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An Open Label and Safety Study of the Safety Of SPARC1104

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

February 16, 2013
February 22, 2013
February 5, 2018
April 4, 2013
October 16, 2017   (Final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01797185 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
An Open Label and Safety Study of the Safety Of SPARC1104
Not Provided
Open-label, safety study of SPARC1104 in subjects with spasticity due to multiple sclerosis
Safety study of SPARC1104
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Spasticity
Drug: SPARC1104
Subjects will receive SPARC1104
Experimental: SPARC1104
Intervention: Drug: SPARC1104
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
Same as current
March 2018
October 16, 2017   (Final data collection date for primary outcome measure)
  • 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)
Sexes Eligible for Study: All
18 Years to 90 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01797185
CLR_11_04
No
Not Provided
Not Provided
Sun Pharma Advanced Research Company Limited
Sun Pharma Advanced Research Company Limited
Not Provided
Not Provided
Sun Pharma Advanced Research Company Limited
February 2018

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