARATOR

Capsules of inhalation-grade lactose used up to 5 times/day for OFF episodes for 3 months duration.

Other: Placebo

Interventions

CVT-301 Low Dose DRUG

Also known as: Inhaled levodopa

CVT-301 Low Dose

CVT-301 High Dose DRUG

Also known as: Inhaled levodopa

CVT-301 High Dose

Placebo OTHER

Also known as: Inhalation-grade lactose

Placebo

Eligibility Criteria

• Age: 30 Years - 85 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 85 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 LD dose \<1600 mg/day;
• Able to perform a spirometry maneuver in the ON and OFF states;
• Normal cognition confirmed by 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;
• 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 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 #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 #5305

Zaspa, 80462, 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 Publications (1)

• LeWitt PA, Hauser RA, Pahwa R, Isaacson SH, Fernandez HH, Lew M, Saint-Hilaire M, Pourcher E, Lopez-Manzanares L, Waters C, Rudzinska M, Sedkov A, Batycky R, Oh C; SPAN-PD Study Investigators. Safety and efficacy of CVT-301 (levodopa inhalation powder) on motor function during off periods in patients with Parkinson's disease: a randomised, double-blind, placebo-controlled phase 3 trial. Lancet Neurol. 2019 Feb;18(2):145-154. doi: 10.1016/S1474-4422(18)30405-8.

  PMID: 30663606 DERIVED

Related Links

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

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: Charles Oh
• 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: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2014
• First Posted: September 15, 2014
• Study Start: November 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 28, 2019
• Results First Posted: April 17, 2018

Record last verified: 2019-05

Locations

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