Safety Study of SPARC1104

May 2, 2019 updated by: Sun Pharma Advanced Research Company Limited
Open-label, safety study of SPARC1104 in subjects with spasticity due to multiple sclerosis

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Safety study of SPARC1104

Study Type

Interventional

Enrollment (Actual)

375

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • SPARC Site 4
      • Phoenix, Arizona, United States, 85004
        • SPARC Site 34
      • Tucson, Arizona, United States, 85704
        • SPARC Site 1
    • California
      • Costa Mesa, California, United States, 92626
        • SPARC Site 30
      • Newport Beach, California, United States, 92663
        • SPARC Site 14
    • Colorado
      • Basalt, Colorado, United States, 81621
        • SPARC Site 32
      • Denver, Colorado, United States, 80209
        • SPARC Site 5
    • Connecticut
      • Derby, Connecticut, United States, 06418
        • SPARC Site 7
      • Hartford, Connecticut, United States, 06112
        • SPARC site 47
      • New London, Connecticut, United States, 06320
        • SPARC Site 8
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • SPARC Site 50
    • Florida
      • Maitland, Florida, United States, 32751
        • SPARC Site 35
      • Miami, Florida, United States, 33136
        • SPARC Site 59
      • Ormond Beach, Florida, United States, 32174
        • SPARC Site 6
      • Port Charlotte, Florida, United States, 33952
        • SPARC Site 11
      • Sarasota, Florida, United States, 34233
        • SPARC Site 13
      • Sunrise, Florida, United States, 33351
        • SPARC Site 25
      • Tampa, Florida, United States, 33612
        • SPARC Site 55
      • Tampa, Florida, United States, 33634
        • SPARC Site 33
    • Kansas
      • Lenexa, Kansas, United States, 66214
        • SPARC site 45
      • Overland Park, Kansas, United States, 66212
        • SPARC Site 24
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • SPARC Site 44
    • Louisiana
      • Alexandria, Louisiana, United States, 73101
        • SPARC site 36
      • Baton Rouge, Louisiana, United States, 70810
        • SPARC Site 21
      • New Orleans, Louisiana, United States, 70121
        • SPARC Site 61
    • Maryland
      • Baltimore, Maryland, United States, 21287-6985
        • SPARC Site 49
      • Fulton, Maryland, United States, 20759
        • SPARC Site 22
    • Massachusetts
      • Foxboro, Massachusetts, United States, 02035
        • SPARC Site 29
      • Springfield, Massachusetts, United States, 01104
        • SPARC Site 17
    • Michigan
      • Clinton Township, Michigan, United States, 48035
        • SPARC Site 26
      • Detroit, Michigan, United States, 48202
        • SPARC Site 54
    • Minnesota
      • Golden Valley, Minnesota, United States, 55422
        • SPARC Site 19
    • New Jersey
      • Flemington, New Jersey, United States, 08822
        • SPARC Site 28
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108
        • SPARC Site 16
    • New York
      • Rochester, New York, United States, 14642
        • SPARC Site 43
      • White Plains, New York, United States, 10605
        • SPARC Site 52
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • SPARC site 39
      • Greensboro, North Carolina, United States, 27405
        • SPARC Site 18
      • Winston-Salem, North Carolina, United States, 27103
        • SPARC Site 2
    • Ohio
      • Centerville, Ohio, United States, 45459
        • SPARC Site 27
    • Oregon
      • Eugene, Oregon, United States, 97041
        • SPARC Site 10
      • Springfield, Oregon, United States, 97477
        • SPARC site 38
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19090
        • SPARC Site 57
    • South Carolina
      • Indian Land, South Carolina, United States, 29707
        • SPARC Site 23
    • Texas
      • Austin, Texas, United States, 78731
        • SPARC Site 5
      • Dallas, Texas, United States, 75246
        • SPARC Site 60
      • Houston, Texas, United States, 77025
        • SPARC Site 37
    • Washington
      • Tacoma, Washington, United States, 98405
        • SPARC Site 20
    • West Virginia
      • Huntington, West Virginia, United States, 25701
        • SPARC Site 62
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • SPARC Site 58
      • Waukesha, Wisconsin, United States, 53188
        • SPARC Site 56

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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 o Subjects who completed the double-blind randomized withdrawal phase (Part 3) of trial CLR_09_21 with no major protocol violation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SPARC1104 group 1
Drug: SPARC1104 modified dose regimen I
Subjects who exited study CLR_09_21
Experimental: SPARC1104 group 2
Drug: SPARC1104 modified dose regimen II
Subjects who received prior treatment regimen I
Experimental: SPARC1104 group 3
Drug: SPARC1104 modified dose regimen III
Subjects who received no prior treatment regimen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Subjects With Adverse Events
Time Frame: 52 weeks
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Pharma Advanced Research Company Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 9, 2013

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

February 16, 2013

First Submitted That Met QC Criteria

February 20, 2013

First Posted (Estimate)

February 22, 2013

Study Record Updates

Last Update Posted (Actual)

May 3, 2019

Last Update Submitted That Met QC Criteria

May 2, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLR_11_04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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