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

Information source: Sun Pharma Advanced Research Company Limited
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Spasticity

Intervention: Baclofen ER Capsules (Drug); Placebo GRS (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Sun Pharma Advanced Research Company Limited

Official(s) and/or principal investigator(s):
Shravanti Bhowmik, MD, Study Director, Affiliation: Sun Pharma Advanced Research Centre Ltd, India

Overall contact:
Shravanti Bhowmik, MD, Phone: +9122 66455645, Ext: 5626, Email: Shravanti.Bhowmik@sparcmail.com

Summary

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

Clinical Details

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

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

Primary outcome:

The primary efficacy outcome is the proportion of subjects who become a treatment failure during double-blind randomized withdrawal

Determining the safety profile when administered over >12 weeks

Secondary outcome: Subject Global Impression of Severity (SGIS)assessment

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Shravanti Bhowmik, MD, Phone: +9122 66455645, Ext: 5626, Email: Shravanti.Bhowmik@sparcmail.com

Neurological Physicians of Arizona/Clinical Research Advantage, Gilbert, Arizona 85234, United States; Recruiting
Leslie Munson, CCRC, Phone: 480-610-0177, Email: leslie.munson@crastudies.com
William Grainger, MD, Phone: 480-305-5716, Email: wgrainger@crastudies.com

NNS Clinical Research, LLC, Tucson, Arizona 85741, United States; Recruiting
Karma Hale, RN, Phone: 520-742-1833, Ext: 104, Email: khale@nnsresearch.com
Jeanette Wendt, MD, Phone: 520-742-1833, Email: jwendt@nnsresearch.com

CITrials, Inc., Costa Mesa, California 92626, United States; Not yet recruiting
Debra Hoffmeyer, Phone: 714-979-4101, Email: debra@citrials.com
Merhdad Mahdad, MD, Phone: 714-979-4101, Email: Mahdad@citrials.com

MS Center of California, Newport Beach, California 92663, United States; Recruiting
Erin O'Carroll-Godinez, MPH, Phone: 949-631-2917, Email: erin@nbneuro.com
Daniel Bandari, MD, Phone: 949-631-2917, Email: dbandari@mscscal.com

Mountain View Clinical Research, Inc., Denver, Colorado 80209, United States; Recruiting
Brian Johnson, Phone: 720-941-9363, Email: B.Johnson@mtnviewclinicalresearch.com
Bennett Machanic, MD, Phone: 720-941-9363, Email: mtnviewresearch@aol.com

Advanced Neurosciences Research, LLC, Fort Collins, Colorado 80528, United States; Recruiting
Lillie Denny, Phone: 970-381-6667, Email: denny.lillie@hotmail.com
Tamara Miller, MD, Phone: 970-226-6111, Email: tamara.miller@advancedneurology.com

Multiple Sclerosis Treatment Center, Derby, Connecticut 06418, United States; Recruiting
Cheryl Michaud, Phone: 203-732-1290, Email: mstc@griffinhealth.org
Joseph Guarnaccia, MD, Phone: 203-732-1290, Email: mstreatmentcenters@griffinhealth.org

Coastal Connecticute Research, LLC, New London, Connecticut 06320, United States; Recruiting
Carol Alexandrescu, LPN, Phone: 860-437-7092, Email: carol@ccrstudies.com
Laurence Radin, MD, Phone: 860-437-7092, Email: jessie@ccrstudies.com

Georgetown University Hospital, Washington, District of Columbia 20007, United States; Recruiting
Lauren Essler, Phone: 202-444-4289, Email: lee37@georgetown.edu
Carlo Tornatore, MD, Phone: 202-444-2658, Email: tornatoc@gunet.georgetown.edu

Bradenton Research Center, Inc., Bradenton, Florida 34205, United States; Recruiting
Erin Francis, LPN, Phone: 941-708-0005, Ext: 13, Email: erinfrancis@bradentonresearch.com
William McElveen, MD, Phone: 941-708-0005, Email: cebmce@hotmail.com

University of Florida Health Science Center, Jacksonville, Florida 32209, United States; Recruiting
Judy Bulacan, MPH, Phone: 904-244-9737, Email: Judy.Bulacan@jax.ufl.edu
Kalina Sanders, MD, Phone: 904-244-9856, Email: kalina.sanders@jax.ufl.edu

Advanced Medical Pain Management & Research Clinic, Miami, Florida 33145, United States; Withdrawn

University of Miami/Miller School of Medicine, Miami, Florida 33136, United States; Recruiting
Gloria Rodriguez, Phone: 305-243-8052, Email: g.rodriguez8@med.miami.edu
Silvia Delgado, MD, Phone: 305-243-6732, Email: Sdelgado1@med.miami.edu

Neurology Associates of Ormond Beach, Ormond Beach, Florida 32174, United States; Recruiting
Sandra Geyer, CCRC, Phone: 386-673-2500, Ext: 248, Email: neurosgeyer@yahoo.com
James Scott, MD, PhD, Phone: 386-673-2500, Ext: 248, Email: neurojscott@yahoo.com

Neurostudies, Inc., Port Charlotte, Florida 33952, United States; Recruiting
Vicky Thursby, Phone: 941-743-1027, Email: research@myneurologypa.com
Liliana Montoya, MD, Phone: 941-743-1027, Email: neurostudies4@daystar.net

Lovelace Scientific Resources, Inc., Sarasota, Florida 34233, United States; Recruiting
Kimberly Dupage, RN,BSN,CCRC,CHRC, Phone: 941-485-8314, Email: kdupage@lrri.org
Ronald Aung-Din, MD, Phone: 941-379-8810, Email: aungdinmd@verizon.net

Infinity Clinical Research, LLC, Sunrise, Florida 33351, United States; Recruiting
Michele Fistel, CCRC, Phone: 954-738-1697, Email: mfistel@infinityclinicalresearch.com
Brian Steingo, MD, Phone: 954-738-1696, Email: bsteingo@infinityclincialresearch.com

University of South Florida, Tampa, Florida 33612, United States; Recruiting
Angela Aungst, Phone: 813-974-6378, Email: aaungst@health.usf.edu
Derrick Robertson, MD, Phone: 813-974-6378, Email: droberts@health.usf.edu

Emory University, Atlanta, Georgia 30329, United States; Recruiting
Kanoa Folami, Phone: 404-778-3772, Email: kfolami@emory.edu
Neil Lava, MD, Phone: 404-778-3444, Email: nlava@emory.edu

Shepherd Center, Atlanta, Georgia 30309, United States; Withdrawn

Indiana University, Indianapolis, Indiana 46202, United States; Withdrawn

Rowe Neurology Institute, Lenexa, Kansas 66214, United States; Recruiting
Leigh Kreshel, MS, Phone: 913-894-1500, Email: lkreshel@neurokc.com
Vernon Rowe, III, MD, Phone: 913-894-1500, Email: vrowe@neurokc.com

Overland Park Surgical Specialties Neurology, Overland Park, Kansas 66212, United States; Recruiting
Kristen Giese, Phone: 913-469-9887, Email: kgiese@cpfcc.net
Jeffrey Kaplan, MD, Phone: 913-438-0868, Email: jmkaplan@cpfcc.net

Norton Neurology MS Services, Louisville, Kentucky 40207, United States; Recruiting
Diana Godwin, RN, Phone: 502-899-6782, Email: diana.godwin@nortonhealthcare.org
Robert Tillet Jr., MD, Phone: 502-899-6782, Email: rtilletjr@gmail.com

The Neuromedical Center Clinic, Baton Rouge, Louisiana 70810, United States; Recruiting
Jan Loyacano, Phone: 225-761-2569, Email: jloyacano@intrafusion.com
April Erwin, MD, Phone: 225-769-2200, Email: aprilerwin@yahoo.com

Ochsner/Baptist Clinic Foundation, New Orleans, Louisiana 70121, United States; Recruiting
Nawar Hussin, Phone: 504-842-6726, Email: nawar.hussin@ochsner.org
Bridget Bagert, MD, Phone: 504-842-3980, Email: bbagert@ochsner.org

Johns Hopkins, Baltimore, Maryland 21287-6985, United States; Withdrawn

Maryland Pain and Spine Center, LLC, Fulton, Maryland 20759, United States; Recruiting
Latasha Spencer, LPN, Phone: 240-547-4563, Email: lspencer@intrafusion.com
Ruwani Gunawardane, MD, Phone: 240-547-4563, Email: vrpg@verizon.net

Neuro Institute of New England PC, Foxboro, Massachusetts 02035, United States; Not yet recruiting
Sarah Cardoso, Phone: 781-551-5812, Email: sarahbensoncardoso@gmail.com
Salvatore Napoli, MD, Phone: 781-551-5812, Email: sqnapoli@gmail.com

Springfield Neurology Associates, Springfield, Massachusetts 01104, United States; Recruiting
Larrissa McGovern, LPN, CCRC, Phone: 413-781-5045, Email: larissamcgovern@springfieldneuro.com
Michael Rossen, MD, Phone: 413-781-5045, Email: mrossen13@gmail.com

Michigan Neurology Associates, Clinton Twp., Michigan 48035, United States; Recruiting
Brittany Egle, Phone: 586-464-2026, Email: begle@mnapc.org
Thomas Giancarlo, MD, Phone: 586-464-2026, Email: tgiancarlo@mnapc.org

Henry Ford Health System, Department of Neurology, Detroit, Michigan 48202, United States; Recruiting
Jackie Reuther, RN, CCRC, Phone: 313-916-1906, Email: jreuthe1@hfhs.org
Mirela Cerghet, MD, PhD, Phone: 313-916-7207, Email: mcerghe1@hfhs.org

Minneapolis Clinic of Neurology, Golden Valley, Minnesota 55422, United States; Recruiting
Neha Goyal, Phone: 763-302-4072, Email: neha.goyal@mpls-clinic.com
Gary Birnbaum, MD, Phone: 763-588-0661, Email: birnb001@umn.edu

University of Missouri Department of Physical Medicine and Rehabilitation, Columbia, Missouri 65212, United States; Withdrawn

University of Nebraska Medical Center (UNMC) Neurological Sciences, Omaha, Nebraska 68198-2045, United States; Recruiting
Jeanne Welte, MSN,RN, Phone: 402-559-5955, Email: jeanne.welte@unmc.edu
Rana Zabad, MD, Phone: 402-559-5569, Email: rzabad@unmc.edu

Hunterdon Neurology, PA, Flemington, New Jersey 08822, United States; Not yet recruiting
Kristen Cornell, RN, CRC, Phone: 908-751-4984, Email: kcornell@intrafusion.com
Dipakkumar Pandya, MD, Phone: 908-751-4985, Email: dipakpandya@gmail.com

Lovelace Scientific Resources, Inc., Albuquerque, New Mexico 87108, United States; Recruiting
Leslie Byatt, CCRC, Phone: 505-348-9500, Email: lbyatt@lrri.org
Michael McGuire, MD, Phone: 505-348-9500, Email: mmcguire@lrri.org

University of Rochester, Rochester, New York 14642, United States; Recruiting
Eileen Scheid, RN, Phone: 585-275-6673, Email: eileen_scheid@urmc.rochester.edu
Andrew Goodman, MD, Phone: 585-275-7854, Email: andrew_goodman@urmc.rochester.edu

Burke Rehabilitation Hospital, White Plains, New York 10605, United States; Withdrawn

University of North Carolina at Chapel Hill Department of Neurology, Chapel Hill, North Carolina 27599, United States; Withdrawn

Guilford Neurologic Associates, Inc., Greensboro, North Carolina 27405, United States; Recruiting
Amy Riddle, RN, MHA, Phone: 336-273-2511, Ext: 102, Email: Amy.Riddle@conehealth.com
Yijun Yan, MD, Phone: 336-478-2484, Email: yijun.yan@conehealth.com

PMG Research of Winston-Salem, Winston-Salem, North Carolina 27103, United States; Recruiting
Gabriela Jimenez, Phone: 336-768-8062, Email: gjimenez@pmg-research.com
Mitchell Isaac, MD, Phone: 336-794-8165, Email: Mitchell.Isaac@pmg-research.com

Altru Health System/Altru Clinic-Main, Grand Forks, North Dakota 58201, United States; Withdrawn

Neurology & Associates, Inc., Akron, Ohio 44320, United States; Recruiting
Patricia Schisler, LPN, CCRC, Phone: 330-572-1011, Email: pschisler@nnadoc.com
Jose Rafecas, MD, Phone: 330-572-1011, Email: jrafecas@nnadoc.com

Dayton Center for Neurological Disorders, Centerville, Ohio 45459, United States; Recruiting
Wendy Thacker, LPN, Phone: 937-424-3033, Email: wthacker@dcndinc.com
Kenneth Mankowski, DO, Phone: 937-424-3033, Email: ken@msinstitute.net

The Ohio State University Medical Center, Cramblett Medical Clinic, Columbus, Ohio 43221, United States; Recruiting
Misty regula, Phone: 614-293-6486, Email: misty.regula@osumc.edu
Michael Racke, MD, Phone: 614-366-3752, Email: Michael.Racke@osumc.edu

Lynn Health Science Institute, Oklahoma City, Oklahoma 73112, United States; Withdrawn

OMRF MS Center of Excellence, Oklahoma City, Oklahoma 73104, United States; Recruiting
Micki Moore, Phone: 405-271-6241, Email: micki-moore@omrf.org
Gabriel Pardo, MD, Phone: (405) 271 6241, Email: gabriel-pardo@omrf.org

Abington Neurological Associates, Abington, Pennsylvania 19090, United States; Recruiting
Carolyn Palumbo, Phone: 215-957-9250, Email: cep679@gmail.com
David Weisman, MD, Phone: 215-957-9250, Email: dcweisman@gmail.com

Penn State University College of Medicine/MS Hershey Medical Center, Hershey, Pennsylvania 17033, United States; Recruiting
Jennifer Crossen, BS, Phone: 717-531-0003, Ext: 289860, Email: jcrossen@hmc.psu.edu
Elizabeth Lucassen, MD, Phone: 717-531-1804, Email: elucassen@hmc.psu.edu

Temple University School of Medicine, Philadelphia, Pennsylvania 19140, United States; Recruiting
Lindsey Colman, Phone: 215-707-3193, Email: Lindsey.Colman@tuhs.temple.edu
S. Ausim Azizi, Ph.D, MD, Phone: 215-707-3040, Email: Ausim.Azizi@tuhs.temple.edu

Thomas Jefferson University, Philadelphia, Pennsylvania 19107, United States; Withdrawn

Metrolina Neurological Associates, PA Neurology, Indian Land, South Carolina 29707, United States; Recruiting
Melanie Boyd, RN,CRC, Phone: 803-878-2166, Email: mboyd@intrafusion.com
Howard Mandell, MD, Phone: 803-878-2166, Email: jess1236@rhtc.net

Neurology Clinic, P.C., Cordova, Tennessee 38018, United States; Withdrawn

Future Search Trials of Neurology, LP, Austin, Texas 78731, United States; Recruiting
Kevin Ford, Phone: 512-380-9925, Email: kevinf@fstrials.com
John Hudson, MD, Phone: 512-380-9925, Email: jdh@sleepdoc.net

Baylor Research Institute / MS Treatment Center of Dallas, Dallas, Texas 75246, United States; Recruiting
Portland Pleasant, RN, Phone: 214-820-7903, Email: Portland.Pleasant@baylorhealth.edu
Annette Okai, MD, Phone: 214-820-4655, Email: Annette.Okai@baylorhealth.edu

Multicare Institute for Research and Innovations, Tacoma, Washington 98405, United States; Recruiting
Jarrod Monroe, Phone: 253-403-7449, Email: jarrod.monroe@multicare.org
John Huddlestone, MD, Phone: 253-403-7440, Email: john.huddlestone@multicare.org

Marshall University, Huntington, West Virginia 25701, United States; Recruiting
Linda Morgan, RN, BSN, Phone: 304-691-1213, Email: lsmorgan@marshall.edu
Paul Ferguson, MD, Phone: 304-691-1762, Email: paul.ferguson@marshall.edu

Wheaton Franciscan Heatlhcare-St. Francis Center of Neurological Disorders Outpatient Center, Milwaukee, Wisconsin 53215, United States; Recruiting
Tayo Olapo, Phone: 414-769-4012, Email: tayo.olapo@wfhc.org
Christopher Cronsell, MD, Phone: 414-769-4012, Email: ccronsel@mcw.edu

Cardiovascular & Neurosciences Research Institute, ProHealth Care, Inc, Waukesha, Wisconsin 53188, United States; Recruiting
Kari Marconnett, MPH, RN, Phone: 262-928-7637, Email: kari.marconnet@phci.org
Stanya Smith, MD, Phone: 262-928-7637, Email: ssmith@neurologicltd.com

Additional Information

Starting date: September 2012
Last updated: April 28, 2015

Page last updated: August 20, 2015

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