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.