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Study of SPARC1103 in Subjects With Spasticity

Primary Purpose

Spasticity

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SPARC1103 low dose
SPARC1103 high dose
SPARC Placebo
Sponsored by
Sun Pharma Advanced Research Company Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spasticity focused on measuring Spasticity, Multiple sclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • SPARC Site 4
  • SPARC Site 6
  • SPARC Site 10
  • SPARC Site 2
  • SPARC Site 7
  • SPARC Site 15
  • SPARC Site 5
  • SPARC Site 13
  • SPARC Site 11
  • SPARC Site 3
  • SPARC Site 1
  • SPARC Site 14
  • SPARC Site 9
  • SPARC Site 8
  • SPARC Site 12
  • SPARC Site 18
  • SPARC Site 17
  • SPARC Site 20
  • SPARC Site 19
  • SPARC Site 16
  • SPARC Site 22
  • SPARC Site 21
  • SPARC Site 23

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

SPARC 1103 low dose

SPARC1103 high dose

SPARC Placebo

Arm Description

The subjects will receive SPARC 1103 low dose

The subjects will receive SPARC1103 high dose

The subjects will receive SPARC Placebo

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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)
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
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
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

Full Information

First Posted
January 1, 2014
Last Updated
May 2, 2019
Sponsor
Sun Pharma Advanced Research Company Limited
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1. Study Identification

Unique Protocol Identification Number
NCT02027025
Brief Title
Study of SPARC1103 in Subjects With Spasticity
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
April 21, 2014 (Actual)
Primary Completion Date
April 28, 2017 (Actual)
Study Completion Date
April 28, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sun Pharma Advanced Research Company Limited

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Study of SPARC1103 in subjects with spasticity

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spasticity
Keywords
Spasticity, Multiple sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
142 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SPARC 1103 low dose
Arm Type
Active Comparator
Arm Description
The subjects will receive SPARC 1103 low dose
Arm Title
SPARC1103 high dose
Arm Type
Active Comparator
Arm Description
The subjects will receive SPARC1103 high dose
Arm Title
SPARC Placebo
Arm Type
Placebo Comparator
Arm Description
The subjects will receive SPARC Placebo
Intervention Type
Drug
Intervention Name(s)
SPARC1103 low dose
Intervention Description
once daily
Intervention Type
Drug
Intervention Name(s)
SPARC1103 high dose
Intervention Description
once daily
Intervention Type
Drug
Intervention Name(s)
SPARC Placebo
Primary Outcome Measure Information:
Title
Least Square Mean Difference (Placebo Versus Each SPARC1103 Dose) in Change From Baseline in Modified Ashworth Score
Description
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 Outcome Measure Information:
Title
Least Square Mean Difference (Placebo Versus Each SPARC1103 Dose) in Change From Baseline in Night Time Awakening Score
Description
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
Title
Least Square Mean Difference (Placebo Versus Each SPARC1103 Dose) in Change From Baseline in Spasm Frequency
Description
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
Title
Clinical Global Impression of Change Results at 24 Hours Post Dose on Day 24
Description
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
Title
Subject Global Impression of Severity of Spasticity
Description
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
Time Frame
Baseline, Day 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
SPARC Site 4
City
Long Beach
State/Province
California
Country
United States
Facility Name
SPARC Site 6
City
San Diego
State/Province
California
Country
United States
Facility Name
SPARC Site 10
City
Aurora
State/Province
Colorado
Country
United States
Facility Name
SPARC Site 2
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
SPARC Site 7
City
Miami Springs
State/Province
Florida
Country
United States
Facility Name
SPARC Site 15
City
Miami
State/Province
Florida
Country
United States
Facility Name
SPARC Site 5
City
Orlando
State/Province
Florida
Country
United States
Facility Name
SPARC Site 13
City
Tampa
State/Province
Florida
Country
United States
Facility Name
SPARC Site 11
City
Kansas City
State/Province
Kansas
Country
United States
Facility Name
SPARC Site 3
City
Lenexa
State/Province
Kansas
Country
United States
Facility Name
SPARC Site 1
City
Bingham Farms
State/Province
Michigan
Country
United States
Facility Name
SPARC Site 14
City
Albuquerque
State/Province
New Mexico
Country
United States
Facility Name
SPARC Site 9
City
Charlotte
State/Province
North Carolina
Country
United States
Facility Name
SPARC Site 8
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
SPARC Site 12
City
Richland
State/Province
Washington
Country
United States
Facility Name
SPARC Site 18
City
Moscow
Country
Russian Federation
Facility Name
SPARC Site 17
City
Nizhniy Novgorod
Country
Russian Federation
Facility Name
SPARC Site 20
City
Samara
Country
Russian Federation
Facility Name
SPARC Site 19
City
Smolensk
Country
Russian Federation
Facility Name
SPARC Site 16
City
Ufa
Country
Russian Federation
Facility Name
SPARC Site 22
City
Dnepropetrovsk
Country
Ukraine
Facility Name
SPARC Site 21
City
Ivano-Frankivs'k
Country
Ukraine
Facility Name
SPARC Site 23
City
L'viv
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Study of SPARC1103 in Subjects With Spasticity

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