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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02352363
Recruitment Status : Completed
First Posted : February 2, 2015
Results First Posted : July 10, 2018
Last Update Posted : May 28, 2019
Information provided by (Responsible Party):
Acorda Therapeutics

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.

Condition or disease Intervention/treatment Phase
Idiopathic Parkinson's Disease Drug: CVT-301 Other: Observational cohort Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 408 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2015
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Levodopa

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 Name: Inhaled levodopa

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

Primary Outcome Measures :
  1. 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.

  2. 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).

  3. 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).

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02352363

Hide Hide 76 study locations
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United States, Arizona
Acorda Site #7145
Scottsdale, Arizona, United States, 85258
United States, California
Acorda Site # 7142
Fountain Valley, California, United States, 92708
Acorda Site #7139
Panorama City, California, United States, 91402
Acorda Site #7141
Sunnyvale, California, United States, 94085
United States, Florida
Acorda Site #7137
Ormond Beach, Florida, United States, 32174
Acorda Site #7135
Saint Petersburg, Florida, United States, 33713
Acorda Site #7130
Sunrise, Florida, United States, 33351
United States, Georgia
Acorda Site #7133
Atlanta, Georgia, United States, 30342
Acorda Site #7134
Atlanta, Georgia, United States, 30342
Acorda Site #7131
Decatur, Georgia, United States, 30033
United States, Hawaii
Acorda Site #7138
Honolulu, Hawaii, United States, 96734
United States, Iowa
Acorda Site #7140
Des Moines, Iowa, United States, 50309
United States, Louisiana
Acorda Site #7150
Baton Rouge, Louisiana, United States, 70810
United States, Ohio
Acorda Site #7148
Toledo, Ohio, United States, 43614
Acorda Site #7004
Innsbruck, Austria, 64239
Acorda Site #7002
Linz, Austria, 04021
Acorda Site #7003
Vienna, Austria, 01220
Acorda Site #7011
Brussels, Belgium, 01200
Acorda Site #7012
Edegem, Belgium, B-2650
Acorda Site #7013
Ghent, Belgium, 09000
Acorda Site #7024
Chocen, Czechia, 12163
Acorda Site #7025
Ostrava, Czechia, 70852
Acorda Site #7021
Pardubice, Czechia, 27574
Acorda Site #7022
Prague 10, Czechia, 10000
Acorda Site #7023
Rychnov nad Kneznou, Czechia, 516 01
Acorda Site #7036
Amiens, France, 80054Cedex1
Acorda Site #7037
Bordeaux, France, 33000
Acorda Site #7034
Marseille Cedex 05, France, 13385
Acorda Site #7031
MONTPELLIER Cedex 5, France, 34295
Acorda Site #7033
Nimes Cedex, France, 30029
Acorda Site #7032
Strasbourg, France, 67098
Acorda Site #7035
Toulouse Cedex 9, France, 31059
Acorda Site #7041
Achim, Germany, 28832
Acorda Site #7043
Beelitz-Heilstätten, Germany, 14547
Acorda Site #7049
Berlin, Germany, 12163
Acorda Site #7050
Bochum, Germany, 44791
Acorda Site #7048
Bremerhaven, Germany, 27574
Acorda Site #7047
Cologne, Germany, 50937
Acorda Site #7046
Marburg, Germany, 35043
Acorda Site #7042
Munich, Germany, 80804
Acorda Site #7044
Ulm, Germany, 89081
Acorda Site #7053
Budapest, Hungary, 01033
Acorda Site #7051
Budapest, Hungary, 01135
Acorda Site #7062
Jerusalem, Israel, 91120
Acorda Site #7064
Petah Tikva, Israel, 49100
Acorda Site #7061
Ramat Gan, Israel, 5265601
Acorda Site #7063
Tel-Aviv, Israel, 64239
Acorda Site #7045
Den Haag, Netherlands, 83527
Acorda Site #7085
Gdansk, Poland, 80-462
Acorda Site #7084
Katowice, Poland, 40-588
Acorda Site #7083
Kracow, Poland, 08026
Acorda Site #7086
Kraków, Poland, 30-349
Acorda Site #7087
Kraków, Poland, 31-505
Acorda Site #7082
Lodz, Poland, 90-130
Acorda Site #7081
Warsaw, Poland, 01-868
Acorda Site #7088
Warsaw, Poland, 02-097
Acorda Site #7094
Brasov, Romania, 500283
Acorda Site #7092
Brasov, Romania, 500365
Acorda Site #7093
Bucharest, Romania, 12051
Acorda Site #7091
Constanta, Romania, 900591
Acorda Site #7095
Targu Mures, Romania, 540136
Acorda Site #7101
Belgrade, Serbia, 11000
Acorda Site #7102
Belgrade, Serbia, 11000
Acorda Site #7103
Kragujevac, Serbia, 34000
Acorda Site #7112
Sant Cugat, Barcelona, Spain, 08195
Acorda Site #7116
Barcelona, Spain, 08026
Acorda Site #7111
Barcelona, Spain, 08028
Acorda Site #7120
Barcelona, Spain, 08035
Acorda Site #7119
Barcelona, Spain, 08036
Acorda Site #7113
Burgos, Spain, 09006
Acorda Site #7118
Madrid, Spain, 28006
Acorda Site #7114
Madrid, Spain, 28046
Acorda Site #7115
San Sebastian, Spain, 20009
United Kingdom
Acorda Site #7123
Cambridge, United Kingdom, CB2 0QQ
Acorda Site #7121
Glasgow, United Kingdom, G51 4TF
Acorda Site #7122
London, United Kingdom, W6 8RF
Sponsors and Collaborators
Acorda Therapeutics
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Study Director: Charles Oh, MD Acorda Therapeutics
  Study Documents (Full-Text)

Documents provided by Acorda Therapeutics:
Study Protocol  [PDF] September 22, 2015
Statistical Analysis Plan  [PDF] June 5, 2017

Additional Information:
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Responsible Party: Acorda Therapeutics Identifier: NCT02352363    
Other Study ID Numbers: CVT-301-005
First Posted: February 2, 2015    Key Record Dates
Results First Posted: July 10, 2018
Last Update Posted: May 28, 2019
Last Verified: May 2019
Keywords provided by Acorda Therapeutics:
Parkinson's Disease
Motor fluctuations
inhaled drugs
OFF episodes
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs