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

Primary Purpose

Idiopathic Parkinson's Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
CVT-301 Low Dose
CVT-301 High Dose
Placebo
Sponsored by
Acorda Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Parkinson's Disease focused on measuring Parkinson's Disease, Motor fluctuations, levodopa, inhaled drugs, OFF episodes

Eligibility Criteria

30 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Acorda Site #5020
  • Acorda Site #5042
  • Acorda Site #5064
  • Acorda Site #5035
  • Acorda Site #5027
  • Acorda Site #5037
  • Acorda Site #5070
  • Acorda Site #5047
  • Acorda Site #5068
  • Acorda Site #5069
  • Acorda Site #5052
  • Acorda Site #5046
  • Acorda Site #5053
  • Acorda Site #5013
  • Acorda Site #5016
  • Acorda Site #5071
  • Acorda Site #5044
  • Acorda Site #5060
  • Acorda Site #5001
  • Acorda Site #5065
  • Acorda Site #5012
  • Acorda Site #5040
  • Acorda Site #5025
  • Acorda Site #5030
  • Acorda Site #5011
  • Acorda Site #5003
  • Acorda Site #5067
  • Acorda Site #5057
  • Acorda Site #5056
  • Acorda Site #5018
  • Acorda Site #5002
  • Acorda Site #5014
  • Acorda Site #5041
  • Acorda Site #5006
  • Acorda Site #5023
  • Acorda Site #5028
  • Acorda Site #5039
  • Acorda Site #5031
  • Acorda Site #5032
  • Acorda Site #5004
  • Acorda Site #5038
  • Acorda Site #5048
  • Acorda Site #5005
  • Acorda Site #5050
  • Acorda Site #5062
  • Acorda Site #5036
  • Acorda Site #5010
  • Acorda Site #5058
  • Acorda Site #5022
  • Acorda Site #5029
  • Acorda Site #5019
  • Acorda Site #5045
  • Acorda Site #5049
  • Acorda Site #5059
  • Acorda Site #5051
  • Acorda Site #5103
  • Acorda Site #5104
  • Acorda Site #5105
  • Acorda Site #5201
  • Acorda Site #5203
  • Acorda Site #5304
  • Acorda Site #5303
  • Acorda Site #5306
  • Acorda Site #5307
  • Acorda Site #5302
  • Acorda Site #5308
  • Acorda Site #5301
  • Acorda Site #5305
  • Acorda Site #5407
  • Acorda Site #5404
  • Acorda Site #5406
  • Acorda Site #5405
  • Acorda Site #5403
  • Acorda Site #5401

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

CVT-301 Low Dose

CVT-301 High Dose

Placebo

Arm Description

Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration

Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration

Capsules of inhalation-grade lactose used up to 5 times/day for OFF episodes for 3 months duration.

Outcomes

Primary Outcome Measures

Unified Parkinson's Disease Rating Scale (UPDRS) Part III
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

Proportion of Patients Achieving Resolution of an OFF to an ON State Within 60 Minutes.
Examiner-assessed observation - Subject Achieving Resolution of an OFF to and ON state within 60 Minutes at TV4 - Observed
UPDRS Part III Motor Score at 20 Minutes
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.
Proportion of Subjects Who Improved PGIC With CVT-301 vs. Placebo at 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.
UPDRS Part III at 10 Min.
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.
PD Patient Diary
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.

Full Information

First Posted
September 11, 2014
Last Updated
May 23, 2019
Sponsor
Acorda Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT02240030
Brief Title
Efficacy and Safety Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes
Acronym
SPAN-PD™
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 Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acorda Therapeutics

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Parkinson's Disease
Keywords
Parkinson's Disease, Motor fluctuations, levodopa, inhaled drugs, OFF episodes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
351 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CVT-301 Low Dose
Arm Type
Experimental
Arm Description
Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration
Arm Title
CVT-301 High Dose
Arm Type
Experimental
Arm Description
Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Capsules of inhalation-grade lactose used up to 5 times/day for OFF episodes for 3 months duration.
Intervention Type
Drug
Intervention Name(s)
CVT-301 Low Dose
Other Intervention Name(s)
Inhaled levodopa
Intervention Type
Drug
Intervention Name(s)
CVT-301 High Dose
Other Intervention Name(s)
Inhaled levodopa
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Inhalation-grade lactose
Primary Outcome Measure Information:
Title
Unified Parkinson's Disease Rating Scale (UPDRS) Part III
Description
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.
Time Frame
30 minutes post-dose at week 12
Secondary Outcome Measure Information:
Title
Proportion of Patients Achieving Resolution of an OFF to an ON State Within 60 Minutes.
Description
Examiner-assessed observation - Subject Achieving Resolution of an OFF to and ON state within 60 Minutes at TV4 - Observed
Time Frame
at week 12
Title
UPDRS Part III Motor Score at 20 Minutes
Description
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.
Time Frame
at week 12
Title
Proportion of Subjects Who Improved PGIC With CVT-301 vs. Placebo at Week 12
Description
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.
Time Frame
week 12
Title
UPDRS Part III at 10 Min.
Description
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.
Time Frame
week 12
Title
PD Patient Diary
Description
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.
Time Frame
post week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Oh, MD
Organizational Affiliation
Acorda Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Acorda Site #5020
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Acorda Site #5042
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
Facility Name
Acorda Site #5064
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Acorda Site #5035
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Acorda Site #5027
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Acorda Site #5037
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Acorda Site #5070
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Acorda Site #5047
City
Reseda
State/Province
California
ZIP/Postal Code
91335
Country
United States
Facility Name
Acorda Site #5068
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Acorda Site #5069
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Acorda Site #5052
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Acorda Site #5046
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
Acorda Site #5053
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Acorda Site #5013
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Acorda Site #5016
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Acorda Site #5071
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Acorda Site #5044
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Acorda Site #5060
City
Palm Beach Gardens
State/Province
Florida
ZIP/Postal Code
33410
Country
United States
Facility Name
Acorda Site #5001
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
Acorda Site #5065
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33713
Country
United States
Facility Name
Acorda Site #5012
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Acorda Site #5040
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
Acorda Site #5025
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Acorda Site #5030
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Acorda Site #5011
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Facility Name
Acorda Site #5003
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Acorda Site #5067
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70810
Country
United States
Facility Name
Acorda Site #5057
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Acorda Site #5056
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Acorda Site #5018
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Acorda Site #5002
City
Bingham Farms
State/Province
Michigan
ZIP/Postal Code
48025
Country
United States
Facility Name
Acorda Site #5014
City
West Bloomfield
State/Province
Michigan
ZIP/Postal Code
48322
Country
United States
Facility Name
Acorda Site #5041
City
Golden Valley
State/Province
Minnesota
ZIP/Postal Code
55427
Country
United States
Facility Name
Acorda Site #5006
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Acorda Site #5023
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Acorda Site #5028
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Acorda Site #5039
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Acorda Site #5031
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Acorda Site #5032
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Acorda Site #5004
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Acorda Site #5038
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Acorda Site #5048
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Acorda Site #5005
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Acorda Site #5050
City
Norwood
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
Acorda Site #5062
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Acorda Site #5036
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Acorda Site #5010
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Acorda Site #5058
City
Willow Grove
State/Province
Pennsylvania
ZIP/Postal Code
19090
Country
United States
Facility Name
Acorda Site #5022
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Acorda Site #5029
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
372322551
Country
United States
Facility Name
Acorda Site #5019
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Acorda Site #5045
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Acorda Site #5049
City
Henrico
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
Facility Name
Acorda Site #5059
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23456
Country
United States
Facility Name
Acorda Site #5051
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States
Facility Name
Acorda Site #5103
City
London
State/Province
Ontario
ZIP/Postal Code
N6A5A5
Country
Canada
Facility Name
Acorda Site #5104
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y4E9
Country
Canada
Facility Name
Acorda Site #5105
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T2S8
Country
Canada
Facility Name
Acorda Site #5201
City
Prague
ZIP/Postal Code
10000
Country
Czechia
Facility Name
Acorda Site #5203
City
Prague
ZIP/Postal Code
14000
Country
Czechia
Facility Name
Acorda Site #5304
City
Katowice
ZIP/Postal Code
40588
Country
Poland
Facility Name
Acorda Site #5303
City
Krakow
ZIP/Postal Code
30510
Country
Poland
Facility Name
Acorda Site #5306
City
Kraków
ZIP/Postal Code
30349
Country
Poland
Facility Name
Acorda Site #5307
City
Kraków
ZIP/Postal Code
31505
Country
Poland
Facility Name
Acorda Site #5302
City
Lodz
ZIP/Postal Code
90130
Country
Poland
Facility Name
Acorda Site #5308
City
Warsaw
ZIP/Postal Code
00453
Country
Poland
Facility Name
Acorda Site #5301
City
Warsaw
ZIP/Postal Code
01868
Country
Poland
Facility Name
Acorda Site #5305
City
Zaspa
ZIP/Postal Code
80462
Country
Poland
Facility Name
Acorda Site #5407
City
Pamplona
State/Province
Navarre
ZIP/Postal Code
31008
Country
Spain
Facility Name
Acorda Site #5404
City
Barcelona
ZIP/Postal Code
08026
Country
Spain
Facility Name
Acorda Site #5406
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Acorda Site #5405
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Acorda Site #5403
City
San Sebastián
ZIP/Postal Code
20009
Country
Spain
Facility Name
Acorda Site #5401
City
Sant Cugat Del Vallès
ZIP/Postal Code
08190
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
30663606
Citation
LeWitt PA, Hauser RA, Pahwa R, Isaacson SH, Fernandez HH, Lew M, Saint-Hilaire M, Pourcher E, Lopez-Manzanares L, Waters C, Rudzinska M, Sedkov A, Batycky R, Oh C; SPAN-PD Study Investigators. Safety and efficacy of CVT-301 (levodopa inhalation powder) on motor function during off periods in patients with Parkinson's disease: a randomised, double-blind, placebo-controlled phase 3 trial. Lancet Neurol. 2019 Feb;18(2):145-154. doi: 10.1016/S1474-4422(18)30405-8. Erratum In: Lancet Neurol. 2019 Mar;18(3):e2.
Results Reference
derived
Links:
URL
http://cvt301.acordatrials.com/en/patient/?src=clinicaltrialsgov004
Description
Click here for more information about this study: CVT-301-004

Learn more about this trial

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

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