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

July 30, 2019 updated by: Acorda Therapeutics

A 12 Month, Dose-Level Blinded Study Investigating the Safety and Efficacy of CVT 301 (Levodopa Inhalation Powder) in Parkinson's Disease Patients With Motor Response Fluctuations (OFF Phenomena)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
325

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A5A5
        • Acorda Site #5103
      • Ottawa, Ontario, Canada, K1Y4E9
        • Acorda Site #5104
      • Toronto, Ontario, Canada, M5T2S8
        • Acorda Site #5105
  • Czechia
      • Prague, Czechia, 10000
        • Acorda Site #5201
      • Prague, Czechia, 14000
        • Acorda Site #5203
  • Poland
      • Katowice, Poland, 40588
        • Acorda Site #5304
      • Krakow, Poland, 30510
        • Acorda Site #5303
      • Kraków, Poland, 30349
        • Acorda Site #5306
      • Kraków, Poland, 31505
        • Acorda Site #5307
      • Lodz, Poland, 90130
        • Acorda Site #5302
      • Warsaw, Poland, 00453
        • Acorda Site #5308
      • Warsaw, Poland, 01868
        • Acorda Site #5301
    • Zappa
      • Gdańsk, Zappa, Poland, 80462
        • Acorda Site #5305
  • Spain
      • Barcelona, Spain, 08026
        • Acorda Site #5404
      • Barcelona, Spain, 08035
        • Acorda Site #5406
      • Madrid, Spain, 28006
        • Acorda Site #5405
      • San Sebastián, Spain, 20009
        • Acorda Site #5403
      • Sant Cugat Del Vallès, Spain, 08190
        • Acorda Site #5401
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Acorda Site #5407
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Acorda Site #5020
    • California
      • Fresno, California, United States, 93710
        • Acorda Site #5042
      • Fullerton, California, United States, 92835
        • Acorda Site #5064
      • Loma Linda, California, United States, 92354
        • Acorda Site #5035
      • Long Beach, California, United States, 90806
        • Acorda Site #5027
      • Los Angeles, California, United States, 90033
        • Acorda Site #5037
      • Pasadena, California, United States, 91105
        • Acorda Site #5070
      • Reseda, California, United States, 91335
        • Acorda Site #5047
      • Santa Ana, California, United States, 92705
        • Acorda Site #5068
      • Torrance, California, United States, 90505
        • Acorda Site #5069
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Acorda Site #5052
    • Florida
      • Atlantis, Florida, United States, 33462
        • Acorda Site #5046
      • Aventura, Florida, United States, 33180
        • Acorda Site #5053
      • Boca Raton, Florida, United States, 33486
        • Acorda Site #5013
      • Jacksonville, Florida, United States, 32209
        • Acorda Site #5016
      • Maitland, Florida, United States, 32751
        • Acorda Site #5071
      • Orlando, Florida, United States, 32806
        • Acorda Site #5044
      • Palm Beach Gardens, Florida, United States, 33410
        • Acorda Site #5060
      • Port Charlotte, Florida, United States, 33952
        • Acorda Site #5001
      • Saint Petersburg, Florida, United States, 33713
        • Acorda Site #5065
      • Tampa, Florida, United States, 33613
        • Acorda Site #5012
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Acorda Site #5040
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Acorda Site #5025
      • Chicago, Illinois, United States, 60612
        • Acorda Site #5030
      • Elk Grove Village, Illinois, United States, 60007
        • Acorda Site #5011
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Acorda Site #5003
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70810
        • Acorda Site #5067
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Acorda Site #5057
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Acorda Site #5056
      • Boston, Massachusetts, United States, 02118
        • Acorda Site #5018
    • Michigan
      • Bingham Farms, Michigan, United States, 48025
        • Acorda Site #5002
      • West Bloomfield, Michigan, United States, 48322
        • Acorda Site #5014
    • Minnesota
      • Golden Valley, Minnesota, United States, 55427
        • Acorda Site #5041
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Acorda Site #5006
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Acorda Site #5023
    • New York
      • Albany, New York, United States, 12208
        • Acorda Site #5028
      • Brooklyn, New York, United States, 11203
        • Acorda Site #5039
      • New York, New York, United States, 10016
        • Acorda Site #5031
      • New York, New York, United States, 10029
        • Acorda Site #5032
      • New York, New York, United States, 10032
        • Acorda Site #5004
      • Syracuse, New York, United States, 13210
        • Acorda Site #5038
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Acorda Site #5048
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Acorda Site #5005
      • Norwood, Ohio, United States, 45212
        • Acorda Site #5050
    • Oregon
      • Portland, Oregon, United States, 97239
        • Acorda Site #5062
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Acorda Site #5036
      • Philadelphia, Pennsylvania, United States, 19107
        • Acorda Site #5010
      • Willow Grove, Pennsylvania, United States, 19090
        • Acorda Site #5058
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Acorda Site #5022
    • Tennessee
      • Nashville, Tennessee, United States, 372322551
        • Acorda Site #5029
    • Texas
      • Houston, Texas, United States, 77030
        • Acorda Site #5019
      • Houston, Texas, United States, 77030
        • Acorda Site #5045
    • Virginia
      • Henrico, Virginia, United States, 23226
        • Acorda Site #5049
      • Virginia Beach, Virginia, United States, 23456
        • Acorda Site #5059
    • Washington
      • Kirkland, Washington, United States, 98034
        • Acorda Site #5051

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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 ;

Exclusion Criteria:

  • 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.

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CVT-301 Low Dose
Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 12 months duration
Drug: CVT-301
Other Names:
  • Inhaled levodopa
Experimental: CVT-301 High Dose
Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 12 months duration
Drug: CVT-301
Other Names:
  • Inhaled levodopa

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pulmonary Safety of CVT-301 Change From Baseline for FEV1.
Time Frame: Change from baseline at 52 weeks
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.
Time Frame: Change from baseline at 52 weeks
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).
Time Frame: Change from baseline at 52 weeks
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Count of Patients Achieving Resolution of an OFF to an ON State Within 60 Minutes.
Time Frame: At Treatment Visit - TV6 (Week 52)
Count of patients achieving resolution of an OFF to an ON state within 60 minutes after study drug is administered in the clinic, and maintaining the ON state at 60 minutes after study drug administration (per the examiner's subjective assessment).
At Treatment Visit - TV6 (Week 52)
Change From Baseline in OFF Time.
Time Frame: Change from baseline through 12 months duration of outpatient use
Patient reported total daily OFF time and was assessed by the patient and recorded in the patient Diary. An "OFF state" is defined as the time when medication is not providing benefit with respect to mobility, slowness, and stiffness. OFF episodes may be heralded by non-motor symptoms (e.g., pain, anxiety) prior to the appearance of motor symptoms. Patients will record their ON and OFF states in their diaries at home.
Change from baseline through 12 months duration of outpatient use

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Acorda Therapeutics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 15, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 17, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CVT-301-004E

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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