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Study of SPARC1103 in Subject With Spasticity

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sun Pharma Advanced Research Company Limited
ClinicalTrials.gov Identifier:
NCT02027025
First received: January 1, 2014
Last updated: May 23, 2017
Last verified: May 2017
  Purpose
Study of SPARC1103 in subjects wirth spasticity

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

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:
  • Primary efficacy outcome: Improvement in total modified Ashworth score [ Time Frame: Day 24 ]
    Mean change from Baseline in total modified Ashworth score assessed over 24 hours


Secondary Outcome Measures:
  • Spasm frequency [ Time Frame: Day 24 ]
    Subject's assessment of their overall spasm frequency

  • Nighttime awakening score [ Time Frame: Day 24 ]
  • Clinical global impression of change [ Time Frame: Day 24 ]
  • Subject's global impression of change [ Time Frame: Day 24 ]

Estimated Enrollment: 135
Actual Study Start Date: March 2014
Estimated Study Completion Date: September 1, 2017
Primary Completion Date: April 28, 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

  Eligibility

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 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 ClinicalTrials.gov identifier: NCT02027025

Locations
United States, California
SPARC Site 4
Long Beach, California, United States
SPARC Site 7
San Diego, California, United States
United States, Colorado
SPARC Site 11
Aurora, Colorado, United States
United States, Florida
SPARC Site 2
Jacksonville, Florida, United States
SPARC Site 8
Miami Springs, Florida, United States
SPARC Site 6
Orlando, Florida, United States
SPARC Site 5
Saint Petersburg, Florida, United States
SPARC Site 14
Tampa, Florida, United States
United States, Georgia
SPARC Site 15
Douglasville, Georgia, United States
United States, Kansas
SPARC Site 12
Kansas City, Kansas, United States
SPARC Site 3
Lenexa, Kansas, United States
United States, Michigan
SPARC Site 1
Bingham Farms, Michigan, United States
United States, North Carolina
SPARC Site 10
Charlotte, North Carolina, United States
United States, Ohio
SPARC Site 9
Cleveland, Ohio, United States
United States, Washington
SPARC Site 13
Richland, Washington, United States
Russian Federation
SPARC Site 18
Moscow, Russian Federation
SPARC Site 17
Nizhniy Novgorod, Russian Federation
SPARC Site 21
Nizhniy Novgorod, Russian Federation
SPARC Site 20
Samara, Russian Federation
SPARC Site 19
Smolensk, Russian Federation
SPARC Site 16
Ufa, Russian Federation
Ukraine
SPARC Site 25
Chernivtsi, Ukraine
SPARC Site 23
Dnepropetrovsk, Ukraine
SPARC Site 22
Ivano-Frankivs'k, Ukraine
SPARC Site 24
L'viv, Ukraine
Sponsors and Collaborators
Sun Pharma Advanced Research Company Limited
  More Information

Responsible Party: Sun Pharma Advanced Research Company Limited
ClinicalTrials.gov Identifier: NCT02027025     History of Changes
Other Study ID Numbers: CLR_11_03
Study First Received: January 1, 2014
Last Updated: May 23, 2017

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

ClinicalTrials.gov processed this record on August 23, 2017