Study of SPARC1103 in Subjects With Spasticity

Study of SPARC1103 in subjects with spasticity

Study Overview

• Status: Completed
• Conditions: Spasticity
• Intervention / Treatment: Drug: SPARC1103 low dose; Drug: SPARC1103 high dose; Drug: SPARC Placebo

• Study Type: Interventional
• Enrollment (Actual): 142
• Phase: Phase 2

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation
    • SPARC Site 18
  • Nizhniy Novgorod, Russian Federation
    • SPARC Site 17
  • Samara, Russian Federation
    • SPARC Site 20
  • Smolensk, Russian Federation
    • SPARC Site 19
  • Ufa, Russian Federation
    • SPARC Site 16
• Ukraine
  • Dnepropetrovsk, Ukraine
    • SPARC Site 22
  • Ivano-Frankivs'k, Ukraine
    • SPARC Site 21
  • L'viv, Ukraine
    • SPARC Site 23
• United States
  • California
    • Long Beach, California, United States
      • SPARC Site 4
    • San Diego, California, United States
      • SPARC Site 6
  • Colorado
    • Aurora, Colorado, United States
      • SPARC Site 10
  • Florida
    • Jacksonville, Florida, United States
      • SPARC Site 2
    • Miami, Florida, United States
      • SPARC Site 15
    • Miami Springs, Florida, United States
      • SPARC Site 7
    • Orlando, Florida, United States
      • SPARC Site 5
    • Tampa, Florida, United States
      • SPARC Site 13
  • Kansas
    • Kansas City, Kansas, United States
      • SPARC Site 11
    • Lenexa, Kansas, United States
      • SPARC Site 3
  • Michigan
    • Bingham Farms, Michigan, United States
      • SPARC Site 1
  • New Mexico
    • Albuquerque, New Mexico, United States
      • SPARC Site 14
  • North Carolina
    • Charlotte, North Carolina, United States
      • SPARC Site 9
  • Ohio
    • Cleveland, Ohio, United States
      • SPARC Site 8
  • Washington
    • Richland, Washington, United States
      • SPARC Site 12

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SPARC 1103 low dose; The subjects will receive SPARC 1103 low dose	Drug: SPARC1103 low dose; once daily
Active Comparator: SPARC1103 high dose; The subjects will receive SPARC1103 high dose	Drug: SPARC1103 high dose; once daily
Placebo Comparator: SPARC Placebo; The subjects will receive SPARC Placebo	Drug: SPARC Placebo

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sun Pharma Advanced Research Company Limited

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2014
• Primary Completion (Actual): April 28, 2017
• Study Completion (Actual): April 28, 2017

Study Registration Dates

• First Submitted: January 1, 2014
• First Submitted That Met QC Criteria: January 1, 2014
• First Posted (Estimate): January 3, 2014

Study Record Updates

• Last Update Posted (Actual): May 3, 2019
• Last Update Submitted That Met QC Criteria: May 2, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Spasticity, Multiple sclerosis
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Muscle Spasticity
• Other Study ID Numbers: CLR_11_03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED