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

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ClinicalTrials.gov Identifier: NCT02242487
Recruitment Status : Completed
First Posted : September 17, 2014
Results First Posted : July 30, 2019
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Acorda Therapeutics

Tracking Information
First Submitted Date  ICMJE September 15, 2014
First Posted Date  ICMJE September 17, 2014
Results First Submitted Date  ICMJE June 12, 2019
Results First Posted Date  ICMJE July 30, 2019
Last Update Posted Date August 14, 2019
Study Start Date  ICMJE March 2015
Actual Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 10, 2019)
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 15, 2014)
Pulmonary safety of CVT-301. [ Time Frame: change from baseline through 12 months duration of outpatient use ]
Spirometry assessment of FEV1 and FEV1/FVC ratio
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2019)
  • 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).
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2014)
  • Safety and tolerability of CVT-301. [ Time Frame: change from baseline through 12 months duration of outpatient use ]
    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 Part III motor score [ Time Frame: pre-dose to 60 minutes following treatment ]
  • Total daily OFF time and daily ON time ± dyskinesia (troublesome/nontroublesome) [ Time Frame: change from baseline through 12 months duration of outpatient use ]
    Patient recorded PD diary
  • Effect of CVT-301 on activities of daily living and quality of life [ Time Frame: change from baseline through 12 months duration of outpatient use ]
    Schwab & England Activities of Daily Living, UPDRS Part 2, PDQ-39
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Twelve Month Safety and Efficacy Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes
Official Title  ICMJE 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)
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Idiopathic Parkinson's Disease
Intervention  ICMJE Drug: CVT-301
Other Name: Inhaled levodopa
Study Arms  ICMJE
  • Experimental: CVT-301 Low Dose
    Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 12 months duration
    Intervention: Drug: CVT-301
  • Experimental: CVT-301 High Dose
    Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 12 months duration
    Intervention: Drug: CVT-301
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 30, 2017)
325
Original Estimated Enrollment  ICMJE
 (submitted: September 15, 2014)
350
Actual Study Completion Date  ICMJE May 2018
Actual Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 86 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Czechia,   Poland,   Spain,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02242487
Other Study ID Numbers  ICMJE CVT-301-004E
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Acorda Therapeutics
Study Sponsor  ICMJE Acorda Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Charles Oh, MD Acorda Therapeutics
PRS Account Acorda Therapeutics
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP