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Trial record 1 of 1 for:    NCT01797185
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Safety Study 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 : Completed
First Posted : February 22, 2013
Results First Posted : March 12, 2019
Last Update Posted : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
Sun Pharma Advanced Research Company Limited

Tracking Information
First Submitted Date  ICMJE February 16, 2013
First Posted Date  ICMJE February 22, 2013
Results First Submitted Date  ICMJE November 15, 2018
Results First Posted Date  ICMJE March 12, 2019
Last Update Posted Date May 3, 2019
Actual Study Start Date  ICMJE April 9, 2013
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 18, 2019)
Number of Subjects With Adverse Events [ Time Frame: 52 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 20, 2013)
  • No. of participants with adverse events [ Time Frame: 26 weeks ]
  • No. of participants with adverse vital signs [ Time Frame: 26 weeks ]
  • Number of participants with adverse laboratory parameters [ Time Frame: 26 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study of SPARC1104
Official Title  ICMJE Not Provided
Brief Summary Open-label, safety study of SPARC1104 in subjects with spasticity due to multiple sclerosis
Detailed Description Safety study of SPARC1104
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Spasticity
Intervention  ICMJE
  • Drug: SPARC1104 modified dose regimen I
    Subjects who exited study CLR_09_21
  • Drug: SPARC1104 modified dose regimen II
    Subjects who received prior treatment regimen I
  • Drug: SPARC1104 modified dose regimen III
    Subjects who received no prior treatment regimen
Study Arms  ICMJE
  • Experimental: SPARC1104 group 1
    Intervention: Drug: SPARC1104 modified dose regimen I
  • Experimental: SPARC1104 group 2
    Intervention: Drug: SPARC1104 modified dose regimen II
  • Experimental: SPARC1104 group 3
    Intervention: Drug: SPARC1104 modified dose regimen III
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 18, 2019)
375
Original Estimated Enrollment  ICMJE
 (submitted: February 20, 2013)
100
Actual Study Completion Date  ICMJE October 2017
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01797185
Other Study ID Numbers  ICMJE CLR_11_04
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sun Pharma Advanced Research Company Limited
Study Sponsor  ICMJE Sun Pharma Advanced Research Company Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Sun Pharma Advanced Research Company Limited
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP