MS Trial Alert: Investigators Recruiting People with MS and Spasticity for a Study of Extended-Relea - National Multiple Sclerosis Society

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MS Trial Alert: Investigators Recruiting People with MS and Spasticity for a Study of Extended-Release Baclofen

April 1, 2014

Summary: Investigators nationwide are recruiting 214 people for a study to determine the effectiveness of extended-release baclofen capsules in relieving spasticity and symptoms related to MS. The study is sponsored by Sun Pharma Advanced Research Company Limited.

Rationale: Spasticity refers to feelings of stiffness and a wide range of involuntary muscle spasms (sustained muscle contractions or sudden movements). It is one of the more common and troublesome symptoms of MS. Baclofen acts on the central nervous system to relieve spasms, cramping, and tightness of muscles caused by spasticity. This study is evaluating an extended-release form of baclofen. Extended release – in which a drug is released over time – may allow for it to be taken less often.

Eligibility and Details: Participants should be at least 18 years old, have any form of MS and a known history of spasticity. Participants should be taking immediate-release baclofen (30 to 60 mg) at the same dose and the same schedule for the last 30 days. Further details on enrollment criteria are available from the contact below.

Participants will receive baclofen immediate release capsules daily for one week, and then extended-release capsules daily for up to 16 weeks (doses will increase from 10 to 60 mg). Then participants will be randomly chosen to receive either the investigational drug or an inactive placebo for up to an additional 4 weeks. The dosage will gradually decrease during these 4 weeks.

The primary outcomes being measured are how many participants are able to complete the study, and safety.

Contact: To learn more about the enrollment criteria for this study, and to find out if you are eligible to participate, please contact the site nearest you. The potential subjects should go to the study investigator list at ClinicalTrials.gov to receive contact information for the nearest study site.

Sites are going to be recruiting in the following cities:
Gilbert, Arizona
Tucson, Arizona
Derby, Connecticut
New London, Connecticut
Washington, District of Columbia
Bradenton, Florida
Miami, Florida
Ormond Beach, Florida
Atlanta, Georgia
Lenexa, Kansas
Louisville, Kentucky
Baltimore, Maryland
Columbia, Missouri
Rochester, New York
White Plains, New York
Chapel Hill, North Carolina
Winston-Salem, North Carolina
Grand Forks, North Dakota
Columbus, Ohio
Oklahoma City, Oklahoma
Hershey, Pennsylvania
Philadelphia, Pennsylvania
Cordova, Tennessee
Austin, Texas

Download a brochure that discusses issues to think about when considering enrolling in an MS clinical trial (PDF).
 

About Multiple Sclerosis

Multiple sclerosis, an unpredictable, often disabling disease of the central nervous system, interrupts the flow of information within the brain, and between the brain and body. Symptoms range from numbness and tingling to blindness and paralysis. The progress, severity and specific symptoms of MS in any one person cannot yet be predicted, but advances in research and treatment are moving us closer to a world free of MS. Most people with MS are diagnosed between the ages of 20 and 50, with at least two to three times more women than men being diagnosed with the disease. MS affects more than 2.3 million people worldwide.

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