MS Patients with Spasticity Needed for Study of Extended-release Baclofen Capsules

Patricia Silva, PhD avatar

by Patricia Silva, PhD |

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MS clinical trial

A new clinical trial evaluating the effectiveness of extended-release baclofen capsules in relieving spasticity related to multiple sclerosis (MS) isĀ 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 GRSĀ distributes the drug’s active ingredients over time in a patient’s body, possiblyĀ 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 theĀ National Multiple Sclerosis Society, which spotlights this study on its website.

To take part, patientsĀ must be 18 or older and diagnosed with any form ofĀ MS, have a known history of spasticity, and may already be usingĀ baclofen in its current approved formulations.

Participants should have no clinical history of hypersensitivity to baclofen and noĀ previously treatment with intrathecal baclofen, a methodĀ that delivers the drugĀ 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 clinicĀ visits will be required.

Its primary endpoint is clinical improvement in the Ashworth Scale, a widely used measure of spasticity. Secondary goalsĀ will measure changes in spasm frequency, participant-reported spasm frequency, and nighttime awakening. (According to the company,Ā Baclofen GRS is designed to eliminate the need forĀ day- and night-time dosing, and to reduce the side effects related toĀ the drug’s peak concentration, especially its sedative effects.)

Doctor’s offices taking part in the study will beĀ in these cities: Long Beach and San Diego, California;Ā Aurora, Colorado;Ā Jacksonville, Miami,Ā Miami Springs,Ā Orlando, and Tampa,Ā Florida;Ā Charlotte, North Carolina;Ā Cleveland, Ohio; andĀ Richland, Washington.

Phase 3 trials of Baclofen GRS as a spasticity treatment are also being planned for the U.S., Sun Pharma states on its website.