Randomized Safety Study of CVT-301 Compared to an Observational Control Group

NCT02352363 | Completed Phase 3 Results DMC

• 1 other identifier: CVT-301-005
• Study Type: interventional
• Target: 408
• Locations: 14 countries
• Sites: 76

Brief Summary

This study is a 12-month, open-label, randomized, multicenter study which will evaluate the safety and efficacy of CVT-301 for the treatment of up to 5 OFF episodes per day in Parkinson's Disease (PD) patients experiencing motor fluctuations (OFF episodes) and will include a concurrent observational cohort of PD patients managed using the usual standards of care.

Conditions

Idiopathic Parkinson's Disease

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Pulmonary Safety Assessed by Forced Expiratory Volume in 1 Second [FEV1]

  To characterize the pulmonary safety, as assessed by spirometry (forced expiratory volume in 1 second \[FEV1\], over a 12 month period.

  Month 12 reported

• Pulmonary Safety Assessed by Forced Vital Capacity [FVC].

  To characterize the pulmonary safety, as assessed by spirometry (forced vital capacity).

  Month 12 reported

• Pulmonary Safety Assessed by Forced Expiratory Volume in 1 Second / Forced Vital Capacity Ratio.

  To characterize the pulmonary safety, as assessed by spirometry (forced expiratory volume in 1 second / forced vital capacity ratio).

  Month 12 reported

Secondary Outcomes (1)

• Diffusion Capacity of the Lungs for Carbon Monoxide (DLco).

  Month 12 reported

Study Arms (2)

CVT-301

EXPERIMENTAL

Capsules of Levodopa Inhalational Powder (LIP) used up to 5 times per day for OFF episodes, for up to 54 weeks duration.

Drug: CVT-301

Observational Cohort

OTHER

Standard of care. Patients in both the CVT-301 treatment group and the observational cohort will be managed with their standard PD treatment throughout the study.

Other: Observational cohort

Interventions

CVT-301 DRUG

Also known as: Inhaled levodopa

CVT-301

Observational cohort OTHER

Observational Cohort

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has signed and dated an Internal Review Board/Independent Ethics Committee (IRB/IEC)-approved informed consent form before any protocol-specific screening procedures are performed.
• Women of child-bearing potential must use protocol-defined contraceptive measures and must have a negative serum human chorionic gonadotropin (hCG) test at screening. These patients must be willing to remain on their current form of contraception for the duration of the study.
• Patients who 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.
• Patients who are classified as Stage 1 to 3 (in the ON state) on the modified Hoehn and Yahr scale for staging of PD severity.
• Patients who have experienced motor fluctuations for a minimum of 2 hours of average daily OFF time per waking day (excluding early morning OFF time) by self-report and confirmed by the PD Diary (on 3 consecutive days) during the screening period.

You may not qualify if:

• Patients who have dyskinesia of a severity that would significantly interfere with their ability to participate or perform study procedures.
• Pregnant or lactating females or females wishing to become pregnant.
• Patients who have any known contraindication to the use of levodopa (LD), including a history of malignant melanoma or a history of narrow-angle glaucoma.
• Patients who have had previous surgery for PD (including but not limited to deep brain stimulation \[DBS\] or cell transplantation).
• Patients with a history of psychotic symptoms requiring treatment, or suicide ideation or attempt within the prior 12 months.

Sponsors & Collaborators

• Acorda Therapeutics: lead

Study Sites (76)

Acorda Site #7145

Scottsdale, Arizona, 85258, United States

Location

Acorda Site # 7142

Fountain Valley, California, 92708, United States

Location

Acorda Site #7139

Panorama City, California, 91402, United States

Location

Acorda Site #7141

Sunnyvale, California, 94085, United States

Location

Acorda Site #7137

Ormond Beach, Florida, 32174, United States

Location

Acorda Site #7135

St. Petersburg, Florida, 33713, United States

Location

Acorda Site #7130

Sunrise, Florida, 33351, United States

Location

Acorda Site #7133

Atlanta, Georgia, 30342, United States

Location

Acorda Site #7134

Atlanta, Georgia, 30342, United States

Location

Acorda Site #7131

Decatur, Georgia, 30033, United States

Location

Acorda Site #7138

Honolulu, Hawaii, 96734, United States

Location

Acorda Site #7140

Des Moines, Iowa, 50309, United States

Location

Acorda Site #7150

Baton Rouge, Louisiana, 70810, United States

Location

Acorda Site #7148

Toledo, Ohio, 43614, United States

Location

Acorda Site #7004

Innsbruck, 64239, Austria

Location

Acorda Site #7002

Linz, 04021, Austria

Location

Acorda Site #7003

Vienna, 01220, Austria

Location

Acorda Site #7011

Brussels, 01200, Belgium

Location

Acorda Site #7012

Edegem, B-2650, Belgium

Location

Acorda Site #7013

Ghent, 09000, Belgium

Location

Acorda Site #7024

Choceň, 12163, Czechia

Location

Acorda Site #7025

Ostrava, 70852, Czechia

Location

Acorda Site #7021

Pardubice, 27574, Czechia

Location

Acorda Site #7022

Prague, 10000, Czechia

Location

Acorda Site #7023

Rychnov nad Kněžnou, 516 01, Czechia

Location

Acorda Site #7036

Amiens, 80054Cedex1, France

Location

Acorda Site #7037

Bordeaux, 33000, France

Location

Acorda Site #7034

Marseille, 13385, France

Location

Acorda Site #7031

Montpellier, 34295, France

Location

Acorda Site #7033

Nîmes, 30029, France

Location

Acorda Site #7032

Strasbourg, 67098, France

Location

Acorda Site #7035

Toulouse, 31059, France

Location

Acorda Site #7041

Achim, 28832, Germany

Location

Acorda Site #7043

Beelitz-Heilstätten, 14547, Germany

Location

Acorda Site #7049

Berlin, 12163, Germany

Location

Acorda Site #7050

Bochum, 44791, Germany

Location

Acorda Site #7048

Bremerhaven, 27574, Germany

Location

Acorda Site #7047

Cologne, 50937, Germany

Location

Acorda Site #7046

Marburg, 35043, Germany

Location

Acorda Site #7042

Munich, 80804, Germany

Location

Acorda Site #7044

Ulm, 89081, Germany

Location

Acorda Site #7053

Budapest, 01033, Hungary

Location

Acorda Site #7051

Budapest, 01135, Hungary

Location

Acorda Site #7062

Jerusalem, 91120, Israel

Location

Acorda Site #7064

Petah Tikva, 49100, Israel

Location

Acorda Site #7061

Ramat Gan, 5265601, Israel

Location

Acorda Site #7063

Tel Aviv, 64239, Israel

Location

Acorda Site #7045

The Hague, 83527, Netherlands

Location

Acorda Site #7085

Gdansk, 80-462, Poland

Location

Acorda Site #7084

Katowice, 40-588, Poland

Location

Acorda Site #7083

Kracow, 08026, Poland

Location

Acorda Site #7086

Krakow, 30-349, Poland

Location

Acorda Site #7087

Krakow, 31-505, Poland

Location

Acorda Site #7082

Lodz, 90-130, Poland

Location

Acorda Site #7081

Warsaw, 01-868, Poland

Location

Acorda Site #7088

Warsaw, 02-097, Poland

Location

Acorda Site #7094

Brasov, 500283, Romania

Location

Acorda Site #7092

Brasov, 500365, Romania

Location

Acorda Site #7093

Bucharest, 12051, Romania

Location

Acorda Site #7091

Constanța, 900591, Romania

Location

Acorda Site #7095

Târgu Mureş, 540136, Romania

Location

Acorda Site #7101

Belgrade, 11000, Serbia

Location

Acorda Site #7102

Belgrade, 11000, Serbia

Location

Acorda Site #7103

Kragujevac, 34000, Serbia

Location

Acorda Site #7112

Sant Cugat del Vallès, Barcelona, 08195, Spain

Location

Acorda Site #7116

Barcelona, 08026, Spain

Location

Acorda Site #7111

Barcelona, 08028, Spain

Location

Acorda Site #7120

Barcelona, 08035, Spain

Location

Acorda Site #7119

Barcelona, 08036, Spain

Location

Acorda Site #7113

Burgos, 09006, Spain

Location

Acorda Site #7115

Donostia / San Sebastian, 20009, Spain

Location

Acorda Site #7118

Madrid, 28006, Spain

Location

Acorda Site #7114

Madrid, 28046, Spain

Location

Acorda Site #7123

Cambridge, CB2 0QQ, United Kingdom

Location

Acorda Site #7121

Glasgow, G51 4TF, United Kingdom

Location

Acorda Site #7122

London, W6 8RF, United Kingdom

Location

Related Publications (1)

• Kaminsky DA, Grosset DG, Kegler-Ebo DM, Cangiamilla S, Klingler M, Zhao P, Oh C. Natural history of lung function over one year in patients with Parkinson's disease. Respir Med. 2021 Jun;182:106396. doi: 10.1016/j.rmed.2021.106396. Epub 2021 Apr 16.

  PMID: 33866196 DERIVED

Related Links

• Click here for more information about this study:CVT-301-005

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: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2015
• First Posted: February 2, 2015
• Study Start: March 1, 2015
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: May 28, 2019
• Results First Posted: July 10, 2018

Record last verified: 2019-05

Locations

ES (9); DE (9); FR (7); NL (1); BE (3); RO (5); AU (3); SE (3); US (14); HU (2); GB (3); IL (4); CZ (5); PL (8)