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

May 23, 2019 updated by: Acorda Therapeutics

A Phase 3, Randomized Study Investigating the Safety of CVT-301 (Levodopa Inhalation Powder) in Parkinson's Disease (PD) Patients With Motor Response Fluctuations (OFF Phenomena) Compared to an Observational Cohort Control

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

408

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria, 64239
        • Acorda Site #7004
      • Linz, Austria, 04021
        • Acorda Site #7002
      • Vienna, Austria, 01220
        • Acorda Site #7003
  • Belgium
      • Brussels, Belgium, 01200
        • Acorda Site #7011
      • Edegem, Belgium, B-2650
        • Acorda Site #7012
      • Ghent, Belgium, 09000
        • Acorda Site #7013
  • Czechia
      • Chocen, Czechia, 12163
        • Acorda Site #7024
      • Ostrava, Czechia, 70852
        • Acorda Site #7025
      • Pardubice, Czechia, 27574
        • Acorda Site #7021
      • Prague 10, Czechia, 10000
        • Acorda Site #7022
      • Rychnov nad Kneznou, Czechia, 516 01
        • Acorda Site #7023
  • France
      • Amiens, France, 80054Cedex1
        • Acorda Site #7036
      • Bordeaux, France, 33000
        • Acorda Site #7037
      • MONTPELLIER Cedex 5, France, 34295
        • Acorda Site #7031
      • Marseille Cedex 05, France, 13385
        • Acorda Site #7034
      • Nimes Cedex, France, 30029
        • Acorda Site #7033
      • Strasbourg, France, 67098
        • Acorda Site #7032
      • Toulouse Cedex 9, France, 31059
        • Acorda Site #7035
  • Germany
      • Achim, Germany, 28832
        • Acorda Site #7041
      • Beelitz-Heilstätten, Germany, 14547
        • Acorda Site #7043
      • Berlin, Germany, 12163
        • Acorda Site #7049
      • Bochum, Germany, 44791
        • Acorda Site #7050
      • Bremerhaven, Germany, 27574
        • Acorda Site #7048
      • Cologne, Germany, 50937
        • Acorda Site #7047
      • Marburg, Germany, 35043
        • Acorda Site #7046
      • Munich, Germany, 80804
        • Acorda Site #7042
      • Ulm, Germany, 89081
        • Acorda Site #7044
  • Hungary
      • Budapest, Hungary, 01033
        • Acorda Site #7053
      • Budapest, Hungary, 01135
        • Acorda Site #7051
  • Israel
      • Jerusalem, Israel, 91120
        • Acorda Site #7062
      • Petah Tikva, Israel, 49100
        • Acorda Site #7064
      • Ramat Gan, Israel, 5265601
        • Acorda Site #7061
      • Tel-Aviv, Israel, 64239
        • Acorda Site #7063
  • Netherlands
      • Den Haag, Netherlands, 83527
        • Acorda Site #7045
  • Poland
      • Gdansk, Poland, 80-462
        • Acorda Site #7085
      • Katowice, Poland, 40-588
        • Acorda Site #7084
      • Kracow, Poland, 08026
        • Acorda Site #7083
      • Kraków, Poland, 30-349
        • Acorda Site #7086
      • Kraków, Poland, 31-505
        • Acorda Site #7087
      • Lodz, Poland, 90-130
        • Acorda Site #7082
      • Warsaw, Poland, 01-868
        • Acorda Site #7081
      • Warsaw, Poland, 02-097
        • Acorda Site #7088
  • Romania
      • Brasov, Romania, 500283
        • Acorda Site #7094
      • Brasov, Romania, 500365
        • Acorda Site #7092
      • Bucharest, Romania, 12051
        • Acorda Site #7093
      • Constanta, Romania, 900591
        • Acorda Site #7091
      • Targu Mures, Romania, 540136
        • Acorda Site #7095
  • Serbia
      • Belgrade, Serbia, 11000
        • Acorda Site #7101
      • Belgrade, Serbia, 11000
        • Acorda Site #7102
      • Kragujevac, Serbia, 34000
        • Acorda Site #7103
  • Spain
      • Barcelona, Spain, 08026
        • Acorda Site #7116
      • Barcelona, Spain, 08028
        • Acorda Site #7111
      • Barcelona, Spain, 08035
        • Acorda Site #7120
      • Barcelona, Spain, 08036
        • Acorda Site #7119
      • Burgos, Spain, 09006
        • Acorda Site #7113
      • Madrid, Spain, 28006
        • Acorda Site #7118
      • Madrid, Spain, 28046
        • Acorda Site #7114
      • San Sebastian, Spain, 20009
        • Acorda Site #7115
    • Barcelona
      • Sant Cugat, Barcelona, Spain, 08195
        • Acorda Site #7112
  • United Kingdom
      • Cambridge, United Kingdom, CB2 0QQ
        • Acorda Site #7123
      • Glasgow, United Kingdom, G51 4TF
        • Acorda Site #7121
      • London, United Kingdom, W6 8RF
        • Acorda Site #7122
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Acorda Site #7145
    • California
      • Fountain Valley, California, United States, 92708
        • Acorda Site # 7142
      • Panorama City, California, United States, 91402
        • Acorda Site #7139
      • Sunnyvale, California, United States, 94085
        • Acorda Site #7141
    • Florida
      • Ormond Beach, Florida, United States, 32174
        • Acorda Site #7137
      • Saint Petersburg, Florida, United States, 33713
        • Acorda Site #7135
      • Sunrise, Florida, United States, 33351
        • Acorda Site #7130
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Acorda Site #7133
      • Atlanta, Georgia, United States, 30342
        • Acorda Site #7134
      • Decatur, Georgia, United States, 30033
        • Acorda Site #7131
    • Hawaii
      • Honolulu, Hawaii, United States, 96734
        • Acorda Site #7138
    • Iowa
      • Des Moines, Iowa, United States, 50309
        • Acorda Site #7140
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70810
        • Acorda Site #7150
    • Ohio
      • Toledo, Ohio, United States, 43614
        • Acorda Site #7148

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CVT-301
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
Other Names:
  • Inhaled levodopa
Other: 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.
Other: Observational cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulmonary Safety Assessed by Forced Expiratory Volume in 1 Second [FEV1]
Time Frame: Month 12 reported
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].
Time Frame: Month 12 reported
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.
Time Frame: Month 12 reported
To characterize the pulmonary safety, as assessed by spirometry (forced expiratory volume in 1 second / forced vital capacity ratio).
Month 12 reported

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diffusion Capacity of the Lungs for Carbon Monoxide (DLco).
Time Frame: Month 12 reported
To describe the effects of CVT-301 on diffusion capacity of the lungs for carbon monoxide (DLco) over a 12-month period.
Month 12 reported

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acorda Therapeutics

Investigators

  • Study Director: Charles Oh, MD, Acorda Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

January 26, 2015

First Submitted That Met QC Criteria

January 30, 2015

First Posted (Estimate)

February 2, 2015

Study Record Updates

Last Update Posted (Actual)

May 28, 2019

Last Update Submitted That Met QC Criteria

May 23, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CVT-301-005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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