We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 11 of 53 for:    Acorda

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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02242487
First Posted: September 17, 2014
Last Update Posted: July 2, 2017
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.
Information provided by (Responsible Party):
Acorda Therapeutics
  Purpose
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, CVT-301-009 and CVT-301-005 (observational arm completers), as well as 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
Intervention Model: Parallel Assignment
Masking: None (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 ]
    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 ]
    Adverse experiences, ECGs, vital signs, clinical laboratory evaluation, pulmonary function using DLco, scales to evaluate suicidality, day time sleepiness, and impulse control disorders

  • Proportion of patients achieving resolution of an OFF to an ON state within 60 minutes. [ Time Frame: up to 12 months ]
    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 ]
    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 ]
    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 ]
    PDQ-39


Enrollment: 325
Study Start Date: March 2015
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years to 86 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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): NCT02242487


  Show 74 Study Locations
Sponsors and Collaborators
Acorda Therapeutics
Investigators
Study Director: Charles Oh, MD Acorda Therapeutics
  More Information

Additional Information:
Responsible Party: Acorda Therapeutics
ClinicalTrials.gov Identifier: NCT02242487     History of Changes
Other Study ID Numbers: CVT-301-004E
First Submitted: September 15, 2014
First Posted: September 17, 2014
Last Update Posted: July 2, 2017
Last Verified: February 2017

Keywords provided by Acorda Therapeutics:
Parkinson's Disease
Motor fluctuations
levodopa
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
Levodopa
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs