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

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ClinicalTrials.gov Identifier: NCT02240030
Recruitment Status : Completed
First Posted : September 15, 2014
Results First Posted : April 17, 2018
Last Update Posted : May 27, 2019
Sponsor:
Information provided by (Responsible Party):
Acorda Therapeutics

Brief Summary:

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 or disease Intervention/treatment Phase
Idiopathic Parkinson's Disease Drug: CVT-301 Low Dose Drug: CVT-301 High Dose Other: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 351 participants
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™)
Study Start Date : November 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Levodopa

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 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 High Dose
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.
Other: Placebo
Other Name: Inhalation-grade lactose




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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.



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Ages Eligible for Study:   30 Years to 85 Years   (Adult, Older Adult)
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.

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


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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Acorda Therapeutics
ClinicalTrials.gov Identifier: NCT02240030     History of Changes
Other Study ID Numbers: CVT-301-004
First Posted: September 15, 2014    Key Record Dates
Results First Posted: April 17, 2018
Last Update Posted: May 27, 2019
Last Verified: May 2019

Keywords provided by Acorda Therapeutics:
Parkinson's Disease
Motor fluctuations
levodopa
inhaled drugs
OFF episodes

Additional relevant MeSH terms:
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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