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Efficacy and Safety of Baclofen ER Capsules (GRS) in Subjects With Spasticity Due to Multiple Sclerosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Sun Pharma Advanced Research Company Limited
Information provided by (Responsible Party):
Sun Pharma Advanced Research Company Limited Identifier:
First received: October 17, 2011
Last updated: April 23, 2013
Last verified: April 2013

The purpose of this study is to assess whether baclofen ER capsules demonstrate efficacy and safety in the treatment of spasticity.

Condition Intervention Phase
Drug: Baclofen ER Capsules
Drug: Placebo GRS
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
Official Title: A Placebo-controlled Randomized Withdrawal Evaluation of the Efficacy and Safety of Baclofen ER Capsules (GRS) in Subjects With Spasticity Due to Multiple Sclerosis

Resource links provided by NLM:

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: June 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Baclofen ER Capsules
Subjects will receive open-label Baclofen ER Capsules (GRS), as a single capsule (unless otherwise noted) for up to 16 weeks in an open-label fashion and Baclofen ER Capsules (GRS) or placebo in a double-blind fashion for up to an additional 4 weeks, consistent with the down-titration schedule.
Drug: Baclofen ER Capsules
Subjects will receive open-label Baclofen ER Capsules (GRS), as a single capsule (unless otherwise noted) for up to 16 weeks in an open-label fashion and Baclofen ER Capsules (GRS) or placebo in a double-blind fashion for up to an additional 4 weeks, consistent with the down-titration schedule
Other Name: Baclofen ER
Placebo Comparator: Placebo GRS
All subjects randomized to the placebo arm will receive Placebo GRS.
Drug: Placebo GRS
All subjects randomized to the placebo arm will receive Placebo GRS.
Other Name: Placebo


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Men and women age 18 years and older
  • Women of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s) [such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), oral or long acting injected contraceptives, bilateral tubal ligation or vasectomized partner] for at least 3 months prior to study entry OR postmenopausal for at least 1 year OR surgically sterile (bilateral oophorectomy or hysterectomy)
  • If female, negative pregnancy test
  • Known history of spasticity due to MS prior to starting baclofen
  • A stable daily dose of Baclofen IR, ranging from 30 to 60 mg/day (i.e., same dose given in the same schedule for last 30 days)
  • Able and willing to comply with the protocol, including availability for a scheduled clinic visits
  • Willingness and giving of written informed consent

Exclusion Criteria:

  • History of hypersensitivity to baclofen
  • 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
  • Has had major surgery within 3 months prior to Screening visit that may affect spasticity assessments such as abdominal surgery, back surgery, or lower leg or knee surgeries
  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 identifier: NCT01457352

Contact: Shravanti Bhowmik, MD +9122 66455645 ext 626

  Hide Study Locations
United States, Arizona
Neurological Physicians of Arizona/Clinical Research Advantage Recruiting
Gilbert, Arizona, United States, 85234
Contact: Kelly Crotte, CCRC    480-610-0177   
Contact: William Grainger    480-305-5716   
NSS Clinical Research, LLC Recruiting
Tucson, Arizona, United States, 85741
Contact: Brian Peterson, CCRC    520-742-1833 ext 104   
Contact: David Weidman, MD    520-742-1833   
United States, Connecticut
Multiple Sclerosis Treatment Center Recruiting
Derby, Connecticut, United States, 6418
Contact: Cheryl Michaud    203-732-1290   
Contact: Joseph Guarnaccia, MD    203-732-1290   
Coastal Connecticute Research, LLC Recruiting
New London, Connecticut, United States, 06320
Contact: Jessie Jellison, LPN    860-437-7092   
Contact: Laurence Radin, MD    860-437-7092   
United States, District of Columbia
Georgetown University Hospital Recruiting
Washington, District of Columbia, United States, 20007
Contact: Jessica Kim    202-444-4289   
Contact: Carlo Tornatore, MD    202-444-2658   
United States, Florida
Bradenton Research Center, Inc. Recruiting
Bradenton, Florida, United States, 34205
Contact: Amy Hamilton, LPN    941-708-0005 ext 13   
Contact: William McElveen, MD    941-708-0005   
Advanced Medical Pain Management & Research Clinic Recruiting
Miami, Florida, United States, 33145
Contact: Amy Drouillard    305-646-6955   
Contact: Abel Murillo, MD    954-536-9536   
Neurology Associates of Ormond Beach Recruiting
Ormond Beach, Florida, United States, 32174
Contact: Sandra Geyer, CCRC    386-673-2500 ext 248   
Contact: James Scott, MD    386-673-2500 ext 248   
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Kanoa Folami    404-778-3772   
Contact: Niel Lava    404-778-3444   
Shepherd Center Recruiting
Atlanta, Georgia, United States, 30309
Contact: Ismari Clesson, RN    404-350-7651   
Contact: Ben Thrower, MD    404-352-2020   
United States, Kansas
Rowe Neurology Institute Recruiting
Lenexa, Kansas, United States, 66214
Contact: Leigh Kreshel, MS    913-894-1500   
Contact: Vernon Rowe, III, MD    913-894-1500   
United States, Kentucky
Norton Neurology MS Services Recruiting
Louisville, Kentucky, United States, 40207
Contact: Diana Godwin, RN    502-899-6782   
Contact: Robert Tillet Jr., MD    502-899-6782   
United States, Maryland
Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21287-6985
Contact: Sandra Cassard, ScD    913-894-1500   
Contact: John Ratchford, MD    410-614-5835   
United States, Missouri
University of Missouri Department of Physical Medicine and Rehabilitation Recruiting
Columbia, Missouri, United States, 65212
Contact: Anne Bonnett, RN    573-884-6119   
Contact: Michael Acuff, MD    573-882-3101   
United States, New York
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Eileen Scheid, RN    585-275-6673   
Contact: Andrew Goodman, MD    585-275-7854   
Burke Rehabilitation Hospital Recruiting
White Plains, New York, United States, 10605
Contact: Rosanna Cirio, MA    914-597-2476   
Contact: Argyrios Stampas, MD    914-597-2837   
United States, North Carolina
University of North Carolina at Chapel Hill Department of Neurology Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Manisha Chopra    919-843-7857   
Contact: Silvia Markovic-Plese    919-966-7857   
PMG Research of Winston-Salem Recruiting
Winston-Salem, North Carolina, United States, 27103
Contact: Beth Friedman, CCRC    336-794-8165   
Contact: Isaac Mitchell, MD    336-794-8165   
United States, North Dakota
Altru Health System/Altru Clinic-Main Recruiting
Grand Forks, North Dakota, United States, 58201
Contact: Renee Hendrickson, RN    701-780-1694   
Contact: Matthew Roller, MD    701-780-6000   
United States, Ohio
The Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43212
Contact: Erin Marshall    614-366-3752   
Contact: Aaron Boster, MD    614-366-3752   
United States, Oklahoma
Lynn Health Science Institute Recruiting
Oklahoma City, Oklahoma, United States, 73112
Contact: Phyllis Fahrenhruch    405-602-3073   
Contact: Mark Fisher    405-602-3927   
United States, Pennsylvania
Penn State University College of Medicine/MS Hershey Medical Center Not yet recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Brenda Geiger, RN    717-531-7591   
Contact: Elizabeth Lucassen, MD    717-531-1804   
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Lindsay Liszewski    215-955-9575   
Contact: Thomas Leist, MD    215-955-6871   
United States, Tennessee
Neurology Clinic, P.C. Recruiting
Cordova, Tennessee, United States, 38018
Contact: Ye Liu, CCRC    901-866-9252   
Contact: Barbara Cape O'Brien, MD    901-747-1111   
United States, Texas
Future Search Trials of Neurology, LP Recruiting
Austin, Texas, United States, 78731
Contact: Natalie Hussung    512-380-9925   
Contact: John Hudson    512-380-9925   
Sponsors and Collaborators
Sun Pharma Advanced Research Company Limited
Study Director: Shravanti Bhowmik, MD Sun Pharma Advanced Research Centre Ltd, India
  More Information

No publications provided

Responsible Party: Sun Pharma Advanced Research Company Limited Identifier: NCT01457352     History of Changes
Other Study ID Numbers: CLR_09_21
Study First Received: October 17, 2011
Last Updated: April 23, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Multiple Sclerosis
Muscle Spasticity
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Muscle Hypertonia
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Manifestations
Signs and Symptoms processed this record on November 25, 2014