Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 2 for:    CVT-301-005
Previous Study | Return to List | Next Study

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.
ClinicalTrials.gov Identifier: NCT02352363
Recruitment Status : Completed
First Posted : February 2, 2015
Results First Posted : July 10, 2018
Last Update Posted : May 27, 2019
Sponsor:
Information provided by (Responsible Party):
Acorda Therapeutics

Tracking Information
First Submitted Date  ICMJE January 26, 2015
First Posted Date  ICMJE February 2, 2015
Results First Submitted Date  ICMJE June 4, 2018
Results First Posted Date  ICMJE July 10, 2018
Last Update Posted Date May 27, 2019
Study Start Date  ICMJE March 2015
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2018)
  • 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.
  • 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).
  • 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).
Original Primary Outcome Measures  ICMJE
 (submitted: January 30, 2015)
Pulmonary safety within the CVT-301 treated patients, assessed by spirometry (forced expiratory volume in 1 second [FEV1] and FEV1/forced vital capacity [FVC] ratio) [ Time Frame: Over a 12-month period ]
Assessed by spirometry (forced expiratory volume in 1 second [FEV1] and FEV1/forced vital capacity [FVC] ratio).
Change History Complete list of historical versions of study NCT02352363 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2018)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2015)
  • Pulmonary safety within the observational (standard of care) cohort, assessed by spirometry FEV1 and FEV1/FVC ratio. [ Time Frame: Over a 12-month period ]
    Assessed by spirometry FEV1 and FEV1/FVC ratio.
  • Difference between the CVT-301-treated patients and the observational cohort on measures of pulmonary safety [ Time Frame: Over a 12-month period ]
  • Safety of CVT-301 measured by the number of patients with Adverse Events (AEs) [ Time Frame: Over a 12-month period ]
  • Effects of CVT-301 in the Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 motor score from pre-dose up to 60 minutes following treatment of patients experiencing an OFF episode in the clinic [ Time Frame: Time points up to and at 12 months ]
  • Effects of CVT-301 in the UPDRS item 23 (Finger Taps) and UPDRS item 31 (Body Bradykinesia and Hypokinesia) from pre-dose to 10 minutes following treatment of patients experiencing an OFF episode in the clinic [ Time Frame: Time points up to and at 12 months ]
  • Proportion of patients with a reduction in the UPDRS Part 3 motor score from pre-dose to post-dose after the initiation of CVT-301 treatment in clinic [ Time Frame: Time points up to and at 12 months ]
  • Occurrence and severity of examiner-rated dyskinesia following CVT-301 treatment of patients experiencing an OFF episode in the clinic [ Time Frame: Time points up to and at 12 months ]
  • Proportion of patients achieving resolution of an OFF to an ON state within 60 minutes/ ON state at the end of the 60-minute observation period, after study drug is administered in the clinic [ Time Frame: Time points up to and at 12 months ]
  • Patient-reported total daily OFF time, total daily ON time without dyskinesia, total daily ON time with non-troublesome dyskinesia, and total daily ON time with troublesome dyskinesia after the initiation of CVT-301 treatment [ Time Frame: Time points up to and at 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: January 30, 2015)
Change from baseline on patient-reported effects after the initiation of CVT-301 treatment [ Time Frame: Screening (up to 35 days before entering treatment), time points up to and at 12 months ]
 
Descriptive Information
Brief Title  ICMJE Randomized Safety Study of CVT-301 Compared to an Observational Control Group
Official Title  ICMJE 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
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: 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
  • Other: Observational cohort
Study Arms  ICMJE
  • 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.
    Intervention: Drug: CVT-301
  • 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.
    Intervention: Other: Observational cohort
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: May 25, 2017)
408
Original Estimated Enrollment  ICMJE
 (submitted: January 30, 2015)
365
Actual Study Completion Date  ICMJE May 2017
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 85 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 Austria,   Belgium,   Czechia,   France,   Germany,   Hungary,   Israel,   Netherlands,   Poland,   Romania,   Serbia,   Spain,   United Kingdom,   United States
Removed Location Countries Czech Republic,   Italy
 
Administrative Information
NCT Number  ICMJE NCT02352363
Other Study ID Numbers  ICMJE CVT-301-005
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 May 2019

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