Summary: Investigators nationwide are recruiting 200 people with any type of MS for a study comparing several doses of an investigational study drug, arbaclofen placarbil (AP), which is similar to a currently approved medication, baclofen, with inactive placebo. The study is funded by XenoPort, Inc.
Rationale: Spasticity refers to feelings of muscle stiffness, tightness, and involuntary muscle spasms (sustained muscle contractions or sudden movements). It is one of the more common symptoms for people with MS. Baclofen is the most commonly used drug to treat spasticity and is a muscle relaxant. AP is a new drug that has the same mechanism as baclofen. Baclofen has 2 components (R- and S-baclofen) and only one of these (R-baclofen) is responsible for improving spasticity. AP is a prodrug of R-baclofen, meaning after AP is taken orally your body changes it to R-baclofen. In a study in spinal cord injury (SCI) patients with spasticity, AP showed a significant and sustained anti-spasticity effect when AP was taken twice daily, therefore it is believed that AP may result in less frequent daily dosing (Nance PW, Huff FJ, Martinez-Arizala A, et al. Efficacy and safety study of Arbaclofen Placarbil in patients with spasticity due to SCI. Spinal Cord 2011).
Eligibility and Details: Participants must be aged 18 to 70, with definite MS and spasticity. If participants are taking a disease-modifying MS treatment, the dosage, frequency, and route of administration must be stable for at least 30 days before screening and are expected to be stable throughout the study. Further details on enrollment criteria are available via the contact information below.
Participants are being randomly assigned to receive three tablets, twice each day, containing either 15 mg, 30 mg, or 45 mg of AP, or inactive placebo, for 13 weeks. The primary outcomes being measured are improvement on the Ashworth scale, (which measures spasticity), and improvement on the patient’s impression of change. Secondary outcomes being measured include improvement of PRISM score, severity of pain associated with muscle spasm, and sleep quality.
Contact: To learn more about the enrollment criteria for this study, and to find out if you are eligible to participate, please visit www.CommandTrial.com, or the study listing on the National MS Society Web site.
