Efficacy and Safety of SPARC0921 in Subjects With Spasticity

June 16, 2019 updated by: Sun Pharma Advanced Research Company Limited
The purpose of this study is to assess whether SPARC0921 demonstrate efficacy and safety in the treatment of spasticity.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

392

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Dresden, Germany
        • SPARC Site 77
      • Erbach, Germany
        • SPARC Site 76
      • Teupitz, Germany
        • SPARC Site 79
      • Westerstede, Germany
        • SPARC Site 78
  • Hungary
      • Budapest, Hungary
        • SPARC Site 82
      • Budapest, Hungary
        • SPARC site 83
      • Eger, Hungary
        • SPARC Site 81
      • Esztergom, Hungary
        • SPARC Site 80
  • Russian Federation
      • Moscow, Russian Federation
        • SPARC Site 87
      • Novosibirsk, Russian Federation
        • SPARC Site 86
      • Saint Petersburg, Russian Federation
        • SPARC Site 85
      • Sestroretsk, Russian Federation
        • SPARC Site 84
      • Stavropol', Russian Federation
        • SPARC Site 88
  • Ukraine
      • Dnipropetrovsk, Ukraine
        • SPARC Site 90
      • L'viv, Ukraine
        • SPARC Site 92
      • Poltava, Ukraine
        • SPARC Site 91
      • Zaporozh'ye, Ukraine
        • SPARC Site 89
  • United States
    • Arizona
      • Gilbert, Arizona, United States
        • SPARC Site 6
      • Phoenix, Arizona, United States
        • SPARC Site 40
    • California
      • Costa Mesa, California, United States
        • SPARC site 36
      • Newport Beach, California, United States
        • SPARC Site 20
    • Colorado
      • Basalt, Colorado, United States
        • SPARC site 38
      • Denver, Colorado, United States
        • SPARC Site 21
    • Connecticut
      • Derby, Connecticut, United States
        • SPARC Site 9
      • Hartford, Connecticut, United States
        • SPARC Site 57
      • New London, Connecticut, United States
        • SPARC Site 10
    • District of Columbia
      • Washington, District of Columbia, United States
        • SPARC Site 60
    • Florida
      • Bradenton, Florida, United States
        • SPARC Site 15
      • Jacksonville, Florida, United States
        • SPARC Site 54
      • Maitland, Florida, United States
        • SPARC Site 41
      • Miami, Florida, United States
        • SPARC Site 70
      • Ormond Beach, Florida, United States
        • SPARC Site 8
      • Port Charlotte, Florida, United States
        • SPARC Site 17
      • Sarasota, Florida, United States
        • SPARC Site 19
      • Sunrise, Florida, United States
        • SPARC Site 31
      • Tampa, Florida, United States
        • SPARC site 39
      • Tampa, Florida, United States
        • SPARC Site 65
    • Kansas
      • Lenexa, Kansas, United States
        • SPARC Site 51
      • Overland Park, Kansas, United States
        • SPARC Site 30
    • Kentucky
      • Louisville, Kentucky, United States
        • SPARC Site 50
    • Louisiana
      • Alexandria, Louisiana, United States
        • SPARC Site 42
      • Baton Rouge, Louisiana, United States
        • SPARC Site 27
      • New Orleans, Louisiana, United States
        • SPARC Site 73
    • Massachusetts
      • Foxboro, Massachusetts, United States
        • SPARC Site 35
      • Springfield, Massachusetts, United States
        • SPARC Site 23
    • Michigan
      • Clinton Township, Michigan, United States
        • SPARC Site 32
      • Detroit, Michigan, United States
        • SPARC Site 64
    • Minnesota
      • Golden Valley, Minnesota, United States
        • SPARC Site 25
    • Nevada
      • Henderson, Nevada, United States
        • SPARC Site 5
    • New Jersey
      • Flemington, New Jersey, United States
        • SPARC Site 34
      • Stratford, New Jersey, United States
        • SPARC Site 55
    • New Mexico
      • Albuquerque, New Mexico, United States
        • SPARC Site 22
    • New York
      • Rochester, New York, United States
        • SPARC Site 49
    • North Carolina
      • Charlotte, North Carolina, United States
        • SPARC site 45
      • Charlotte, North Carolina, United States
        • SPARC Site 4
      • Greensboro, North Carolina, United States
        • SPARC Site 24
      • Winston-Salem, North Carolina, United States
        • SPARC Site 2
      • Winston-Salem, North Carolina, United States
        • SPARC Site 75
    • Ohio
      • Akron, Ohio, United States
        • SPARC Site 16
      • Centerville, Ohio, United States
        • SPARC Site 33
      • Columbus, Ohio, United States
        • SPARC Site 56
    • Oregon
      • Eugene, Oregon, United States
        • SPARC Site 12
      • Springfield, Oregon, United States
        • SPARC Site 44
    • Pennsylvania
      • Abington, Pennsylvania, United States
        • SPARC Site 68
    • South Carolina
      • Indian Land, South Carolina, United States
        • SPARC Site 29
    • Texas
      • Austin, Texas, United States
        • SPARC Site 7
      • Dallas, Texas, United States
        • SPARC Site 71
      • Houston, Texas, United States
        • SPARC Site 43
    • Utah
      • Salt Lake City, Utah, United States
        • SPARC Site 13
    • Washington
      • Tacoma, Washington, United States
        • SPARC Site 26
    • West Virginia
      • Huntington, West Virginia, United States
        • SPARC Site 74
    • Wisconsin
      • Milwaukee, Wisconsin, United States
        • SPARC Site 69
      • Waukesha, Wisconsin, United States
        • SPARC Site 67

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 age 18 years and older
  • Able and willing to comply with the protocol, including availability for a scheduled clinic visits
  • Willingness and giving of written informed consent

Exclusion Criteria:

  • In relapse or history of unstable course over the prior 30 days prior to the Screening Visit
  • Concomitant neurologic conditions causing spasticity
  • Has received an investigational drug or device within 30 days that would interfere with the study goals prior to the Screening Visit
  • Unable to comply with study procedures in the opinion of the investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SPARC0921
Drug: SPARC0921
Placebo Comparator: Placebo0921
Drug: Placebo0921

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Failure Rate
Time Frame: Week 22

Percentage of subjects who had treatment failure Clinical Global Impression of Change of ≥ 5 and at least one movement with ≥ 1 unit increase in modified Ashworth score from baseline.

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 inflexion or extension.

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
Week 22

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of Spasticity Assessed by Subject Global Impression Severity Scale
Time Frame: Week 22
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
Week 22

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Pharma Advanced Research Company Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2012

Primary Completion (Actual)

August 25, 2017

Study Completion (Actual)

August 25, 2017

Study Registration Dates

First Submitted

October 17, 2011

First Submitted That Met QC Criteria

October 20, 2011

First Posted (Estimate)

October 21, 2011

Study Record Updates

Last Update Posted (Actual)

June 18, 2019

Last Update Submitted That Met QC Criteria

June 16, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLR_09_21

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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