Safety Study of SPARC1104
- Conditions
- Spasticity
- Interventions
- Drug: SPARC1104 modified dose regimen IDrug: SPARC1104 modified dose regimen IIDrug: SPARC1104 modified dose regimen III
- Registration Number
- NCT01797185
- Lead Sponsor
- Sun Pharma Advanced Research Company Limited
- Brief Summary
Open-label, safety study of SPARC1104 in subjects with spasticity due to multiple sclerosis
- Detailed Description
Safety study of SPARC1104
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 375
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SPARC1104 group 1 SPARC1104 modified dose regimen I - SPARC1104 group 2 SPARC1104 modified dose regimen II - SPARC1104 group 3 SPARC1104 modified dose regimen III -
- Primary Outcome Measures
Name Time Method Number of Subjects With Adverse Events 52 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (50)
SPARC Site 11
🇺🇸Port Charlotte, Florida, United States
SPARC Site 24
🇺🇸Overland Park, Kansas, United States
SPARC Site 34
🇺🇸Phoenix, Arizona, United States
SPARC Site 58
🇺🇸Milwaukee, Wisconsin, United States
SPARC Site 59
🇺🇸Miami, Florida, United States
SPARC Site 54
🇺🇸Detroit, Michigan, United States
SPARC Site 37
🇺🇸Houston, Texas, United States
SPARC Site 30
🇺🇸Costa Mesa, California, United States
SPARC site 47
🇺🇸Hartford, Connecticut, United States
SPARC Site 16
🇺🇸Albuquerque, New Mexico, United States
SPARC Site 27
🇺🇸Centerville, Ohio, United States
SPARC Site 20
🇺🇸Tacoma, Washington, United States
SPARC Site 62
🇺🇸Huntington, West Virginia, United States
SPARC Site 52
🇺🇸White Plains, New York, United States
SPARC site 39
🇺🇸Charlotte, North Carolina, United States
SPARC Site 1
🇺🇸Tucson, Arizona, United States
SPARC site 4
🇺🇸Gilbert, Arizona, United States
SPARC Site 14
🇺🇸Newport Beach, California, United States
SPARC Site 7
🇺🇸Derby, Connecticut, United States
SPARC Site 32
🇺🇸Basalt, Colorado, United States
SPARC Site 50
🇺🇸Washington, District of Columbia, United States
SPARC Site 8
🇺🇸New London, Connecticut, United States
SPARC Site 35
🇺🇸Maitland, Florida, United States
SPARC Site 6
🇺🇸Ormond Beach, Florida, United States
SPARC Site 25
🇺🇸Sunrise, Florida, United States
SPARC Site 13
🇺🇸Sarasota, Florida, United States
SPARC site 45
🇺🇸Lenexa, Kansas, United States
SPARC Site 21
🇺🇸Baton Rouge, Louisiana, United States
SPARC Site 22
🇺🇸Fulton, Maryland, United States
SPARC Site 49
🇺🇸Baltimore, Maryland, United States
SPARC site 36
🇺🇸Alexandria, Louisiana, United States
SPARC Site 17
🇺🇸Springfield, Massachusetts, United States
SPARC Site 26
🇺🇸Clinton Township, Michigan, United States
SPARC Site 29
🇺🇸Foxboro, Massachusetts, United States
SPARC Site 43
🇺🇸Rochester, New York, United States
SPARC Site 28
🇺🇸Flemington, New Jersey, United States
SPARC Site 19
🇺🇸Golden Valley, Minnesota, United States
SPARC Site 18
🇺🇸Greensboro, North Carolina, United States
SPARC Site 57
🇺🇸Abington, Pennsylvania, United States
SPARC site 38
🇺🇸Springfield, Oregon, United States
SPARC site 10
🇺🇸Eugene, Oregon, United States
SPARC Site 23
🇺🇸Indian Land, South Carolina, United States
SPARC Site 60
🇺🇸Dallas, Texas, United States
SPARC Site 56
🇺🇸Waukesha, Wisconsin, United States
SPARC Site 44
🇺🇸Louisville, Kentucky, United States
SPARC Site 61
🇺🇸New Orleans, Louisiana, United States
SPARC Site 5
🇺🇸Austin, Texas, United States
SPARC Site 33
🇺🇸Tampa, Florida, United States
SPARC Site 55
🇺🇸Tampa, Florida, United States
SPARC Site 2
🇺🇸Winston-Salem, North Carolina, United States