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Efficacy and Safety of SPARC0921 in Subjects With Spasticity

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01457352
First Posted: October 21, 2011
Last Update Posted: May 25, 2017
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.
Information provided by (Responsible Party):
Sun Pharma Advanced Research Company Limited
  Purpose
The purpose of this study is to assess whether SPARC0921 demonstrate efficacy and safety in the treatment of spasticity.

Condition Intervention Phase
Spasticity Drug: SPARC0921 Drug: Placebo0921 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment

Further study details as provided by Sun Pharma Advanced Research Company Limited:

Primary Outcome Measures:
  • The primary efficacy outcome is the proportion of subjects who become a treatment failure during double-blind randomized withdrawal [ Time Frame: Week 22 ]
  • Determining the safety profile when administered over >12 weeks [ Time Frame: Week 22 ]

Secondary Outcome Measures:
  • Subject Global Impression of Severity (SGIS)assessment [ Time Frame: Week 22 ]

Estimated Enrollment: 300
Study Start Date: September 2012
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SPARC0921 Drug: SPARC0921
Placebo Comparator: Placebo0921 Drug: Placebo0921

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Men and women age 18 years and older
  • Known history of spasticity due to MS prior to starting baclofen
  • 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
  Contacts and Locations
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


  Hide Study Locations
Locations
United States, Arizona
SPARC site 1
Gilbert, Arizona, United States
SPARC Site 64
Phoenix, Arizona, United States
United States, California
SPARC Site 2
Costa Mesa, California, United States
SPARC Site 3
Newport Beach, California, United States
United States, Colorado
SPARC Site 62
Basalt, Colorado, United States
SPARC Site 4
Denver, Colorado, United States
United States, Connecticut
SPARC Site 6
Derby, Connecticut, United States
SPARC Site 72
Hartford, Connecticut, United States
SPARC Site 7
New London, Connecticut, United States
United States, District of Columbia
SPARC Site 8
Washington, D.C., District of Columbia, United States
United States, Florida
SPARC Site 9
Bradenton, Florida, United States
SPARC Site 10
Jacksonville, Florida, United States
SPARC Site 65
Maitland, Florida, United States
SPARC Site 12
Miami, Florida, United States
SPARC Site 13
Ormond Beach, Florida, United States
SPARC Site 14
Port Charlotte, Florida, United States
SPARC Site 15
Sarasota, Florida, United States
SPARC Site 16
Sunrise, Florida, United States
SPARC Site 17
Tampa, Florida, United States
SPARC Site 63
Tampa, Florida, United States
United States, Kansas
SPARC Site 21
Lenexa, Kansas, United States
SPARC Site 22
Overland Park, Kansas, United States
United States, Kentucky
SPARC Site 23
Louisville, Kentucky, United States
United States, Louisiana
SPARC Site 66
Alexandria, Louisiana, United States
SPARC Site 24
Baton Rouge, Louisiana, United States
SPARC Site 25
New Orleans, Louisiana, United States
United States, Massachusetts
SPARC Site 28
Foxborough, Massachusetts, United States
SPARC Site 29
Springfield, Massachusetts, United States
United States, Michigan
SPARC Site 30
Clinton, Michigan, United States
SPARC Site 31
Detroit, Michigan, United States
United States, Minnesota
SPARC Site 32
Golden Valley, Minnesota, United States
United States, Nevada
SPARC Site 74
Hender, Nevada, United States
United States, New Jersey
SPARC Site 35
Flemington, New Jersey, United States
SPARC Site 70
Stratford, New Jersey, United States
United States, New Mexico
SPARC Site 36
Albuquerque, New Mexico, United States
United States, New York
SPARC Site 37
Rochester, New York, United States
United States, North Carolina
SPARC Site 75
Charlotte, North Carolina, United States
SPARC Site 76
Charlotte, North Carolina, United States
SPARC Site 40
Greensboro, North Carolina, United States
SPARC Site 41
Winston-Salem, North Carolina, United States
SPARC Site 69
Winston-Salem, North Carolina, United States
United States, Ohio
SPARC Site 43
Akron, Ohio, United States
SPARC Site 44
Centerville, Ohio, United States
SPRAC Site 45
Columbus, Ohio, United States
United States, Oregon
SPARC Site 73
Eugene, Oregon, United States
SPARC Site 68
Springfield, Oregon, United States
United States, Pennsylvania
SPARC Site 48
Abington, Pennsylvania, United States
United States, South Carolina
SPARC Site 52
Indian Land, South Carolina, United States
United States, Texas
SPARC Site 54
Austin, Texas, United States
SPARC Site 55
Dallas, Texas, United States
SPARC Site 67
Houston, Texas, United States
United States, Utah
SPARC Site 71
Salt Lake City, Utah, United States
United States, Washington
SPARC Site 56
Tacoma, Washington, United States
United States, West Virginia
SPARC Site 57
Huntington, West Virginia, United States
United States, Wisconsin
SPARC Site 58
Milwaukee, Wisconsin, United States
SPARC Site 59
Waukesha, Wisconsin, United States
Germany
SPARC Site 91
Dresden, Germany
SPARC Site 90
Erbach, Germany
SPARC Site 93
Teupitz, Germany
SPARC Site 92
Westerstede, Germany
Hungary
SPARC Site 88
Budapest, Hungary
SPARC site 89
Budapest, Hungary
SPARC Site 87
Eger, Hungary
SPARC Site 86
Esztergom, Hungary
Russian Federation
SPARC Site 84
Moscow, Russian Federation
SPARC Site 83
Novosibirsk, Russian Federation
SPARC Site 82
Saint Petersburg, Russian Federation
SPARC Site 81
Sestroretsk, Russian Federation
SPARC Site 85
Stavropol', Russian Federation
Ukraine
SPARC Site 78
Dnipropetrovsk, Ukraine
SPARC Site 80
L'viv, Ukraine
SPARC Site 79
Poltava, Ukraine
SPARC Site 77
Zaporozh'ye, Ukraine
Sponsors and Collaborators
Sun Pharma Advanced Research Company Limited
Investigators
Study Director: Shravanti Bhowmik, MD Sun Pharma Advanced Research Centre Ltd,India
  More Information

Responsible Party: Sun Pharma Advanced Research Company Limited
ClinicalTrials.gov Identifier: NCT01457352     History of Changes
Other Study ID Numbers: CLR_09_21
First Submitted: October 17, 2011
First Posted: October 21, 2011
Last Update Posted: May 25, 2017
Last Verified: May 2017

Keywords provided by Sun Pharma Advanced Research Company Limited:
Baclofen, spasticity

Additional relevant MeSH terms:
Muscle Spasticity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms