Efficacy and Safety of SPARC0921 in Subjects With Spasticity

Phase 3

Completed

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

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Placebo0921	Placebo0921	-
SPARC0921	SPARC0921	-

Primary Outcome Measures

Name	Time	Method
Treatment Failure Rate	Week 22	Percentage of subjects who had treatment failure Clinical Global Impression of Change of ≥ 5 and at least one movement with ≥ 1 unit increase in modified Ashworth score from baseline. The modified Ashworth scale is a 6-point scale as follows: Minimum score of 0 (better outcome) = no increase in tone Maximum score of 4 (worst outcome) = affected part(s) rigid inflexion or extension. The clinician (other than the one performing the Modified Ashworth Scale assessment) rated his/her overall (global) impression of change in spasticity using the 7-point scale shown below: Minimum score of 1 (better outcome) = very much improved Maximum score of 7 (very much worse) = very much worse

Secondary Outcome Measures

Name	Time	Method
Severity of Spasticity Assessed by Subject Global Impression Severity Scale	Week 22	The subject was asked "Overall, how would you rate the severity of your spasticity over the past 24 hours?" The 7-point scale for Subject's global impression of severity assessment is as follows: minimum score of 1 = normal, no spasticity maximum score of 7 (worst outcome)= worst spasticity imaginable

Locations (73): SPARC site 6
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Gilbert, Arizona, United States
SPARC Site 40
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Phoenix, Arizona, United States
SPARC Site 36
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Costa Mesa, California, United States
SPARC Site 20
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Newport Beach, California, United States
SPARC Site 38
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Basalt, Colorado, United States
SPARC Site 21
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Denver, Colorado, United States
SPARC Site 9
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Derby, Connecticut, United States
SPARC Site 57
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Hartford, Connecticut, United States
SPARC Site 10
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New London, Connecticut, United States
SPARC Site 60
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Washington, District of Columbia, United States
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SPARC site 6
🇺🇸Gilbert, Arizona, United States