Action of Baclofen Capsules in Spasticity Due to Multiple Sclerosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by Sun Pharma Advanced Research Company Limited
Information provided by (Responsible Party):
Sun Pharma Advanced Research Company Limited Identifier:
First received: January 1, 2014
Last updated: December 5, 2015
Last verified: December 2015

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.

Condition Intervention Phase
Drug: Baclofen dose 1
Drug: Baclofen dose 2
Drug: Placebo
Phase 2

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

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Primary efficacy outcome: Improvement in total modified Ashworth score [ Time Frame: Day 24 ] [ Designated as safety issue: No ]
    Mean change from Baseline in total modified Ashworth score assessed over 24 hours

Secondary Outcome Measures:
  • Spasm frequency [ Time Frame: Day 24 ] [ Designated as safety issue: No ]
    Subject's assessment of their overall spasm frequency

  • Nighttime awakening score [ Time Frame: Day 24 ] [ Designated as safety issue: No ]
  • Clinical global impression of change [ Time Frame: Day 24 ] [ Designated as safety issue: No ]
  • Subject's global impression of change [ Time Frame: Day 24 ] [ Designated as safety issue: No ]

Estimated Enrollment: 135
Study Start Date: March 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Baclofen Dose1
The subjects will receive baclofen dose 1 for once a day oral administration
Drug: Baclofen dose 1
Subjects randomized to this arm will receive Baclofen dose 1
Other Name: Baclofen low dose
Active Comparator: Baclofen dose 2
The subjects will receive baclofen dose 1 for once a day oral administration
Drug: Baclofen dose 2
Subjects randomized to this arm will receive Baclofen dose 2
Other Name: Baclofen high dose
Placebo Comparator: Placebo
Placebo capsules
Drug: Placebo
Subjects will receive placebo capsules for once a day oral administration
Other Name: Placebo capsules

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


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

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
  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: NCT02027025

United States, California
Collaborative Neuroscience Network, Inc. Recruiting
Long Beach, California, United States, 90806
Contact: Nirav Patel    866-669-0234   
Contact: Minie Mercado    (562) 304-1742   
Pacific Research Network Inc Recruiting
San Diego, California, United States, 92103
Contact: Thomas Reilly    619-294-4302   
Contact: Misty Oto    (619) 294-4302   
United States, Colorado
University of Colorado Health Sciences Center Recruiting
Aurora, Colorado, United States, 80045
Contact: John Corboy    303-315-8760   
Contact: Nicola Haakonsen    (303) 724-6351   
United States, Florida
Jacksonville Center For Clinical Research Recruiting
Jacksonville, Florida, United States, 32216
Contact: Erin Doty    843-849-7382   
Contact: Gail Lowe    (904) 730-0101   
Ocean Blue Medical Research Center Inc Recruiting
Miami Springs, Florida, United States, 33166
Contact: Antonio Terrelonge    305-885-8983   
Contact: Yelamis Cartaya    (305) 885-8983   
Compass Research Active, not recruiting
Orlando, Florida, United States, 32806
Suncoast Neuroscience Associates Inc Active, not recruiting
Saint Petersburg, Florida, United States, 33713
Meridien Research Recruiting
Tampa, Florida, United States, 33634
Contact: Cynthia Huffman    813-877-8839   
Contact: Kristen Dewes    (813) 877-8839   
United States, Georgia
West Georgia Sleep Disorder Center and Neurology Associates Recruiting
Douglasville, Georgia, United States, 30134
Contact: Reginald Hall    404-788-8353   
Contact: Arnetria Dancy    (404) 788-8353   
United States, Kansas
University of Kansas Medical center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Sharon Lynch    913-588-6980   
Contact: Vonda Whitley    (913) 588-0080   
Midamerica Neuroscience Institute - Rowe Neurology Institute Recruiting
Lenexa, Kansas, United States, 66214
Contact: Vernon Rowe    913-894-1500 ext 155   
Contact: Shannon Cone    (913) 894-1500 ext 4260   
United States, Michigan
Quest Research Institute Recruiting
Bingham Farms, Michigan, United States, 48025
Contact: Aaron Ellenbogen    248-644-7770   
Contact: Linda Bardram    (248) 644-7770   
United States, North Carolina
Neurological Institute PA Recruiting
Charlotte, North Carolina, United States, 28204
Contact: T. Hemanth Rao    704-335-6483   
Contact: Samantha Cook    (704) 372-3714   
United States, Ohio
Rapid Medical Research Inc Recruiting
Cleveland, Ohio, United States, 44122
Contact: Mary Beth Manning    216-682-0320   
Contact: Sarah Dzigiel    (216) 337-3494   
United States, Washington
Zain Research LLC Recruiting
Richland, Washington, United States, 99352
Contact: Cheta Nand    314-825-1312   
Contact: Katlynn Moulton    (509) 420-5053   
Sponsors and Collaborators
Sun Pharma Advanced Research Company Limited
  More Information

Additional Information:
No publications provided

Responsible Party: Sun Pharma Advanced Research Company Limited Identifier: NCT02027025     History of Changes
Other Study ID Numbers: CLR_11_03 
Study First Received: January 1, 2014
Last Updated: December 5, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Sun Pharma Advanced Research Company Limited:
Spasticity, Multiple sclerosis

Additional relevant MeSH terms:
Muscle Spasticity
Multiple Sclerosis
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 February 10, 2016