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Efficacy and Safety of SPARC0921 in Subjects With Spasticity

Primary Purpose

Spasticity

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
SPARC0921
Placebo0921
Sponsored by
Sun Pharma Advanced Research Company Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spasticity focused on measuring spasticity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Men and women age 18 years and older
  • Able and willing to comply with the protocol, including availability for a scheduled clinic visits
  • Willingness and giving of written informed consent

Exclusion Criteria:

  • In relapse or history of unstable course over the prior 30 days prior to the Screening Visit
  • Concomitant neurologic conditions causing spasticity
  • Has received an investigational drug or device within 30 days that would interfere with the study goals prior to the Screening Visit
  • Unable to comply with study procedures in the opinion of the investigator

Sites / Locations

  • SPARC site 6
  • SPARC Site 40
  • SPARC Site 36
  • SPARC Site 20
  • SPARC Site 38
  • SPARC Site 21
  • SPARC Site 9
  • SPARC Site 57
  • SPARC Site 10
  • SPARC Site 60
  • SPARC Site 15
  • SPARC Site 54
  • SPARC Site 41
  • SPARC Site 70
  • SPARC Site 8
  • SPARC Site 17
  • SPARC Site 19
  • SPARC Site 31
  • SPARC Site 39
  • SPARC Site 65
  • SPARC Site 51
  • SPARC Site 30
  • SPARC Site 50
  • SPARC Site 42
  • SPARC Site 27
  • SPARC Site 73
  • SPARC Site 35
  • SPARC Site 23
  • SPARC Site 32
  • SPARC Site 64
  • SPARC Site 25
  • SPARC Site 5
  • SPARC site 34
  • SPARC Site 55
  • SPARC Site 22
  • SPARC Site 49
  • SPARC Site 45
  • SPARC Site 4
  • SPARC Site 24
  • SPARC Site 2
  • SPARC Site 75
  • SPARC Site 16
  • SPARC Site 33
  • SPARC Site 56
  • SPARC Site 12
  • SPARC Site 44
  • SPARC Site 68
  • SPARC Site 29
  • SPARC Site 7
  • SPARC Site 71
  • SPARC Site 43
  • SPARC Site 13
  • SPARC Site 26
  • SPARC Site 74
  • SPARC Site 69
  • SPARC Site 67
  • SPARC Site 77
  • SPARC Site 76
  • SPARC Site 79
  • SPARC Site 78
  • SPARC Site 82
  • SPARC site 83
  • SPARC Site 81
  • SPARC Site 80
  • SPARC Site 87
  • SPARC Site 86
  • SPARC Site 85
  • SPARC Site 84
  • SPARC Site 88
  • SPARC Site 90
  • SPARC Site 92
  • SPARC Site 91
  • SPARC Site 89

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SPARC0921

Placebo0921

Arm Description

Outcomes

Primary Outcome Measures

Treatment Failure Rate
Percentage of subjects who had treatment failure Clinical Global Impression of Change of ≥ 5 and at least one movement with ≥ 1 unit increase in modified Ashworth score from baseline. The modified Ashworth scale is a 6-point scale as follows: Minimum score of 0 (better outcome) = no increase in tone Maximum score of 4 (worst outcome) = affected part(s) rigid inflexion or extension. The clinician (other than the one performing the Modified Ashworth Scale assessment) rated his/her overall (global) impression of change in spasticity using the 7-point scale shown below: Minimum score of 1 (better outcome) = very much improved Maximum score of 7 (very much worse) = very much worse

Secondary Outcome Measures

Severity of Spasticity Assessed by Subject Global Impression Severity Scale
The subject was asked "Overall, how would you rate the severity of your spasticity over the past 24 hours?" The 7-point scale for Subject's global impression of severity assessment is as follows: minimum score of 1 = normal, no spasticity maximum score of 7 (worst outcome)= worst spasticity imaginable

Full Information

First Posted
October 17, 2011
Last Updated
June 16, 2019
Sponsor
Sun Pharma Advanced Research Company Limited
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1. Study Identification

Unique Protocol Identification Number
NCT01457352
Brief Title
Efficacy and Safety of SPARC0921 in Subjects With Spasticity
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
November 14, 2012 (Actual)
Primary Completion Date
August 25, 2017 (Actual)
Study Completion Date
August 25, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sun Pharma Advanced Research Company Limited

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to assess whether SPARC0921 demonstrate efficacy and safety in the treatment of spasticity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spasticity
Keywords
spasticity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
392 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SPARC0921
Arm Type
Experimental
Arm Title
Placebo0921
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
SPARC0921
Intervention Type
Drug
Intervention Name(s)
Placebo0921
Primary Outcome Measure Information:
Title
Treatment Failure Rate
Description
Percentage of subjects who had treatment failure Clinical Global Impression of Change of ≥ 5 and at least one movement with ≥ 1 unit increase in modified Ashworth score from baseline. The modified Ashworth scale is a 6-point scale as follows: Minimum score of 0 (better outcome) = no increase in tone Maximum score of 4 (worst outcome) = affected part(s) rigid inflexion or extension. The clinician (other than the one performing the Modified Ashworth Scale assessment) rated his/her overall (global) impression of change in spasticity using the 7-point scale shown below: Minimum score of 1 (better outcome) = very much improved Maximum score of 7 (very much worse) = very much worse
Time Frame
Week 22
Secondary Outcome Measure Information:
Title
Severity of Spasticity Assessed by Subject Global Impression Severity Scale
Description
The subject was asked "Overall, how would you rate the severity of your spasticity over the past 24 hours?" The 7-point scale for Subject's global impression of severity assessment is as follows: minimum score of 1 = normal, no spasticity maximum score of 7 (worst outcome)= worst spasticity imaginable
Time Frame
Week 22

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women age 18 years and older Able and willing to comply with the protocol, including availability for a scheduled clinic visits Willingness and giving of written informed consent Exclusion Criteria: In relapse or history of unstable course over the prior 30 days prior to the Screening Visit Concomitant neurologic conditions causing spasticity Has received an investigational drug or device within 30 days that would interfere with the study goals prior to the Screening Visit Unable to comply with study procedures in the opinion of the investigator
Facility Information:
Facility Name
SPARC site 6
City
Gilbert
State/Province
Arizona
Country
United States
Facility Name
SPARC Site 40
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
SPARC Site 36
City
Costa Mesa
State/Province
California
Country
United States
Facility Name
SPARC Site 20
City
Newport Beach
State/Province
California
Country
United States
Facility Name
SPARC Site 38
City
Basalt
State/Province
Colorado
Country
United States
Facility Name
SPARC Site 21
City
Denver
State/Province
Colorado
Country
United States
Facility Name
SPARC Site 9
City
Derby
State/Province
Connecticut
Country
United States
Facility Name
SPARC Site 57
City
Hartford
State/Province
Connecticut
Country
United States
Facility Name
SPARC Site 10
City
New London
State/Province
Connecticut
Country
United States
Facility Name
SPARC Site 60
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
SPARC Site 15
City
Bradenton
State/Province
Florida
Country
United States
Facility Name
SPARC Site 54
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
SPARC Site 41
City
Maitland
State/Province
Florida
Country
United States
Facility Name
SPARC Site 70
City
Miami
State/Province
Florida
Country
United States
Facility Name
SPARC Site 8
City
Ormond Beach
State/Province
Florida
Country
United States
Facility Name
SPARC Site 17
City
Port Charlotte
State/Province
Florida
Country
United States
Facility Name
SPARC Site 19
City
Sarasota
State/Province
Florida
Country
United States
Facility Name
SPARC Site 31
City
Sunrise
State/Province
Florida
Country
United States
Facility Name
SPARC Site 39
City
Tampa
State/Province
Florida
Country
United States
Facility Name
SPARC Site 65
City
Tampa
State/Province
Florida
Country
United States
Facility Name
SPARC Site 51
City
Lenexa
State/Province
Kansas
Country
United States
Facility Name
SPARC Site 30
City
Overland Park
State/Province
Kansas
Country
United States
Facility Name
SPARC Site 50
City
Louisville
State/Province
Kentucky
Country
United States
Facility Name
SPARC Site 42
City
Alexandria
State/Province
Louisiana
Country
United States
Facility Name
SPARC Site 27
City
Baton Rouge
State/Province
Louisiana
Country
United States
Facility Name
SPARC Site 73
City
New Orleans
State/Province
Louisiana
Country
United States
Facility Name
SPARC Site 35
City
Foxboro
State/Province
Massachusetts
Country
United States
Facility Name
SPARC Site 23
City
Springfield
State/Province
Massachusetts
Country
United States
Facility Name
SPARC Site 32
City
Clinton Township
State/Province
Michigan
Country
United States
Facility Name
SPARC Site 64
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
SPARC Site 25
City
Golden Valley
State/Province
Minnesota
Country
United States
Facility Name
SPARC Site 5
City
Henderson
State/Province
Nevada
Country
United States
Facility Name
SPARC site 34
City
Flemington
State/Province
New Jersey
Country
United States
Facility Name
SPARC Site 55
City
Stratford
State/Province
New Jersey
Country
United States
Facility Name
SPARC Site 22
City
Albuquerque
State/Province
New Mexico
Country
United States
Facility Name
SPARC Site 49
City
Rochester
State/Province
New York
Country
United States
Facility Name
SPARC Site 45
City
Charlotte
State/Province
North Carolina
Country
United States
Facility Name
SPARC Site 4
City
Charlotte
State/Province
North Carolina
Country
United States
Facility Name
SPARC Site 24
City
Greensboro
State/Province
North Carolina
Country
United States
Facility Name
SPARC Site 2
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
SPARC Site 75
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
SPARC Site 16
City
Akron
State/Province
Ohio
Country
United States
Facility Name
SPARC Site 33
City
Centerville
State/Province
Ohio
Country
United States
Facility Name
SPARC Site 56
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
SPARC Site 12
City
Eugene
State/Province
Oregon
Country
United States
Facility Name
SPARC Site 44
City
Springfield
State/Province
Oregon
Country
United States
Facility Name
SPARC Site 68
City
Abington
State/Province
Pennsylvania
Country
United States
Facility Name
SPARC Site 29
City
Indian Land
State/Province
South Carolina
Country
United States
Facility Name
SPARC Site 7
City
Austin
State/Province
Texas
Country
United States
Facility Name
SPARC Site 71
City
Dallas
State/Province
Texas
Country
United States
Facility Name
SPARC Site 43
City
Houston
State/Province
Texas
Country
United States
Facility Name
SPARC Site 13
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
SPARC Site 26
City
Tacoma
State/Province
Washington
Country
United States
Facility Name
SPARC Site 74
City
Huntington
State/Province
West Virginia
Country
United States
Facility Name
SPARC Site 69
City
Milwaukee
State/Province
Wisconsin
Country
United States
Facility Name
SPARC Site 67
City
Waukesha
State/Province
Wisconsin
Country
United States
Facility Name
SPARC Site 77
City
Dresden
Country
Germany
Facility Name
SPARC Site 76
City
Erbach
Country
Germany
Facility Name
SPARC Site 79
City
Teupitz
Country
Germany
Facility Name
SPARC Site 78
City
Westerstede
Country
Germany
Facility Name
SPARC Site 82
City
Budapest
Country
Hungary
Facility Name
SPARC site 83
City
Budapest
Country
Hungary
Facility Name
SPARC Site 81
City
Eger
Country
Hungary
Facility Name
SPARC Site 80
City
Esztergom
Country
Hungary
Facility Name
SPARC Site 87
City
Moscow
Country
Russian Federation
Facility Name
SPARC Site 86
City
Novosibirsk
Country
Russian Federation
Facility Name
SPARC Site 85
City
Saint Petersburg
Country
Russian Federation
Facility Name
SPARC Site 84
City
Sestroretsk
Country
Russian Federation
Facility Name
SPARC Site 88
City
Stavropol'
Country
Russian Federation
Facility Name
SPARC Site 90
City
Dnipropetrovsk
Country
Ukraine
Facility Name
SPARC Site 92
City
L'viv
Country
Ukraine
Facility Name
SPARC Site 91
City
Poltava
Country
Ukraine
Facility Name
SPARC Site 89
City
Zaporozh'ye
Country
Ukraine

12. IPD Sharing Statement

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Efficacy and Safety of SPARC0921 in Subjects With Spasticity

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