Clinical trial NCT01457352: Efficacy and Safety of SPARC0921 in Subjects With Spasticity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Spasticity
Keywords: spasticity
Lead sponsor: Sun Pharma Advanced Research Company Limited
Sponsor class: INDUSTRY
First posted: 2011-10-21
Enrollment: 392
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Treatment Failure Rate
timeFrame: Week 22
Secondary outcomes:
measure: Severity of Spasticity Assessed by Subject Global Impression Severity Scale
timeFrame: Week 22
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: SPARC site 6
state: Arizona
city: Phoenix
country: United States
facility: SPARC Site 40
state: Arizona
city: Costa Mesa
country: United States
facility: SPARC Site 36
state: California
city: Newport Beach
country: United States
facility: SPARC Site 20
state: California
city: Basalt
country: United States
facility: SPARC Site 38
state: Colorado
city: Denver
country: United States
facility: SPARC Site 21
state: Colorado
city: Derby
country: United States
facility: SPARC Site 9
state: Connecticut
city: Hartford
country: United States
facility: SPARC Site 57
state: Connecticut
city: New London
country: United States
facility: SPARC Site 10
state: Connecticut
city: Washington
country: United States
facility: SPARC Site 60
state: District of Columbia
city: Bradenton
country: United States
facility: SPARC Site 15
state: Florida
city: Jacksonville
country: United States
facility: SPARC Site 54
state: Florida
city: Maitland
country: United States
facility: SPARC Site 41
state: Florida
city: Miami
country: United States
facility: SPARC Site 70
state: Florida
city: Ormond Beach
country: United States
facility: SPARC Site 8
state: Florida
city: Port Charlotte
country: United States
facility: SPARC Site 17
state: Florida
city: Sarasota
country: United States
facility: SPARC Site 19
state: Florida
city: Sunrise
country: United States
facility: SPARC Site 31
state: Florida
city: Tampa
country: United States
facility: SPARC Site 39
state: Florida
city: Tampa
country: United States
facility: SPARC Site 65
state: Florida
city: Lenexa
country: United States
facility: SPARC Site 51
state: Kansas
city: Overland Park
country: United States
facility: SPARC Site 30
state: Kansas
city: Louisville
country: United States
facility: SPARC Site 50
state: Kentucky
city: Alexandria
country: United States
facility: SPARC Site 42
state: Louisiana
city: Baton Rouge
country: United States
facility: SPARC Site 27
state: Louisiana
city: New Orleans
country: United States
facility: SPARC Site 73
state: Louisiana
city: Foxboro
country: United States
facility: SPARC Site 35
state: Massachusetts
city: Springfield
country: United States
facility: SPARC Site 23
state: Massachusetts
city: Clinton Township
country: United States
facility: SPARC Site 32
state: Michigan
city: Detroit
country: United States
facility: SPARC Site 64
state: Michigan
city: Golden Valley
country: United States
facility: SPARC Site 25
state: Minnesota
city: Henderson
country: United States
facility: SPARC Site 5
state: Nevada
city: Flemington
country: United States
facility: SPARC site 34
state: New Jersey
city: Stratford
country: United States
facility: SPARC Site 55
state: New Jersey
city: Albuquerque
country: United States
facility: SPARC Site 22
state: New Mexico
city: Rochester
country: United States
facility: SPARC Site 49
state: New York
city: Charlotte
country: United States
facility: SPARC Site 45
state: North Carolina
city: Charlotte
country: United States
facility: SPARC Site 4
state: North Carolina
city: Greensboro
country: United States
facility: SPARC Site 24
state: North Carolina
city: Winston-Salem
country: United States
facility: SPARC Site 2
state: North Carolina
city: Winston-Salem
country: United States
facility: SPARC Site 75
state: North Carolina
city: Akron
country: United States
facility: SPARC Site 16
state: Ohio
city: Centerville
country: United States
facility: SPARC Site 33
state: Ohio
city: Columbus
country: United States
facility: SPARC Site 56
state: Ohio
city: Eugene
country: United States
facility: SPARC Site 12
state: Oregon
city: Springfield
country: United States
facility: SPARC Site 44
state: Oregon
city: Abington
country: United States
facility: SPARC Site 68
state: Pennsylvania
city: Indian Land
country: United States
facility: SPARC Site 29
state: South Carolina
city: Austin
country: United States
facility: SPARC Site 7
state: Texas
city: Dallas
country: United States
facility: SPARC Site 71
state: Texas
city: Houston
country: United States
facility: SPARC Site 43
state: Texas
city: Salt Lake City
country: United States
facility: SPARC Site 13
state: Utah
city: Tacoma
country: United States
facility: SPARC Site 26
state: Washington
city: Huntington
country: United States
facility: SPARC Site 74
state: West Virginia
city: Milwaukee
country: United States
facility: SPARC Site 69
state: Wisconsin
city: Waukesha
country: United States
facility: SPARC Site 67
state: Wisconsin
city: Dresden
country: Germany
facility: SPARC Site 77
city: Erbach
country: Germany
facility: SPARC Site 76
city: Teupitz
country: Germany
facility: SPARC Site 79
city: Westerstede
country: Germany
facility: SPARC Site 78
city: Budapest
country: Hungary
facility: SPARC Site 82
city: Budapest
country: Hungary
facility: SPARC site 83
city: Eger
country: Hungary
facility: SPARC Site 81
city: Esztergom
country: Hungary
facility: SPARC Site 80
city: Moscow
country: Russian Federation
facility: SPARC Site 87
city: Novosibirsk
country: Russian Federation
facility: SPARC Site 86
city: Saint Petersburg
country: Russian Federation
facility: SPARC Site 85
city: Sestroretsk
country: Russian Federation
facility: SPARC Site 84
city: Stavropol'
country: Russian Federation
facility: SPARC Site 88
city: Dnipropetrovsk
country: Ukraine
facility: SPARC Site 90
city: L'viv
country: Ukraine
facility: SPARC Site 92
city: Poltava
country: Ukraine
facility: SPARC Site 91
city: Zaporozh'ye
country: Ukraine
facility: SPARC Site 89
Study officials:
References: