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Study of SPARC1103 in Subject With Spasticity

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by Sun Pharma Advanced Research Company Limited
Information provided by (Responsible Party):
Sun Pharma Advanced Research Company Limited Identifier:
First received: January 1, 2014
Last updated: October 20, 2016
Last verified: October 2016
Study of SPARC1103 in subjects wirth spasticity

Condition Intervention Phase
Drug: SPARC1103 I
Drug: SPARC1103 II
Drug: SPARC Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics 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:
  • Primary efficacy outcome: Improvement in total modified Ashworth score [ Time Frame: Day 24 ] [ Designated as safety issue: No ]
    Mean change from Baseline in total modified Ashworth score assessed over 24 hours

Secondary Outcome Measures:
  • Spasm frequency [ Time Frame: Day 24 ] [ Designated as safety issue: No ]
    Subject's assessment of their overall spasm frequency

  • Nighttime awakening score [ Time Frame: Day 24 ] [ Designated as safety issue: No ]
  • Clinical global impression of change [ Time Frame: Day 24 ] [ Designated as safety issue: No ]
  • Subject's global impression of change [ Time Frame: Day 24 ] [ Designated as safety issue: No ]

Estimated Enrollment: 135
Study Start Date: March 2014
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: SPARC1103 I
The subjects will receive SPARC1103 I
Drug: SPARC1103 I
Active Comparator: SPARC1103 II
The subjects will receive SPARC1103 II
Drug: SPARC1103 II
Placebo Comparator: SPARC Placebo
The subjects will receive SPARC Placebo
Drug: SPARC Placebo


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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:

  • History of hypersensitivity to baclofen
  • Treated with intrathecal baclofen prior to study
  • Concomitant neurologic conditions causing spasticity
  • Any medical condition, including psychiatric disease or epilepsy, which would interfere with the interpretation of the trial results
  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 identifier: NCT02027025

Contact: Shravanti Bhowmik, MD 912266455645 ext 5626

United States, California
SPARC Site 4 Recruiting
Long Beach, California, United States
SPARC Site 7 Recruiting
San Diego, California, United States
United States, Colorado
SPARC Site 11 Recruiting
Aurora, Colorado, United States
United States, Florida
SPARC Site 2 Recruiting
Jacksonville, Florida, United States
SPARC Site 8 Recruiting
Miami Springs, Florida, United States
SPARC Site 6 Active, not recruiting
Orlando, Florida, United States
SPARC Site 5 Active, not recruiting
Saint Petersburg, Florida, United States
SPARC Site 14 Recruiting
Tampa, Florida, United States
United States, Georgia
SPARC Site 15 Recruiting
Douglasville, Georgia, United States
United States, Kansas
SPARC Site 12 Recruiting
Kansas City, Kansas, United States
SPARC Site 3 Recruiting
Lenexa, Kansas, United States
United States, Michigan
SPARC Site 1 Recruiting
Bingham Farms, Michigan, United States
United States, North Carolina
SPARC Site 10 Recruiting
Charlotte, North Carolina, United States
United States, Ohio
SPARC Site 9 Recruiting
Cleveland, Ohio, United States
United States, Washington
SPARC Site 13 Recruiting
Richland, Washington, United States
Sponsors and Collaborators
Sun Pharma Advanced Research Company Limited
  More Information

Additional Information:
Responsible Party: Sun Pharma Advanced Research Company Limited Identifier: NCT02027025     History of Changes
Other Study ID Numbers: CLR_11_03 
Study First Received: January 1, 2014
Last Updated: October 20, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Sun Pharma Advanced Research Company Limited:
Spasticity, Multiple sclerosis

Additional relevant MeSH terms:
Muscle Spasticity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms processed this record on October 27, 2016