Action of Baclofen Capsules in Spasticity Due to Multiple Sclerosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Sun Pharma Advanced Research Company Limited
Sponsor:
Information provided by (Responsible Party):
Sun Pharma Advanced Research Company Limited
ClinicalTrials.gov Identifier:
NCT02027025
First received: January 1, 2014
Last updated: July 3, 2014
Last verified: July 2014
  Purpose

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
Spasticity
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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 ClinicalTrials.gov identifier: NCT02027025

Locations
United States, California
Collaborative Neuroscience Network, Inc. Recruiting
Long Beach, California, United States, 90806
Contact: Nirav Patel    866-669-0234    niravpatel@cnstrial.com   
Contact: Anne Cabral    (866) 787-4257    annecabral@cnstrial.com   
Pacific Research Network Inc Recruiting
San Diego, California, United States, 92103
Contact: Thomas Reilly    619-294-4302    treillymd@gmail.com   
Contact: Dixie Creager    (619) 294-4302    dcreager@prnsd.com   
United States, Florida
Jacksonville Center For Clinical Research Recruiting
Jacksonville, Florida, United States, 32216
Contact: Erin Doty    843-849-7382    erindotymd@gmail.com   
Contact: Gail Lowe    (904) 730-0101    glowe@encoredocs.com   
Ocean Blue Medical Research Center Inc Recruiting
Miami Springs, Florida, United States, 33166
Contact: Antonio Terrelonge    305-885-8983    clinicaltrials@obmedresearch.com   
Contact: Yelamis Cartaya    (305) 885-8983    yelyc@obmedresearch.com   
Compass Research Recruiting
Orlando, Florida, United States, 32806
Contact: Ira Goodman    407-426-9299    ijgmd@aol.com   
Contact: Denise Davila    407 426-9299    ddavila@compassresearch.org   
Suncoast Neuroscience Associates Inc Recruiting
Saint Petersburg, Florida, United States, 33713
Contact: Alberto Vasquez    727-202-2623    abvmd@aol.com   
Contact: Natasha Wick    (727) 202-2623    nwick@suncoastneuroresearch.com   
United States, Kansas
Midamerica Neuroscience Institute - Rowe Neurology Institute Recruiting
Lenexa, Kansas, United States, 66214
Contact: Vernon Rowe    913-894-1500 ext 155    vrowe@neurokc.com   
Contact: Shannon Cone    (913) 894-1500 ext 4260    scone@neurokc.com   
United States, Michigan
Quest Research Institute Recruiting
Bingham Farms, Michigan, United States, 48025
Contact: Aaron Ellenbogen    248-644-7770    aaron@questri.com   
Contact: Linda Bardram    (248) 644-7770    linda@questri.com   
United States, North Carolina
Neurological Institute PA Not yet recruiting
Charlotte, North Carolina, United States, 28204
Contact: T. Hemanth Rao    704-372-3714    rao@neuro-institute.com   
Contact: Myrna Shrum    (704) 335-6483    mshrum@neuro-institute.com   
United States, Ohio
Rapid Medical Research Inc Recruiting
Cleveland, Ohio, United States, 44122
Contact: Mary Beth Manning    216-682-0320 ext 242    marybeth.manning@rapidmedicalresearch.com   
Contact: Kate Adler    (216) 682-0320    katie.adler@rapidmedicalresearch.com   
Sponsors and Collaborators
Sun Pharma Advanced Research Company Limited
  More Information

Additional Information:
No publications provided

Responsible Party: Sun Pharma Advanced Research Company Limited
ClinicalTrials.gov Identifier: NCT02027025     History of Changes
Other Study ID Numbers: CLR_11_03
Study First Received: January 1, 2014
Last Updated: July 3, 2014
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
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014