Clinical trial NCT02027025: Study of SPARC1103 in Subjects With Spasticity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Spasticity
Keywords: Spasticity, Multiple sclerosis
Lead sponsor: Sun Pharma Advanced Research Company Limited
Sponsor class: INDUSTRY
First posted: 2014-01-03
Enrollment: 142
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: Study of SPARC1103 in subjects with spasticity


Eligibility criteria: Inclusion Criteria:

* Men and women greater than or equal to 18 years of age
* 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:

* Administration of an investigational drug or device within 30 days prior to Screening Visit 1
* 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

Primary outcomes:
measure: Least Square Mean Difference (Placebo Versus Each SPARC1103 Dose) in Change From Baseline in Modified Ashworth Score
timeFrame: Baseline, Day 24
Secondary outcomes:
measure: Least Square Mean Difference (Placebo Versus Each SPARC1103 Dose) in Change From Baseline in Night Time Awakening Score
timeFrame: Baseline, Day 24
measure: Least Square Mean Difference (Placebo Versus Each SPARC1103 Dose) in Change From Baseline in Spasm Frequency
timeFrame: Baseline, Day 24
measure: Clinical Global Impression of Change Results at 24 Hours Post Dose on Day 24
timeFrame: Baseline, Day 24
measure: Subject Global Impression of Severity of Spasticity
timeFrame: Baseline, Day 24
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: SPARC Site 4
state: California
city: San Diego
country: United States
facility: SPARC Site 6
state: California
city: Aurora
country: United States
facility: SPARC Site 10
state: Colorado
city: Jacksonville
country: United States
facility: SPARC Site 2
state: Florida
city: Miami Springs
country: United States
facility: SPARC Site 7
state: Florida
city: Miami
country: United States
facility: SPARC Site 15
state: Florida
city: Orlando
country: United States
facility: SPARC Site 5
state: Florida
city: Tampa
country: United States
facility: SPARC Site 13
state: Florida
city: Kansas City
country: United States
facility: SPARC Site 11
state: Kansas
city: Lenexa
country: United States
facility: SPARC Site 3
state: Kansas
city: Bingham Farms
country: United States
facility: SPARC Site 1
state: Michigan
city: Albuquerque
country: United States
facility: SPARC Site 14
state: New Mexico
city: Charlotte
country: United States
facility: SPARC Site 9
state: North Carolina
city: Cleveland
country: United States
facility: SPARC Site 8
state: Ohio
city: Richland
country: United States
facility: SPARC Site 12
state: Washington
city: Moscow
country: Russian Federation
facility: SPARC Site 18
city: Nizhniy Novgorod
country: Russian Federation
facility: SPARC Site 17
city: Samara
country: Russian Federation
facility: SPARC Site 20
city: Smolensk
country: Russian Federation
facility: SPARC Site 19
city: Ufa
country: Russian Federation
facility: SPARC Site 16
city: Dnepropetrovsk
country: Ukraine
facility: SPARC Site 22
city: Ivano-Frankivs'k
country: Ukraine
facility: SPARC Site 21
city: L'viv
country: Ukraine
facility: SPARC Site 23
Study officials:
References: