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Trial record 1 of 2 for:    CVT-301-005
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Randomized Safety Study of CVT-301 Compared to an Observational Control Group

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ClinicalTrials.gov Identifier: NCT02352363
Recruitment Status : Completed
First Posted : February 2, 2015
Last Update Posted : October 17, 2017
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

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
Primary Completion Date : May 2017
Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Levodopa
U.S. FDA Resources

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 within the CVT-301 treated patients, assessed by spirometry (forced expiratory volume in 1 second [FEV1], forced vital capacity [FVC] and FEV1/FVC ratio) [ Time Frame: Over a 12-month period ]

Secondary Outcome Measures :
  1. Pulmonary safety within the observational (standard of care) cohort, assessed by spirometry FEV1, FVC and FEV1/FVC ratio. [ Time Frame: Over a 12-month period ]
  2. Difference between the CVT-301-treated patients and the observational cohort on measures of pulmonary safety [ Time Frame: Over a 12-month period ]
  3. Safety of CVT-301 measured by the number of patients with Adverse Events (AEs) [ Time Frame: Over a 12-month period ]
  4. Effect of CVT-301 on mean change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part 4 measures of motor fluctuations (dyskinesias and wearing off) [ Time Frame: Pre-dose, at 6 and 12 months ]
  5. Occurrence and severity of examiner-rated dyskinesia following CVT-301 treatment of patients experiencing an OFF episode in the clinic [ Time Frame: Over a 12-month period ]
  6. Effect of CVT-301 on carbon monoxide diffusing capacity (DLco) [ Time Frame: 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, Senior)
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 ClinicalTrials.gov identifier (NCT number): NCT02352363

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Sponsors and Collaborators
Acorda Therapeutics
Study Director: Charles Oh, MD Acorda Therapeutics

Additional Information:
Responsible Party: Acorda Therapeutics
ClinicalTrials.gov Identifier: NCT02352363     History of Changes
Other Study ID Numbers: CVT-301-005
First Posted: February 2, 2015    Key Record Dates
Last Update Posted: October 17, 2017
Last Verified: May 2017

Keywords provided by Acorda Therapeutics:
Parkinson's Disease
Motor fluctuations
inhaled drugs
OFF episodes

Additional relevant MeSH terms:
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