Efficacy and Safety of SPARC0921 in Subjects With Spasticity
NCT ID: NCT01457352
Last Updated: 2019-06-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
392 participants
INTERVENTIONAL
2012-11-14
2017-08-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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SPARC0921
SPARC0921
Placebo0921
Placebo0921
Interventions
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SPARC0921
Placebo0921
Eligibility Criteria
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Inclusion Criteria
* Able and willing to comply with the protocol, including availability for a scheduled clinic visits
* Willingness and giving of written informed consent
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Sun Pharma Advanced Research Company Limited
INDUSTRY
Responsible Party
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Locations
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SPARC site 6
Gilbert, Arizona, United States
SPARC Site 40
Phoenix, Arizona, United States
SPARC Site 36
Costa Mesa, California, United States
SPARC Site 20
Newport Beach, California, United States
SPARC Site 38
Basalt, Colorado, United States
SPARC Site 21
Denver, Colorado, United States
SPARC Site 9
Derby, Connecticut, United States
SPARC Site 57
Hartford, Connecticut, United States
SPARC Site 10
New London, Connecticut, United States
SPARC Site 60
Washington D.C., District of Columbia, United States
SPARC Site 15
Bradenton, Florida, United States
SPARC Site 54
Jacksonville, Florida, United States
SPARC Site 41
Maitland, Florida, United States
SPARC Site 70
Miami, Florida, United States
SPARC Site 8
Ormond Beach, Florida, United States
SPARC Site 17
Port Charlotte, Florida, United States
SPARC Site 19
Sarasota, Florida, United States
SPARC Site 31
Sunrise, Florida, United States
SPARC Site 39
Tampa, Florida, United States
SPARC Site 65
Tampa, Florida, United States
SPARC Site 51
Lenexa, Kansas, United States
SPARC Site 30
Overland Park, Kansas, United States
SPARC Site 50
Louisville, Kentucky, United States
SPARC Site 42
Alexandria, Louisiana, United States
SPARC Site 27
Baton Rouge, Louisiana, United States
SPARC Site 73
New Orleans, Louisiana, United States
SPARC Site 35
Foxborough, Massachusetts, United States
SPARC Site 23
Springfield, Massachusetts, United States
SPARC Site 32
Clinton Township, Michigan, United States
SPARC Site 64
Detroit, Michigan, United States
SPARC Site 25
Golden Valley, Minnesota, United States
SPARC Site 5
Henderson, Nevada, United States
SPARC site 34
Flemington, New Jersey, United States
SPARC Site 55
Stratford, New Jersey, United States
SPARC Site 22
Albuquerque, New Mexico, United States
SPARC Site 49
Rochester, New York, United States
SPARC Site 45
Charlotte, North Carolina, United States
SPARC Site 4
Charlotte, North Carolina, United States
SPARC Site 24
Greensboro, North Carolina, United States
SPARC Site 2
Winston-Salem, North Carolina, United States
SPARC Site 75
Winston-Salem, North Carolina, United States
SPARC Site 16
Akron, Ohio, United States
SPARC Site 33
Centerville, Ohio, United States
SPARC Site 56
Columbus, Ohio, United States
SPARC Site 12
Eugene, Oregon, United States
SPARC Site 44
Springfield, Oregon, United States
SPARC Site 68
Abington, Pennsylvania, United States
SPARC Site 29
Old Point Station, South Carolina, United States
SPARC Site 7
Austin, Texas, United States
SPARC Site 71
Dallas, Texas, United States
SPARC Site 43
Houston, Texas, United States
SPARC Site 13
Salt Lake City, Utah, United States
SPARC Site 26
Tacoma, Washington, United States
SPARC Site 74
Huntington, West Virginia, United States
SPARC Site 69
Milwaukee, Wisconsin, United States
SPARC Site 67
Waukesha, Wisconsin, United States
SPARC Site 77
Dresden, , Germany
SPARC Site 76
Erbach im Odenwald, , Germany
SPARC Site 79
Teupitz, , Germany
SPARC Site 78
Westerstede, , Germany
SPARC Site 82
Budapest, , Hungary
SPARC site 83
Budapest, , Hungary
SPARC Site 81
Eger, , Hungary
SPARC Site 80
Esztergom, , Hungary
SPARC Site 87
Moscow, , Russia
SPARC Site 86
Novosibirsk, , Russia
SPARC Site 85
Saint Petersburg, , Russia
SPARC Site 84
Sestroretsk, , Russia
SPARC Site 88
Stavropol, , Russia
SPARC Site 90
Dnipropetrovsk, , Ukraine
SPARC Site 92
Lviv, , Ukraine
SPARC Site 91
Poltava, , Ukraine
SPARC Site 89
Zaporozh’ye, , Ukraine
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CLR_09_21
Identifier Type: -
Identifier Source: org_study_id
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