Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
142 participants
INTERVENTIONAL
2014-04-21
2017-04-28
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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SPARC 1103 low dose
The subjects will receive SPARC 1103 low dose
SPARC1103 low dose
once daily
SPARC1103 high dose
The subjects will receive SPARC1103 high dose
SPARC1103 high dose
once daily
SPARC Placebo
The subjects will receive SPARC Placebo
SPARC Placebo
Interventions
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SPARC1103 low dose
once daily
SPARC1103 high dose
once daily
SPARC Placebo
Eligibility Criteria
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Inclusion Criteria
* Willing to sign the informed consent form
* Women of child bearing potential willing to practice an acceptable method of birth control
* Known history of spasticity due to MS
Exclusion Criteria
* Unable to comply with trial procedures in the opinion of the Investigator
* Concomitant neurologic conditions causing spasticity
* Any medical condition, including psychiatric disease or epilepsy, which would interfere with the interpretation of the trial results
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 4
Long Beach, California, United States
SPARC Site 6
San Diego, California, United States
SPARC Site 10
Aurora, Colorado, United States
SPARC Site 2
Jacksonville, Florida, United States
SPARC Site 15
Miami, Florida, United States
SPARC Site 7
Miami Springs, Florida, United States
SPARC Site 5
Orlando, Florida, United States
SPARC Site 13
Tampa, Florida, United States
SPARC Site 11
Kansas City, Kansas, United States
SPARC Site 3
Lenexa, Kansas, United States
SPARC Site 1
Bingham Farms, Michigan, United States
SPARC Site 14
Albuquerque, New Mexico, United States
SPARC Site 9
Charlotte, North Carolina, United States
SPARC Site 8
Cleveland, Ohio, United States
SPARC Site 12
Richland, Washington, United States
SPARC Site 18
Moscow, , Russia
SPARC Site 17
Nizhny Novgorod, , Russia
SPARC Site 20
Samara, , Russia
SPARC Site 19
Smolensk, , Russia
SPARC Site 16
Ufa, , Russia
SPARC Site 22
Dnipro, , Ukraine
SPARC Site 21
Ivano-Frankivsk, , Ukraine
SPARC Site 23
Lviv, , Ukraine
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CLR_11_03
Identifier Type: -
Identifier Source: org_study_id
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