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

May 23, 2019 updated by: Acorda Therapeutics

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™)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

351

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A5A5
        • Acorda Site #5103
      • Ottawa, Ontario, Canada, K1Y4E9
        • Acorda Site #5104
      • Toronto, Ontario, Canada, M5T2S8
        • Acorda Site #5105
  • Czechia
      • Prague, Czechia, 10000
        • Acorda Site #5201
      • Prague, Czechia, 14000
        • Acorda Site #5203
  • Poland
      • Katowice, Poland, 40588
        • Acorda Site #5304
      • Krakow, Poland, 30510
        • Acorda Site #5303
      • Kraków, Poland, 30349
        • Acorda Site #5306
      • Kraków, Poland, 31505
        • Acorda Site #5307
      • Lodz, Poland, 90130
        • Acorda Site #5302
      • Warsaw, Poland, 00453
        • Acorda Site #5308
      • Warsaw, Poland, 01868
        • Acorda Site #5301
      • Zaspa, Poland, 80462
        • Acorda Site #5305
  • Spain
      • Barcelona, Spain, 08026
        • Acorda Site #5404
      • Barcelona, Spain, 08035
        • Acorda Site #5406
      • Madrid, Spain, 28006
        • Acorda Site #5405
      • San Sebastián, Spain, 20009
        • Acorda Site #5403
      • Sant Cugat Del Vallès, Spain, 08190
        • Acorda Site #5401
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Acorda Site #5407
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Acorda Site #5020
    • California
      • Fresno, California, United States, 93710
        • Acorda Site #5042
      • Fullerton, California, United States, 92835
        • Acorda Site #5064
      • Loma Linda, California, United States, 92354
        • Acorda Site #5035
      • Long Beach, California, United States, 90806
        • Acorda Site #5027
      • Los Angeles, California, United States, 90033
        • Acorda Site #5037
      • Pasadena, California, United States, 91105
        • Acorda Site #5070
      • Reseda, California, United States, 91335
        • Acorda Site #5047
      • Santa Ana, California, United States, 92705
        • Acorda Site #5068
      • Torrance, California, United States, 90505
        • Acorda Site #5069
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Acorda Site #5052
    • Florida
      • Atlantis, Florida, United States, 33462
        • Acorda Site #5046
      • Aventura, Florida, United States, 33180
        • Acorda Site #5053
      • Boca Raton, Florida, United States, 33486
        • Acorda Site #5013
      • Jacksonville, Florida, United States, 32209
        • Acorda Site #5016
      • Maitland, Florida, United States, 32751
        • Acorda Site #5071
      • Orlando, Florida, United States, 32806
        • Acorda Site #5044
      • Palm Beach Gardens, Florida, United States, 33410
        • Acorda Site #5060
      • Port Charlotte, Florida, United States, 33952
        • Acorda Site #5001
      • Saint Petersburg, Florida, United States, 33713
        • Acorda Site #5065
      • Tampa, Florida, United States, 33613
        • Acorda Site #5012
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Acorda Site #5040
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Acorda Site #5025
      • Chicago, Illinois, United States, 60612
        • Acorda Site #5030
      • Elk Grove Village, Illinois, United States, 60007
        • Acorda Site #5011
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Acorda Site #5003
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70810
        • Acorda Site #5067
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Acorda Site #5057
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Acorda Site #5056
      • Boston, Massachusetts, United States, 02118
        • Acorda Site #5018
    • Michigan
      • Bingham Farms, Michigan, United States, 48025
        • Acorda Site #5002
      • West Bloomfield, Michigan, United States, 48322
        • Acorda Site #5014
    • Minnesota
      • Golden Valley, Minnesota, United States, 55427
        • Acorda Site #5041
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Acorda Site #5006
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Acorda Site #5023
    • New York
      • Albany, New York, United States, 12208
        • Acorda Site #5028
      • Brooklyn, New York, United States, 11203
        • Acorda Site #5039
      • New York, New York, United States, 10016
        • Acorda Site #5031
      • New York, New York, United States, 10029
        • Acorda Site #5032
      • New York, New York, United States, 10032
        • Acorda Site #5004
      • Syracuse, New York, United States, 13210
        • Acorda Site #5038
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Acorda Site #5048
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Acorda Site #5005
      • Norwood, Ohio, United States, 45212
        • Acorda Site #5050
    • Oregon
      • Portland, Oregon, United States, 97239
        • Acorda Site #5062
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Acorda Site #5036
      • Philadelphia, Pennsylvania, United States, 19107
        • Acorda Site #5010
      • Willow Grove, Pennsylvania, United States, 19090
        • Acorda Site #5058
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Acorda Site #5022
    • Tennessee
      • Nashville, Tennessee, United States, 372322551
        • Acorda Site #5029
    • Texas
      • Houston, Texas, United States, 77030
        • Acorda Site #5019
      • Houston, Texas, United States, 77030
        • Acorda Site #5045
    • Virginia
      • Henrico, Virginia, United States, 23226
        • Acorda Site #5049
      • Virginia Beach, Virginia, United States, 23456
        • Acorda Site #5059
    • Washington
      • Kirkland, Washington, United States, 98034
        • Acorda Site #5051

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Low Dose
Other Names:
  • 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 High Dose
Other Names:
  • Inhaled levodopa
Placebo Comparator: Placebo
Capsules of inhalation-grade lactose used up to 5 times/day for OFF episodes for 3 months duration.
Other: Placebo
Other Names:
  • Inhalation-grade lactose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Unified Parkinson's Disease Rating Scale (UPDRS) Part III
Time Frame: 30 minutes post-dose at week 12
Primary Efficacy Analysis: Change from Predose in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at 30 Minutes post-dose at Week 12 for CVT-301 High Dose versus Placebo (ITT Population). UPDRS Part III ranges from 0 minimum to 86 maximum, with lower scores indicating better movement. Units on a scale.
30 minutes post-dose at week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Patients Achieving Resolution of an OFF to an ON State Within 60 Minutes.
Time Frame: at week 12
Examiner-assessed observation - Subject Achieving Resolution of an OFF to and ON state within 60 Minutes at TV4 - Observed
at week 12
UPDRS Part III Motor Score at 20 Minutes
Time Frame: at week 12
Change from Predose in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at 20 Minutes post-dose at Week 12 for CVT-301 High Dose versus Placebo (ITT Population) and CVT 301 Low Dose versus Placebo. UPDRS Part III ranges from 0 minimum to 86 maximum, with lower scores indicating better movement. Units on a scale.
at week 12
Proportion of Subjects Who Improved PGIC With CVT-301 vs. Placebo at Week 12
Time Frame: week 12
Patient Global impression of change at treatment visit 4 (week 12) by improvement category. Seven point Likert scale ranging from 1= much worse to 7= much better.
week 12
UPDRS Part III at 10 Min.
Time Frame: week 12
Change from Predose in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at 10 Minutes post-dose at Week 12 for CVT-301 High Dose versus Placebo (ITT Population). UPDRS Part III ranges from 0 minimum to 86 maximum, with lower scores indicating better movement. Units on a scale.
week 12
PD Patient Diary
Time Frame: post week 12
Change in total daily OFF times for 3 consecutive days prior to week 12 visit compared to 3 consecutive days prior to baseline visit. Participants recorded On or Off state in 30 minute intervals during waking hours.
post week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acorda Therapeutics

Investigators

  • Study Director: Charles Oh, MD, Acorda Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

September 11, 2014

First Submitted That Met QC Criteria

September 11, 2014

First Posted (Estimate)

September 15, 2014

Study Record Updates

Last Update Posted (Actual)

May 28, 2019

Last Update Submitted That Met QC Criteria

May 23, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CVT-301-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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