Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT01797185
Previous Study | Return to List | Next Study

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

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 modified dose regimen I Drug: SPARC1104 modified dose regimen II Drug: SPARC1104 modified dose regimen III Phase 3

Detailed Description:
Safety study of SPARC1104

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 375 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Actual Study Start Date : April 9, 2013
Actual Primary Completion Date : July 2017
Actual Study Completion Date : October 2017

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




Primary Outcome Measures :
  1. Number of Subjects With Adverse Events [ Time Frame: 52 weeks ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • 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

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


Locations
Show Show 51 study locations
Sponsors and Collaborators
Sun Pharma Advanced Research Company Limited
  Study Documents (Full-Text)

Documents provided by Sun Pharma Advanced Research Company Limited:
Study Protocol  [PDF] December 17, 2015
Statistical Analysis Plan  [PDF] October 30, 2017

Layout table for additonal information
Responsible Party: Sun Pharma Advanced Research Company Limited
ClinicalTrials.gov Identifier: NCT01797185    
Other Study ID Numbers: CLR_11_04
First Posted: February 22, 2013    Key Record Dates
Results First Posted: March 12, 2019
Last Update Posted: May 3, 2019
Last Verified: May 2019
Keywords provided by Sun Pharma Advanced Research Company Limited:
spasticity
Additional relevant MeSH terms:
Layout table for MeSH terms
Muscle Spasticity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms