Study of SPARC1103 in Subjects With Spasticity

Phase 2

Completed

• Conditions: Spasticity
• Interventions: Drug: SPARC1103 low dose; Drug: SPARC1103 high dose; Drug: SPARC Placebo

• Registration Number: NCT02027025
• Lead Sponsor: Sun Pharma Advanced Research Company Limited

Brief Summary

Study of SPARC1103 in subjects with spasticity

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-01
• Study First Submitted QC: 2014-01-01
• Study First Posted: 2014-01-03
• Study Start: 2014-04-21
• Primary Completion: 2017-04-28
• Study Completion: 2017-04-28
• Results First Submitted: 2018-10-16
• Results First Submitted QC: 2018-12-17
• Results First Posted: 2019-01-15
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-02
• Last Update Posted: 2019-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SPARC 1103 low dose	SPARC1103 low dose	The subjects will receive SPARC 1103 low dose
SPARC1103 high dose	SPARC1103 high dose	The subjects will receive SPARC1103 high dose
SPARC Placebo	SPARC Placebo	The subjects will receive SPARC Placebo

Primary Outcome Measures

Name	Time	Method
Least Square Mean Difference (Placebo Versus Each SPARC1103 Dose) in Change From Baseline in Modified Ashworth Score	Baseline, Day 24	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).

Secondary Outcome Measures

Name	Time	Method
Least Square Mean Difference (Placebo Versus Each SPARC1103 Dose) in Change From Baseline in Night Time Awakening Score	Baseline, Day 24	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)
Least Square Mean Difference (Placebo Versus Each SPARC1103 Dose) in Change From Baseline in Spasm Frequency	Baseline, Day 24	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
Clinical Global Impression of Change Results at 24 Hours Post Dose on Day 24	Baseline, 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
Subject Global Impression of Severity of Spasticity	Baseline, Day 24	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

Trial Locations

Locations (23)

SPARC Site 21; 🇺🇦 Ivano-Frankivs'k, Ukraine

SPARC Site 23; 🇺🇦 L'viv, Ukraine

SPARC Site 4; 🇺🇸 Long Beach, California, United States

SPARC Site 7; 🇺🇸 Miami Springs, Florida, United States

SPARC Site 19; 🇷🇺 Smolensk, Russian Federation

SPARC Site 10; 🇺🇸 Aurora, Colorado, United States

SPARC Site 6; 🇺🇸 San Diego, California, United States

SPARC Site 2; 🇺🇸 Jacksonville, Florida, United States

SPARC Site 5; 🇺🇸 Orlando, Florida, United States

SPARC Site 13; 🇺🇸 Tampa, Florida, United States

SPARC Site 11; 🇺🇸 Kansas City, Kansas, United States

SPARC Site 3; 🇺🇸 Lenexa, Kansas, United States

SPARC Site 14; 🇺🇸 Albuquerque, New Mexico, United States

SPARC Site 1; 🇺🇸 Bingham Farms, Michigan, United States

SPARC Site 8; 🇺🇸 Cleveland, Ohio, United States

SPARC Site 9; 🇺🇸 Charlotte, North Carolina, United States

SPARC Site 18; 🇷🇺 Moscow, Russian Federation

SPARC Site 12; 🇺🇸 Richland, Washington, United States

SPARC Site 17; 🇷🇺 Nizhniy Novgorod, Russian Federation

SPARC Site 20; 🇷🇺 Samara, Russian Federation

SPARC Site 16; 🇷🇺 Ufa, Russian Federation

SPARC Site 15; 🇺🇸 Miami, Florida, United States

SPARC Site 22; 🇺🇦 Dnepropetrovsk, Ukraine