Study of SPARC1103 in Subjects With Spasticity

Phase 2CompletedNCT02027025

Sun Pharma Advanced Research Company Limited142 enrolled

Overview

Study of SPARC1103 in subjects with spasticity

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

142

Conditions

Spasticity

Interventions

SPARC1103 low doseDRUG

once daily

SPARC1103 high doseDRUG

once daily

SPARC PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (23)

SPARC Site 4

Long Beach, California, United States

SPARC Site 6

San Diego, California, United States

Outcomes

Primary Outcomes

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).

Time frame: Baseline, Day 24

Secondary Outcomes

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)

Time frame: 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

Time frame: 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

Time frame: Baseline, Day 24

Subject Global Impression of Severity of Spasticity

Data from ClinicalTrials.gov

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