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An Open Label and Safety Study of the Safety Of SPARC1104

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: NCT01797185
Recruitment Status : Active, not recruiting
First Posted : February 22, 2013
Last Update Posted : February 5, 2018
Information provided by (Responsible Party):
Sun Pharma Advanced Research Company Limited

Brief Summary:
Open-label, safety study of SPARC1104 in subjects with spasticity due to multiple sclerosis

Condition or disease Intervention/treatment Phase
Spasticity Drug: SPARC1104 Phase 3

Detailed Description:
Safety study of SPARC1104

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Actual Study Start Date : April 4, 2013
Primary Completion Date : October 16, 2017
Estimated Study Completion Date : March 2018

Arm Intervention/treatment
Experimental: SPARC1104 Drug: SPARC1104
Subjects will receive SPARC1104

Primary Outcome Measures :
  1. No. of participants with adverse events [ Time Frame: 26 weeks ]
  2. No. of participants with adverse vital signs [ Time Frame: 26 weeks ]
  3. Number of participants with adverse laboratory parameters [ Time Frame: 26 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • Willingness to participate and give written informed consent
  • Men and women ≥ 18 years of age
  • Sexually active women who are of child bearing potential will practice an acceptable method of birth control for the duration of the trial as judged by the investigator. Examples of acceptable contraception are: condoms, foams, jellies, diaphragm, intrauterine device, oral or long-acting injected contraceptives, bilateral tubal ligation, bilateral oophorectomy, hysterectomy, or having a partner who is incapable of initiating conception. The practice of contraception must have started at least 3 months prior to trial entry.
  • If female, negative pregnancy test result at Screening
  • Diagnosed with MS and a known history of spasticity
  • Meet one of the following criteria

    • Subjects who completed the double-blind randomized withdrawal phase (Part 3) of trial CLR_09_21 with no major protocol violation
    • Subjects who are newly diagnosed with spasticity due to MS with no history of treatment using any anti-spasticity medications, or, with a history of spasticity due to MS but with no previous exposure to baclofen treatment
    • Subjects who are receiving a stable baclofen IR dose (ie, a dose of 10 mg to 80 mg daily, having started at least 30 days prior to enrollment)

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): NCT01797185

  Hide Study Locations
United States, Arizona
SPARC Site 1
Gilbert, Arizona, United States, 85234
SPARC Site 65
Phoenix, Arizona, United States, 85004
SPARC Site 2
Tucson, Arizona, United States, 85741
United States, California
SPARC Site 61
Costa Mesa, California, United States, 92626
SPARC Site 3
Newport Beach, California, United States, 92663
United States, Colorado
SPARC Site 60
Basalt, Colorado, United States, 81621
SPARC Site 4
Denver, Colorado, United States, 80209
United States, Connecticut
SPARC Site 6
Derby, Connecticut, United States, 06418
SPARC Site 7
New London, Connecticut, United States, 06320
United States, District of Columbia
SPARC Site 8
Washington, District of Columbia, United States, 20007
United States, Florida
SPARC Site 9
Bradenton, Florida, United States, 34205
SPARC Site 10
Jacksonville, Florida, United States, 32209
SPARC Site 64
Maitland, Florida, United States, 32751
SPARC Site 12
Miami, Florida, United States, 33136
SPARC Site 13
Ormond Beach, Florida, United States, 32174
SPARC Site 15
Port Charlotte, Florida, United States, 33952
SPARC Site 16
Sarasota, Florida, United States, 34233
SPARC Site 14
Sunrise, Florida, United States, 33351
SPARC Site 17
Tampa, Florida, United States, 33612
SPARC Site 66
Tampa, Florida, United States, 33634
United States, Kansas
SPARC site 21
Lenexa, Kansas, United States, 66214
SPARC Site 22
Overland Park, Kansas, United States, 66212
United States, Kentucky
SPARC Site 23
Louisville, Kentucky, United States, 40207
United States, Louisiana
SPARC Site 62
Alexandria, Louisiana, United States, 71301
SPARC Site 24
Baton Rouge, Louisiana, United States, 70810
SPARC Site 25
New Orleans, Louisiana, United States, 70121
United States, Maryland
SPARC Site 26
Baltimore, Maryland, United States, 21287-6985
SPARC Site 27
Fulton, Maryland, United States, 20759
United States, Massachusetts
SPARC Site 28
Foxboro, Massachusetts, United States, 02035
SPARC Site 29
Springfield, Massachusetts, United States, 01104
United States, Michigan
SPARC Site 30
Clinton Township, Michigan, United States, 48035
SPARC Site 31
Detroit, Michigan, United States, 48202
United States, Minnesota
SPARC Site 32
Golden Valley, Minnesota, United States, 55422
United States, New Jersey
SPARC Site 35
Flemington, New Jersey, United States, 08822
United States, New Mexico
SPARC Site 36
Albuquerque, New Mexico, United States, 87108
United States, New York
SPARC Site 37
Rochester, New York, United States, 14642
SPARC Site 38
White Plains, New York, United States, 10605
United States, North Carolina
SPARC Site 40
Greensboro, North Carolina, United States, 27405
SPARC Site 41
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
SPARC Site 43
Akron, Ohio, United States, 44320
SPARC Site 44
Centerville, Ohio, United States, 45459
SPARC Site 45
Columbus, Ohio, United States, 43221
United States, Pennsylvania
SPARC Site 48
Abington, Pennsylvania, United States, 19090
United States, South Carolina
SPARC Site 52
Indian Land, South Carolina, United States, 29707
United States, Texas
SPARC Site 54
Austin, Texas, United States, 78731
SPARC Site 55
Dallas, Texas, United States, 75246
SPARC Site 63
Houston, Texas, United States, 77025
United States, Washington
SPARC Site 56
Tacoma, Washington, United States, 98405
United States, West Virginia
SPARC Site 57
Huntington, West Virginia, United States, 25701
United States, Wisconsin
SPARC Site 58
Milwaukee, Wisconsin, United States, 53215
SPARC Site 59
Waukesha, Wisconsin, United States, 53188
Sponsors and Collaborators
Sun Pharma Advanced Research Company Limited

Responsible Party: Sun Pharma Advanced Research Company Limited
ClinicalTrials.gov Identifier: NCT01797185     History of Changes
Other Study ID Numbers: CLR_11_04
First Posted: February 22, 2013    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: February 2018

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