A new clinical trial evaluating the effectiveness of extended-release baclofen capsules in relieving spasticity related to multiple sclerosis (MS) is calling for 135 people with any form of the disease. The study, taking place in six U.S. states, is sponsored by Sun Pharma, the drug’s developer.
Baclofen, an approved MS treatment available in different forms, acts as a muscle relaxer and an antispastic agent. As an extended-release treatment, Baclofen GRS distributes the drug’s active ingredients over time in a patient’s body, possibly allowing for less frequent dosing than is now common.
Spasticity refers to feelings of stiffness, and a wide range of involuntary muscle spasms, and is one of the more common symptoms of MS, according to the National Multiple Sclerosis Society, which spotlights this study on its website.
To take part, patients must be 18 or older and diagnosed with any form of MS, have a known history of spasticity, and may already be using baclofen in its current approved formulations.
Participants should have no clinical history of hypersensitivity to baclofen and no previously treatment with intrathecal baclofen, a method that delivers the drug directly to the intrathecal space (area of the spine) via a surgically implanted infusion pump and catheter.
Trial investigators will randomize participants to oral daily treatment with extended-release high-dose baclofen, low-dose baclofen, or placebo, for about 25 days. The trial, called Basis, lasts for 46 days, and three clinic visits will be required.
Its primary endpoint is clinical improvement in the Ashworth Scale, a widely used measure of spasticity. Secondary goals will measure changes in spasm frequency, participant-reported spasm frequency, and nighttime awakening. (According to the company, Baclofen GRS is designed to eliminate the need for day- and night-time dosing, and to reduce the side effects related to the drug’s peak concentration, especially its sedative effects.)
Doctor’s offices taking part in the study will be in these cities: Long Beach and San Diego, California; Aurora, Colorado; Jacksonville, Miami, Miami Springs, Orlando, and Tampa, Florida; Charlotte, North Carolina; Cleveland, Ohio; and Richland, Washington.
More information about this trial, and how to participate, can be found on the trial’s website at www.basisstudy.com.
Phase 3 trials of Baclofen GRS as a spasticity treatment are also being planned for the U.S., Sun Pharma states on its website.