Efficacy and Safety of SPARC0921 in Subjects With Spasticity

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by Sun Pharma Advanced Research Company Limited
Sponsor:
Information provided by (Responsible Party):
Sun Pharma Advanced Research Company Limited
ClinicalTrials.gov Identifier:
NCT01457352
First received: October 17, 2011
Last updated: March 8, 2016
Last verified: March 2016
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
  • Determining the safety profile when administered over >12 weeks [ Time Frame: Week 22 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Subject Global Impression of Severity (SGIS)assessment [ Time Frame: Week 22 ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: September 2012
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SPARC0921 Drug: SPARC0921
Placebo Comparator: Placebo0921 Drug: Placebo0921

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01457352

Contacts
Contact: Shravanti Bhowmik, MD +9122 66455645 ext 5626 Shravanti.Bhowmik@sparcmail.com

  Hide Study Locations
Locations
United States, Arizona
SPARC site 1 Recruiting
Gilbert, Arizona, United States
SPARC Site 64 Recruiting
Phoenix, Arizona, United States
SPARC Site 60 Withdrawn
Tucson, Arizona, United States
United States, California
SPARC Site 2 Not yet recruiting
Costa Mesa, California, United States
SPARC Site 3 Recruiting
Newport Beach, California, United States
United States, Colorado
SPARC Site 62 Recruiting
Basalt, Colorado, United States
SPARC Site 4 Recruiting
Denver, Colorado, United States
SPARC Site 5 Withdrawn
Fort Collins, Colorado, United States
United States, Connecticut
SPARC Site 6 Recruiting
Derby, Connecticut, United States
SPARC Site 7 Recruiting
New London, Connecticut, United States
United States, District of Columbia
SPARC Site 8 Recruiting
Washington, District of Columbia, United States
United States, Florida
SPARC Site 9 Recruiting
Bradenton, Florida, United States
SPARC Site 10 Recruiting
Jacksonville, Florida, United States
SPARC Site 65 Recruiting
Maitland, Florida, United States
Contact       neurolgyassoc@hotmail.com   
SPARC Site 11 Withdrawn
Miami, Florida, United States
SPARC Site 12 Recruiting
Miami, Florida, United States
SPARC Site 13 Recruiting
Ormond Beach, Florida, United States
SPARC Site 14 Recruiting
Port Charlotte, Florida, United States
SPARC Site 15 Recruiting
Sarasota, Florida, United States
SPARC Site 16 Recruiting
Sunrise, Florida, United States
SPARC Site 17 Recruiting
Tampa, Florida, United States
SPARC Site 63 Not yet recruiting
Tampa, Florida, United States
United States, Georgia
SPARC Site 18 Withdrawn
Atlanta, Georgia, United States
SPARC Site 19 Withdrawn
Atlanta, Georgia, United States
United States, Indiana
SPARC Site 20 Withdrawn
Indianapolis, Indiana, United States
United States, Kansas
SPARC Site 21 Recruiting
Lenexa, Kansas, United States
SPARC Site 22 Recruiting
Overland Park, Kansas, United States
United States, Kentucky
SPARC Site 23 Recruiting
Louisville, Kentucky, United States
United States, Louisiana
SPARC Site 24 Recruiting
Baton Rouge, Louisiana, United States
SPARC Site 25 Recruiting
New Orleans, Louisiana, United States
United States, Maryland
SPARC Site 26 Withdrawn
Baltimore, Maryland, United States
SPARC Site 27 Withdrawn
Fulton, Maryland, United States
United States, Massachusetts
SPARC Site 28 Recruiting
Foxboro, Massachusetts, United States
SPARC Site 29 Recruiting
Springfield, Massachusetts, United States
United States, Michigan
SPARC Site 30 Recruiting
Clinton Twp., Michigan, United States
SPARC Site 31 Recruiting
Detroit, Michigan, United States
United States, Minnesota
SPARC Site 32 Recruiting
Golden Valley, Minnesota, United States
United States, Missouri
SPARC Site 33 Withdrawn
Columbia, Missouri, United States
United States, Nebraska
SPARC Site 34 Withdrawn
Omaha, Nebraska, United States
United States, New Jersey
SPARC Site 35 Recruiting
Flemington, New Jersey, United States
United States, New Mexico
SPARC Site 36 Recruiting
Albuquerque, New Mexico, United States
United States, New York
SPARC Site 37 Recruiting
Rochester, New York, United States
SPARC Site 38 Withdrawn
White Plains, New York, United States
United States, North Carolina
SPARC Site 39 Withdrawn
Chapel Hill, North Carolina, United States
SPARC Site 40 Recruiting
Greensboro, North Carolina, United States
SPARC Site 41 Recruiting
Winston-Salem, North Carolina, United States
United States, North Dakota
SPARC Site 42 Withdrawn
Grand Forks, North Dakota, United States
United States, Ohio
SPARC Site 43 Recruiting
Akron, Ohio, United States
SPARC Site 44 Recruiting
Centerville, Ohio, United States
SPARC Site 45 Recruiting
Columbus, Ohio, United States
United States, Oklahoma
SPARC Site 46 Withdrawn
Oklahoma City, Oklahoma, United States
SPARC Site 47 Withdrawn
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
SPARC Site 48 Recruiting
Abington, Pennsylvania, United States
SPARC Site 49 Withdrawn
Hershey, Pennsylvania, United States
SPARC Site 50 Withdrawn
Philadelphia, Pennsylvania, United States
SPARC Site 51 Withdrawn
Philadelphia, Pennsylvania, United States
United States, South Carolina
SPARC Site 52 Recruiting
Indian Land, South Carolina, United States
United States, Tennessee
SPARC Site 53 Withdrawn
Cordova, Tennessee, United States
United States, Texas
SPARC Site 54 Recruiting
Austin, Texas, United States
SPARC Site 55 Recruiting
Dallas, Texas, United States
United States, Washington
SPARC Site 61 Withdrawn
Richland, Washington, United States
SPARC Site 56 Recruiting
Tacoma, Washington, United States
United States, West Virginia
SPARC Site 57 Recruiting
Huntington, West Virginia, United States
United States, Wisconsin
SPARC Site 58 Recruiting
Milwaukee, Wisconsin, United States
SPARC Site 59 Recruiting
Waukesha, Wisconsin, United States
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 
Study First Received: October 17, 2011
Last Updated: March 8, 2016
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 28, 2016