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Trial record 1 of 1 for:    SPAN-PD
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Efficacy and Safety Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes (SPAN-PD™)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02240030
First Posted: September 15, 2014
Last Update Posted: January 25, 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 randomized, multicenter, placebo-controlled, double-blind study will evaluate the efficacy and safety of inhaled CVT 301 compared with placebo in PD patients experiencing motor response fluctuations (OFF phenomena) as an outpatient (i.e., at home) and in the clinic.

Patients who successfully complete this study will be eligible to enroll into a 12 month treatment extension (CVT-301-004E) study .


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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Investigating the Efficacy and Safety of CVT 301 (Levodopa Inhalation Powder) in Parkinson's Disease Patients With Motor Response Fluctuations (OFF Phenomena) (SPAN-PD™)

Resource links provided by NLM:


Further study details as provided by Acorda Therapeutics:

Primary Outcome Measures:
  • Change from pre-dose in Unified Parkinson's Disease Rating Scale (UPDRS) Part III motor score at 30 minutes following treatment of patients experiencing an OFF episode [ Time Frame: at week 12 ]

Secondary Outcome Measures:
  • Proportion of patients achieving resolution of an OFF to an ON state within 60 minutes. [ Time Frame: at week 12 ]
    examiner-assessed observation

  • Change from pre-dose in UPDRS Part III motor score at 10 and 20 minutes following treatment of patients experiencing an OFF episode [ Time Frame: at week 12 ]
  • Safety (including pulmonary safety) and tolerability of CVT-301. [ Time Frame: change from baseline through 3 months duration of outpatient use ]
    Adverse experiences, ECGs, vital signs, clinical laboratory evaluation, pulmonary function using spirometry and DLco, scales to evaluate suicidality, day time sleepiness, and impulse control disorders

  • Total daily OFF time and daily ON time ± dyskinesia (troublesome/nontroublesome) [ Time Frame: change from baseline through 3 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 to 3 months duration of outpatient use ]
    Schwab & England Activities of Daily Living,UPDRS Part 2, PDQ-39, PGI-C, PHQ-9


Enrollment: 351
Study Start Date: November 2014
Study Completion Date: December 2016
Primary Completion Date: December 2016 (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 3 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 3 months duration
Drug: CVT-301
Other Name: Inhaled levodopa
Placebo Comparator: Placebo
Capsules of inhalation-grade lactose used up to 5 times/day for OFF episodes for 3 months duration.
Drug: CVT-301
Other Name: Inhaled levodopa

  Eligibility

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
Criteria

Inclusion Criteria:

  • Idiopathic Parkinson's Disease (PD) diagnosed between the ages of 30 and 85 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 LD dose <1600 mg/day;
  • Able to perform a spirometry maneuver in the ON and OFF states;
  • Normal cognition confirmed by 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 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): NCT02240030


  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: NCT02240030     History of Changes
Other Study ID Numbers: CVT-301-004
First Submitted: September 11, 2014
First Posted: September 15, 2014
Last Update Posted: January 25, 2017
Last Verified: January 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