Clinical trial NCT01797185: Safety Study of SPARC1104
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: 2013-02-22
Enrollment: 375
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Open-label, safety study of SPARC1104 in subjects with spasticity due to multiple sclerosis

Detailed description: Safety study of SPARC1104

Eligibility criteria: * Willingness to participate and give written informed consent
* Men and women ≥ 18 years of age
* Sexually active women who are of child bearing potential will practice an acceptable method of birth control for the duration of the trial as judged by the investigator. Examples of acceptable contraception are: condoms, foams, jellies, diaphragm, intrauterine device, oral or long-acting injected contraceptives, bilateral tubal ligation, bilateral oophorectomy, hysterectomy, or having a partner who is incapable of initiating conception. The practice of contraception must have started at least 3 months prior to trial entry.
* If female, negative pregnancy test result at Screening
* Diagnosed with MS and a known history of spasticity
* Meet one of the following criteria o Subjects who completed the double-blind randomized withdrawal phase (Part 3) of trial CLR_09_21 with no major protocol violation

Primary outcomes:
measure: Number of Subjects With Adverse Events
timeFrame: 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: SPARC site 4
state: Arizona
city: Phoenix
country: United States
facility: SPARC Site 34
state: Arizona
city: Tucson
country: United States
facility: SPARC Site 1
state: Arizona
city: Costa Mesa
country: United States
facility: SPARC Site 30
state: California
city: Newport Beach
country: United States
facility: SPARC Site 14
state: California
city: Basalt
country: United States
facility: SPARC Site 32
state: Colorado
city: Denver
country: United States
facility: SPARC Site 5
state: Colorado
city: Derby
country: United States
facility: SPARC Site 7
state: Connecticut
city: Hartford
country: United States
facility: SPARC site 47
state: Connecticut
city: New London
country: United States
facility: SPARC Site 8
state: Connecticut
city: Washington
country: United States
facility: SPARC Site 50
state: District of Columbia
city: Maitland
country: United States
facility: SPARC Site 35
state: Florida
city: Miami
country: United States
facility: SPARC Site 59
state: Florida
city: Ormond Beach
country: United States
facility: SPARC Site 6
state: Florida
city: Port Charlotte
country: United States
facility: SPARC Site 11
state: Florida
city: Sarasota
country: United States
facility: SPARC Site 13
state: Florida
city: Sunrise
country: United States
facility: SPARC Site 25
state: Florida
city: Tampa
country: United States
facility: SPARC Site 55
state: Florida
city: Tampa
country: United States
facility: SPARC Site 33
state: Florida
city: Lenexa
country: United States
facility: SPARC site 45
state: Kansas
city: Overland Park
country: United States
facility: SPARC Site 24
state: Kansas
city: Louisville
country: United States
facility: SPARC Site 44
state: Kentucky
city: Alexandria
country: United States
facility: SPARC site 36
state: Louisiana
city: Baton Rouge
country: United States
facility: SPARC Site 21
state: Louisiana
city: New Orleans
country: United States
facility: SPARC Site 61
state: Louisiana
city: Baltimore
country: United States
facility: SPARC Site 49
state: Maryland
city: Fulton
country: United States
facility: SPARC Site 22
state: Maryland
city: Foxboro
country: United States
facility: SPARC Site 29
state: Massachusetts
city: Springfield
country: United States
facility: SPARC Site 17
state: Massachusetts
city: Clinton Township
country: United States
facility: SPARC Site 26
state: Michigan
city: Detroit
country: United States
facility: SPARC Site 54
state: Michigan
city: Golden Valley
country: United States
facility: SPARC Site 19
state: Minnesota
city: Flemington
country: United States
facility: SPARC Site 28
state: New Jersey
city: Albuquerque
country: United States
facility: SPARC Site 16
state: New Mexico
city: Rochester
country: United States
facility: SPARC Site 43
state: New York
city: White Plains
country: United States
facility: SPARC Site 52
state: New York
city: Charlotte
country: United States
facility: SPARC site 39
state: North Carolina
city: Greensboro
country: United States
facility: SPARC Site 18
state: North Carolina
city: Winston-Salem
country: United States
facility: SPARC Site 2
state: North Carolina
city: Centerville
country: United States
facility: SPARC Site 27
state: Ohio
city: Eugene
country: United States
facility: SPARC site 10
state: Oregon
city: Springfield
country: United States
facility: SPARC site 38
state: Oregon
city: Abington
country: United States
facility: SPARC Site 57
state: Pennsylvania
city: Indian Land
country: United States
facility: SPARC Site 23
state: South Carolina
city: Austin
country: United States
facility: SPARC Site 5
state: Texas
city: Dallas
country: United States
facility: SPARC Site 60
state: Texas
city: Houston
country: United States
facility: SPARC Site 37
state: Texas
city: Tacoma
country: United States
facility: SPARC Site 20
state: Washington
city: Huntington
country: United States
facility: SPARC Site 62
state: West Virginia
city: Milwaukee
country: United States
facility: SPARC Site 58
state: Wisconsin
city: Waukesha
country: United States
facility: SPARC Site 56
state: Wisconsin
Study officials:
References: