Efficacy and Safety of SPARC0921 in Subjects With Spasticity
- Registration Number
- NCT01457352
- Lead Sponsor
- Sun Pharma Advanced Research Company Limited
- Brief Summary
The purpose of this study is to assess whether SPARC0921 demonstrate efficacy and safety in the treatment of spasticity.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 392
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo0921 Placebo0921 - SPARC0921 SPARC0921 -
- Primary Outcome Measures
Name Time Method Treatment Failure Rate Week 22 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
Name Time Method Severity of Spasticity Assessed by Subject Global Impression Severity Scale Week 22 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
Trial Locations
- Locations (73)
SPARC Site 56
🇺🇸Columbus, Ohio, United States
SPARC Site 17
🇺🇸Port Charlotte, Florida, United States
SPARC Site 36
🇺🇸Costa Mesa, California, United States
SPARC Site 20
🇺🇸Newport Beach, California, United States
SPARC Site 15
🇺🇸Bradenton, Florida, United States
SPARC Site 19
🇺🇸Sarasota, Florida, United States
SPARC Site 30
🇺🇸Overland Park, Kansas, United States
SPARC Site 76
🇩🇪Erbach, Germany
SPARC Site 43
🇺🇸Houston, Texas, United States
SPARC site 6
🇺🇸Gilbert, Arizona, United States
SPARC Site 70
🇺🇸Miami, Florida, United States
SPARC Site 64
🇺🇸Detroit, Michigan, United States
SPARC Site 13
🇺🇸Salt Lake City, Utah, United States
SPARC Site 57
🇺🇸Hartford, Connecticut, United States
SPARC Site 10
🇺🇸New London, Connecticut, United States
SPARC Site 60
🇺🇸Washington, District of Columbia, United States
SPARC Site 9
🇺🇸Derby, Connecticut, United States
SPARC site 83
🇭🇺Budapest, Hungary
SPARC Site 40
🇺🇸Phoenix, Arizona, United States
SPARC Site 29
🇺🇸Indian Land, South Carolina, United States
SPARC Site 81
🇭🇺Eger, Hungary
SPARC Site 27
🇺🇸Baton Rouge, Louisiana, United States
SPARC Site 86
🇷🇺Novosibirsk, Russian Federation
SPARC Site 84
🇷🇺Sestroretsk, Russian Federation
SPARC Site 55
🇺🇸Stratford, New Jersey, United States
SPARC Site 73
🇺🇸New Orleans, Louisiana, United States
SPARC Site 85
🇷🇺Saint Petersburg, Russian Federation
SPARC Site 74
🇺🇸Huntington, West Virginia, United States
SPARC Site 87
🇷🇺Moscow, Russian Federation
SPARC Site 91
🇺🇦Poltava, Ukraine
SPARC Site 89
🇺🇦Zaporozh'ye, Ukraine
SPARC Site 21
🇺🇸Denver, Colorado, United States
SPARC Site 38
🇺🇸Basalt, Colorado, United States
SPARC Site 54
🇺🇸Jacksonville, Florida, United States
SPARC Site 41
🇺🇸Maitland, Florida, United States
SPARC Site 31
🇺🇸Sunrise, Florida, United States
SPARC Site 39
🇺🇸Tampa, Florida, United States
SPARC Site 51
🇺🇸Lenexa, Kansas, United States
SPARC Site 65
🇺🇸Tampa, Florida, United States
SPARC Site 50
🇺🇸Louisville, Kentucky, United States
SPARC Site 42
🇺🇸Alexandria, Louisiana, United States
SPARC Site 23
🇺🇸Springfield, Massachusetts, United States
SPARC Site 35
🇺🇸Foxboro, Massachusetts, United States
SPARC Site 32
🇺🇸Clinton Township, Michigan, United States
SPARC Site 5
🇺🇸Henderson, Nevada, United States
SPARC Site 25
🇺🇸Golden Valley, Minnesota, United States
SPARC site 34
🇺🇸Flemington, New Jersey, United States
SPARC Site 49
🇺🇸Rochester, New York, United States
SPARC Site 45
🇺🇸Charlotte, North Carolina, United States
SPARC Site 22
🇺🇸Albuquerque, New Mexico, 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 12
🇺🇸Eugene, Oregon, United States
SPARC Site 26
🇺🇸Tacoma, Washington, United States
SPARC Site 7
🇺🇸Austin, Texas, United States
SPARC Site 68
🇺🇸Abington, Pennsylvania, United States
SPARC Site 44
🇺🇸Springfield, Oregon, United States
SPARC Site 71
🇺🇸Dallas, Texas, United States
SPARC Site 67
🇺🇸Waukesha, Wisconsin, United States
SPARC Site 69
🇺🇸Milwaukee, Wisconsin, United States
SPARC Site 78
🇩🇪Westerstede, Germany
SPARC Site 77
🇩🇪Dresden, Germany
SPARC Site 79
🇩🇪Teupitz, Germany
SPARC Site 82
🇭🇺Budapest, Hungary
SPARC Site 80
🇭🇺Esztergom, Hungary
SPARC Site 88
🇷🇺Stavropol', Russian Federation
SPARC Site 90
🇺🇦Dnipropetrovsk, Ukraine
SPARC Site 92
🇺🇦L'viv, Ukraine
SPARC Site 8
🇺🇸Ormond Beach, Florida, United States