Efficacy and Safety of SPARC0921 in Subjects With Spasticity

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:
NCT01457352
First received: October 17, 2011
Last updated: March 8, 2016
Last verified: March 2016
  Purpose
The purpose of this study is to assess whether SPARC0921 demonstrate efficacy and safety in the treatment of spasticity.

Condition Intervention Phase
Spasticity
Drug: SPARC0921
Drug: Placebo0921
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

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

Primary Outcome Measures:
  • The primary efficacy outcome is the proportion of subjects who become a treatment failure during double-blind randomized withdrawal [ Time Frame: Week 22 ] [ Designated as safety issue: No ]
  • Determining the safety profile when administered over >12 weeks [ Time Frame: Week 22 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Subject Global Impression of Severity (SGIS)assessment [ Time Frame: Week 22 ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: September 2012
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SPARC0921 Drug: SPARC0921
Placebo Comparator: Placebo0921 Drug: Placebo0921

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women age 18 years and older
  • Known history of spasticity due to MS prior to starting baclofen
  • Able and willing to comply with the protocol, including availability for a scheduled clinic visits
  • Willingness and giving of written informed consent

Exclusion Criteria:

  • In relapse or history of unstable course over the prior 30 days prior to the Screening Visit
  • Concomitant neurologic conditions causing spasticity
  • Has received an investigational drug or device within 30 days that would interfere with the study goals prior to the Screening Visit
  • Unable to comply with study procedures in the opinion of the investigator
  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: NCT01457352

Contacts
Contact: Shravanti Bhowmik, MD +9122 66455645 ext 5626 Shravanti.Bhowmik@sparcmail.com

  Show 65 Study Locations
Sponsors and Collaborators
Sun Pharma Advanced Research Company Limited
Investigators
Study Director: Shravanti Bhowmik, MD Sun Pharma Advanced Research Centre Ltd,India
  More Information

Responsible Party: Sun Pharma Advanced Research Company Limited
ClinicalTrials.gov Identifier: NCT01457352     History of Changes
Other Study ID Numbers: CLR_09_21 
Study First Received: October 17, 2011
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 August 23, 2016