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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by Acorda Therapeutics
Information provided by (Responsible Party):
Acorda Therapeutics Identifier:
First received: September 15, 2014
Last updated: December 21, 2015
Last verified: December 2015
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 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 study as well as additional CVT-301 naïve patients may be enrolled if they meet the CVT-301-004E eligibility criteria.

Condition Intervention Phase
Idiopathic Parkinson's Disease
Drug: CVT-301
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:

Further study details as provided by Acorda Therapeutics:

Primary Outcome Measures:
  • Pulmonary safety of CVT-301. [ Time Frame: change from baseline through 12 months duration of outpatient use ] [ Designated as safety issue: Yes ]
    Spirometry assessment of Forced Expiratory Volume in 1 second (FEV1) and FEV1/FVC (forced vital capacity) ratio

Secondary Outcome Measures:
  • Safety and tolerability of CVT-301. [ Time Frame: change from baseline through 12 months duration of outpatient use ] [ Designated as safety issue: Yes ]
    Adverse experiences, ECGs, vital signs, clinical laboratory evaluation, pulmonary function using DLco, scales to evaluate suicidality, day time sleepiness, and impulse control disorders

  • Change in average Unified Parkinson's Disease Rating Scale (UPDRS) Part III motor score from pre-dose to 60 minutes following treatment [ Time Frame: change from baseline through 12 months duration of outpatient use ] [ Designated as safety issue: No ]
  • Proportion of patients achieving resolution of an OFF to an ON state within 60 minutes. [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
    examiner-assessed observation

  • Total daily OFF time and daily ON time ± dyskinesia (troublesome/nontroublesome) [ Time Frame: change from baseline through 12 months duration of outpatient use ] [ Designated as safety issue: No ]
    Patient recorded PD diary

  • Effect of CVT-301 on activities of daily living [ Time Frame: change from baseline through 12 months duration of outpatient use ] [ Designated as safety issue: No ]
    Schwab & England Activities of Daily Living, Unified Parkinson's Disease Rating Scale (UPDRS) Part 2

  • Effect of CVT-301 on quality of life [ Time Frame: change from baseline through 12 months duration of outpatient use ] [ Designated as safety issue: No ]

Estimated Enrollment: 350
Study Start Date: March 2015
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Inhaled levodopa


Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 4 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;
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02242487

Contact: US Call Center # 1-888-979-9716

  Show 53 Study Locations
Sponsors and Collaborators
Acorda Therapeutics
Study Director: Harald Murck, MD Acorda Therapeutics
  More Information

Additional Information:
Responsible Party: Acorda Therapeutics Identifier: NCT02242487     History of Changes
Other Study ID Numbers: CVT-301-004E 
Study First Received: September 15, 2014
Last Updated: December 21, 2015
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

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

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders
Anti-Dyskinesia Agents
Antiparkinson Agents
Central Nervous System Agents
Dopamine Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on May 04, 2016