Study of SPARC1103 in Subjects With Spasticity

Study Overview
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Brief Summary
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Study of SPARC1103 in subjects with spasticity

Conditions
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Spasticity

Intervention / Treatment
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* Drug: SPARC1103 low dose
* Drug: SPARC1103 high dose
* Drug: SPARC Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SPARC 1103 low dose<br>The subjects will receive SPARC 1103 low dose | Drug: SPARC1103 low dose<br>* once daily<br>|
| Active Comparator: SPARC1103 high dose<br>The subjects will receive SPARC1103 high dose | Drug: SPARC1103 high dose<br>* once daily<br>|
| Placebo Comparator: SPARC Placebo<br>The subjects will receive SPARC Placebo | Drug: SPARC Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Least Square Mean Difference (Placebo Versus Each SPARC1103 Dose) in Change From Baseline in Modified Ashworth Score | 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 in flexion or extension For calculation of modified Ashworth Score, the following scores were assigned to each category of modified Ashworth scale: not testable=NA, 0=0 units, 1=1 unit, 1+ = 2 units, 2 = 3 units, and 4 = 5 units. The total score was the sum of the scores of the 6 lower extremity muscle groups on both left and right sides (range = o0 to 60). | Baseline, Day 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Least Square Mean Difference (Placebo Versus Each SPARC1103 Dose) in Change From Baseline in Night Time Awakening Score | Nighttime awakening score was assessed as follows: The subject was asked the following question on the morning of Day 24: How many times did you wake up last night due to spasticity? Score range from 0 (better score) to infinity (worse score) | Baseline, Day 24 | 
| Least Square Mean Difference (Placebo Versus Each SPARC1103 Dose) in Change From Baseline in Spasm Frequency | Spasm frequency was assessed using following 4-point scale as follows: Minimum score of 0 (better outcome))=no spasm Maximum score of 4 (worst outcome)=Spasms occurring more than 10 times per hour | Baseline, Day 24 | 
| Clinical Global Impression of Change Results at 24 Hours Post Dose on Day 24 | 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 | Baseline, Day 24 | 
| Subject Global Impression of Severity of Spasticity | 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 | Baseline, Day 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spasticity, Multiple sclerosis