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

NCT ID: NCT02352363

Last Updated: 2019-05-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

408 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2017-05-31

Brief Summary

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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.

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Detailed Description

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A randomized, double-blind, placebo-controlled, Phase 2b study in patients with PD (CVT-301-003) demonstrated clinically important, and statistically significant CVT-301-associated improvements in motor function at doses of 35 and 50 mg LD FPD, compared with placebo, as measured by the Unified Parkinson's Disease Rating Scale (UPDRS) motor assessment (Part 3); furthermore, CVT-301 was generally safe and well tolerated. A Phase 3, randomized, placebo-controlled study designed to assess the efficacy and safety of 35 mg and 50 mg FPD as an adjunct to a CD/LD regimen in the treatment of OFF symptoms over 12 weeks (CVT-301-004) was conducted in parallel with this study.

Conditions

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Idiopathic Parkinson's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CVT-301

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

Group Type EXPERIMENTAL

CVT-301

Intervention Type DRUG

Observational Cohort

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.

Group Type OTHER

Observational cohort

Intervention Type OTHER

Interventions

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CVT-301

Intervention Type DRUG

Observational cohort

Intervention Type OTHER

Other Intervention Names

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Inhaled levodopa

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Acorda Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Charles Oh, MD

Role: STUDY_DIRECTOR

Acorda Therapeutics

Locations

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Acorda Site #7145

Scottsdale, Arizona, United States

Site Status

Acorda Site # 7142

Fountain Valley, California, United States

Site Status

Acorda Site #7139

Panorama City, California, United States

Site Status

Acorda Site #7141

Sunnyvale, California, United States

Site Status

Acorda Site #7137

Ormond Beach, Florida, United States

Site Status

Acorda Site #7135

St. Petersburg, Florida, United States

Site Status

Acorda Site #7130

Sunrise, Florida, United States

Site Status

Acorda Site #7133

Atlanta, Georgia, United States

Site Status

Acorda Site #7134

Atlanta, Georgia, United States

Site Status

Acorda Site #7131

Decatur, Georgia, United States

Site Status

Acorda Site #7138

Honolulu, Hawaii, United States

Site Status

Acorda Site #7140

Des Moines, Iowa, United States

Site Status

Acorda Site #7150

Baton Rouge, Louisiana, United States

Site Status

Acorda Site #7148

Toledo, Ohio, United States

Site Status

Acorda Site #7004

Innsbruck, , Austria

Site Status

Acorda Site #7002

Linz, , Austria

Site Status

Acorda Site #7003

Vienna, , Austria

Site Status

Acorda Site #7011

Brussels, , Belgium

Site Status

Acorda Site #7012

Edegem, , Belgium

Site Status

Acorda Site #7013

Ghent, , Belgium

Site Status

Acorda Site #7024

Choceň, , Czechia

Site Status

Acorda Site #7025

Ostrava, , Czechia

Site Status

Acorda Site #7021

Pardubice, , Czechia

Site Status

Acorda Site #7022

Prague, , Czechia

Site Status

Acorda Site #7023

Rychnov nad Kněžnou, , Czechia

Site Status

Acorda Site #7036

Amiens, , France

Site Status

Acorda Site #7037

Bordeaux, , France

Site Status

Acorda Site #7034

Marseille, , France

Site Status

Acorda Site #7031

Montpellier, , France

Site Status

Acorda Site #7033

Nîmes, , France

Site Status

Acorda Site #7032

Strasbourg, , France

Site Status

Acorda Site #7035

Toulouse, , France

Site Status

Acorda Site #7041

Achim, , Germany

Site Status

Acorda Site #7043

Beelitz-Heilstätten, , Germany

Site Status

Acorda Site #7049

Berlin, , Germany

Site Status

Acorda Site #7050

Bochum, , Germany

Site Status

Acorda Site #7048

Bremerhaven, , Germany

Site Status

Acorda Site #7047

Cologne, , Germany

Site Status

Acorda Site #7046

Marburg, , Germany

Site Status

Acorda Site #7042

Munich, , Germany

Site Status

Acorda Site #7044

Ulm, , Germany

Site Status

Acorda Site #7053

Budapest, , Hungary

Site Status

Acorda Site #7051

Budapest, , Hungary

Site Status

Acorda Site #7062

Jerusalem, , Israel

Site Status

Acorda Site #7064

Petah Tikva, , Israel

Site Status

Acorda Site #7061

Ramat Gan, , Israel

Site Status

Acorda Site #7063

Tel Aviv, , Israel

Site Status

Acorda Site #7045

The Hague, , Netherlands

Site Status

Acorda Site #7085

Gdansk, , Poland

Site Status

Acorda Site #7084

Katowice, , Poland

Site Status

Acorda Site #7083

Kracow, , Poland

Site Status

Acorda Site #7086

Krakow, , Poland

Site Status

Acorda Site #7087

Krakow, , Poland

Site Status

Acorda Site #7082

Lodz, , Poland

Site Status

Acorda Site #7081

Warsaw, , Poland

Site Status

Acorda Site #7088

Warsaw, , Poland

Site Status

Acorda Site #7094

Brasov, , Romania

Site Status

Acorda Site #7092

Brasov, , Romania

Site Status

Acorda Site #7093

Bucharest, , Romania

Site Status

Acorda Site #7091

Constanța, , Romania

Site Status

Acorda Site #7095

Târgu Mureş, , Romania

Site Status

Acorda Site #7101

Belgrade, , Serbia

Site Status

Acorda Site #7102

Belgrade, , Serbia

Site Status

Acorda Site #7103

Kragujevac, , Serbia

Site Status

Acorda Site #7112

Sant Cugat del Vallès, Barcelona, Spain

Site Status

Acorda Site #7116

Barcelona, , Spain

Site Status

Acorda Site #7111

Barcelona, , Spain

Site Status

Acorda Site #7120

Barcelona, , Spain

Site Status

Acorda Site #7119

Barcelona, , Spain

Site Status

Acorda Site #7113

Burgos, , Spain

Site Status

Acorda Site #7115

Donostia / San Sebastian, , Spain

Site Status

Acorda Site #7118

Madrid, , Spain

Site Status

Acorda Site #7114

Madrid, , Spain

Site Status

Acorda Site #7123

Cambridge, , United Kingdom

Site Status

Acorda Site #7121

Glasgow, , United Kingdom

Site Status

Acorda Site #7122

London, , United Kingdom

Site Status

Countries

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United States Austria Belgium Czechia France Germany Hungary Israel Netherlands Poland Romania Serbia Spain United Kingdom

References

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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.

Reference Type DERIVED
PMID: 33866196 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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http://cvt301.acordatrials.com/

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

Other Identifiers

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CVT-301-005

Identifier Type: -

Identifier Source: org_study_id

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