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Action of Baclofen Capsules in 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 dose 1 (Drug); Baclofen dose 2 (Drug); Placebo (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Sun Pharma Advanced Research Company Limited

Summary

This is a double-blind, randomized, placebo-controlled trial to evaluate duration of action of Baclofen ER capsules (GRS) compared with placebo in subjects with spasticity due to Multiple sclerosis. The trial will include male and female subjects greater than or equal to 18 years of age with spasticity with multiple sclerosis.

Clinical Details

Official title: A Double-Blind, Randomized, Placebo-Controlled, Parallel Group Trial to Evaluate the Duration of Action of Baclofen ER Capsules (GRS) in Subjects With Spasticity Due to Multiple Sclerosis (MS)

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

Primary outcome: Primary efficacy outcome: Improvement in total modified Ashworth score

Secondary outcome:

Spasm frequency

Nighttime awakening score

Clinical global impression of change

Subject's global impression of change

Detailed description: This clinical trial will be conducted in compliance with the Code of Federal Regulations of the United States of America, the guidance and rules of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), the Declaration of Helsinki, and all applicable regulatory requirements. This trial is designed to evaluate the duration of the anti-spasticity action of a single dose of Baclofen ER Capsules (GRS) administered in subjects with spasticity due to multiple sclerosis

Eligibility

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

Criteria:

Inclusion Criteria:

- Men and women greater than or equal to 18 years of age

- Willing to sign the informed consent form

- Women of child bearing potential willing to practice an acceptable method of birth

control

- Known history of spasticity due to MS

Exclusion Criteria:

- History of hypersensitivity to baclofen

- Treated with intrathecal baclofen prior to study

- Concomitant neurologic conditions causing spasticity

- Any medical condition, including psychiatric disease or epilepsy, which would

interfere with the interpretation of the trial results

Locations and Contacts

Collaborative Neuroscience Network, Inc., Long Beach, California 90806, United States; Recruiting
Nirav Patel, Phone: 866-669-0234, Email: niravpatel@cnstrial.com
Minie Mercado, Phone: (562) 304-1742, Email: miniemercadol@cnstrial.com

Pacific Research Network Inc, San Diego, California 92103, United States; Recruiting
Thomas Reilly, Phone: 619-294-4302, Email: treillymd@gmail.com
Misty Oto, Phone: (619) 294-4302, Email: moto@prnsd.com

University of Colorado Health Sciences Center, Aurora, Colorado 80045, United States; Recruiting
John Corboy, Phone: 303-315-8760, Email: john.corboy@ucdenver.edu
Nicola Haakonsen, Phone: (303) 724-6351, Email: nicola.haakonsen@ucdenver.edu

Jacksonville Center For Clinical Research, Jacksonville, Florida 32216, United States; Recruiting
Erin Doty, Phone: 843-849-7382, Email: erindotymd@gmail.com
Gail Lowe, Phone: (904) 730-0101, Email: glowe@encoredocs.com

Ocean Blue Medical Research Center Inc, Miami Springs, Florida 33166, United States; Recruiting
Antonio Terrelonge, Phone: 305-885-8983, Email: clinicaltrials@obmedresearch.com
Yelamis Cartaya, Phone: (305) 885-8983, Email: yelyc@obmedresearch.com

Compass Research, Orlando, Florida 32806, United States; Recruiting
Ira Goodman, Phone: 407-426-9299, Email: ijgmd@aol.com
Denise Davila, Phone: 407 426-9299, Email: ddavila@compassresearch.org

Suncoast Neuroscience Associates Inc, Saint Petersburg, Florida 33713, United States; Recruiting
Alberto Vasquez, Phone: 727-202-2623, Email: abvmd@aol.com
Natasha Wick, Phone: (727) 202-2623, Email: nwick@suncoastneuroresearch.com

Meridien Research, Tampa, Florida 33634, United States; Recruiting
Cynthia Huffman, Phone: 813-877-8839, Email: chuffman@meridienresearch.net
Kristen Dewes, Phone: (813) 877-8839, Email: kdewes@meridienresearch.net

West Georgia Sleep Disorder Center and Neurology Associates, Douglasville, Georgia 30134, United States; Recruiting
Reginald Hall, Phone: 404-788-8353, Email: medicalresearchsolutions@gmail.com
Arnetria Dancy, Phone: (404) 788-8353, Email: arnetriaandjohn@gmail.com

University of Kansas Medical center, Kansas City, Kansas 66160, United States; Recruiting
Sharon Lynch, Phone: 913-588-6980, Email: slynch@kumc.edu
Vonda Whitley, Phone: (913) 588-0080, Email: vwhitley@kumc.edu

Midamerica Neuroscience Institute - Rowe Neurology Institute, Lenexa, Kansas 66214, United States; Recruiting
Vernon Rowe, Phone: 913-894-1500, Ext: 155, Email: vrowe@neurokc.com
Shannon Cone, Phone: (913) 894-1500, Ext: 4260, Email: scone@neurokc.com

Quest Research Institute, Bingham Farms, Michigan 48025, United States; Recruiting
Aaron Ellenbogen, Phone: 248-644-7770, Email: aaron@questri.com
Linda Bardram, Phone: (248) 644-7770, Email: linda@questri.com

Neurological Institute PA, Charlotte, North Carolina 28204, United States; Recruiting
T. Hemanth Rao, Phone: 704-335-6483, Email: rao@neuro-institute.com
Samantha Cook, Phone: (704) 372-3714, Email: scook@neuro-institute.com

Rapid Medical Research Inc, Cleveland, Ohio 44122, United States; Recruiting
Mary Beth Manning, Phone: 216-682-0320, Ext: 242, Email: marybeth.manning@rapidmedicalresearch.com
Sarah Dzigiel, Phone: (216) 337-3494, Email: sarah.dzigiel@rapidmedicalresearch.com

Zain Research LLC, Richland, Washington 99352, United States; Recruiting
Cheta Nand, Phone: 314-825-1312, Email: research@zaimur.com
Katlynn Moulton, Phone: (509) 420-5053, Email: katlynn.moulton@zaimur.com

Additional Information

The website contains a health questionnaire which identifies if the patients are eligible to participate in the MS study that is going on in many locations

Starting date: March 2014
Last updated: July 3, 2015

Page last updated: August 20, 2015

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