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An Open Label and Safety Study of the Safety Of SPARC1104

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by Sun Pharma Advanced Research Company Limited
Sponsor:
Information provided by (Responsible Party):
Sun Pharma Advanced Research Company Limited
ClinicalTrials.gov Identifier:
NCT01797185
First received: February 16, 2013
Last updated: March 8, 2016
Last verified: March 2016
  Purpose
Open-label, safety study of SPARC1104 in subjects with spasticity due to multiple sclerosis

Condition Intervention Phase
Spasticity
Drug: SPARC1104
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label

Further study details as provided by Sun Pharma Advanced Research Company Limited:

Primary Outcome Measures:
  • No. of participants with adverse events [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]
  • No. of participants with adverse vital signs [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]
  • Number of participants with adverse laboratory parameters [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: April 2013
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SPARC1104 Drug: SPARC1104
Subjects will receive SPARC1104

Detailed Description:
Safety study of SPARC1104
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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

    • 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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01797185

Contacts
Contact: Shravanti Bhowmik, MD +91 22 66455645 ext 5626 shravanti.bhowmik@sparcmail.com

  Show 61 Study Locations
Sponsors and Collaborators
Sun Pharma Advanced Research Company Limited
  More Information

Responsible Party: Sun Pharma Advanced Research Company Limited
ClinicalTrials.gov Identifier: NCT01797185     History of Changes
Other Study ID Numbers: CLR_11_04 
Study First Received: February 16, 2013
Last Updated: March 8, 2016
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 28, 2016