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Efficacy and Safety of SPARC0921 in Subjects With Spasticity

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. Identifier: NCT01457352
Recruitment Status : Active, not recruiting
First Posted : October 21, 2011
Last Update Posted : February 5, 2018
Information provided by (Responsible Party):
Sun Pharma Advanced Research Company Limited

Brief Summary:
The purpose of this study is to assess whether SPARC0921 demonstrate efficacy and safety in the treatment of spasticity.

Condition or disease Intervention/treatment Phase
Spasticity Drug: SPARC0921 Drug: Placebo0921 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : September 2012
Actual Primary Completion Date : September 22, 2017
Estimated Study Completion Date : March 2018

Arm Intervention/treatment
Experimental: SPARC0921 Drug: SPARC0921
Placebo Comparator: Placebo0921 Drug: Placebo0921

Primary Outcome Measures :
  1. The primary efficacy outcome is the proportion of subjects who become a treatment failure during double-blind randomized withdrawal [ Time Frame: Week 22 ]
  2. Determining the safety profile when administered over >12 weeks [ Time Frame: Week 22 ]

Secondary Outcome Measures :
  1. Subject Global Impression of Severity (SGIS)assessment [ Time Frame: Week 22 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT01457352

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Sponsors and Collaborators
Sun Pharma Advanced Research Company Limited
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Study Director: Shravanti Bhowmik, MD Sun Pharma Advanced Research Centre Ltd,India

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Responsible Party: Sun Pharma Advanced Research Company Limited Identifier: NCT01457352     History of Changes
Other Study ID Numbers: CLR_09_21
First Posted: October 21, 2011    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: February 2018

Keywords provided by Sun Pharma Advanced Research Company Limited:
Baclofen, spasticity

Additional relevant MeSH terms:
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Muscle Spasticity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms