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Efficacy and Safety of SPARC0921 in Subjects With Spasticity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01457352
Recruitment Status : Completed
First Posted : October 21, 2011
Results First Posted : June 18, 2019
Last Update Posted : June 18, 2019
Sponsor:
Information provided by (Responsible Party):
Sun Pharma Advanced Research Company Limited

Brief Summary:
The purpose of this study is to assess whether SPARC0921 demonstrate efficacy and safety in the treatment of spasticity.

Condition or disease Intervention/treatment Phase
Spasticity Drug: SPARC0921 Drug: Placebo0921 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 392 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Actual Study Start Date : November 14, 2012
Actual Primary Completion Date : August 25, 2017
Actual Study Completion Date : August 25, 2017

Arm Intervention/treatment
Experimental: SPARC0921 Drug: SPARC0921
Placebo Comparator: Placebo0921 Drug: Placebo0921



Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01457352


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

Documents provided by Sun Pharma Advanced Research Company Limited:
Study Protocol  [PDF] February 24, 2012
Statistical Analysis Plan  [PDF] September 21, 2017

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Responsible Party: Sun Pharma Advanced Research Company Limited
ClinicalTrials.gov Identifier: NCT01457352    
Other Study ID Numbers: CLR_09_21
First Posted: October 21, 2011    Key Record Dates
Results First Posted: June 18, 2019
Last Update Posted: June 18, 2019
Last Verified: June 2019
Keywords provided by Sun Pharma Advanced Research Company Limited:
spasticity
Additional relevant MeSH terms:
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Muscle Spasticity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases