Multiple Sclerosis Study Seeking 1,200 Participants
A new study that will evaluate the effectiveness of an experimental oral drug (RPC1063) and Avonex (interferon beta-1a) in individuals with relapsing multiple sclerosis is now recruiting participants. The effort, which is known as the Sunbeam Study, is funded by Receptos, Inc., which makes the experimental drug.
Currently, dozens of sites throughout the United States are recruiting participants, and scores more will be available soon in the states and around the world. Additional information about the participating sites can be seen on the clinicaltrials.gov website.
RPC1063 is a selective sphingosine 1-phosphate receptor modulator, which means it was designed to prevent certain white blood cells located in the lymph nodes from traveling into the central nervous system. Avonex is a disease-modifying drug often prescribed for individuals with relapsing MS. It is composed of the same protein components (amino acids) found in the human body.
The new study is a phase 3 trial in which participants will be given either Avonex or one of two doses (1 mg or 5 mg) of RPC1063. In a previous phase 2 trial, the investigators found that the number of MRI lesions in 258 participants with relapsing MS were reduced by 86 percent among those taking RPC1063 in two study arms when compared with placebo.
The primary outcome to be assessed in this study is the relapse rate at one year. Secondary outcomes will include changes in the MS Functional Composite (which measures progression of the disease), MRI scans, volume of brain tissue lost, visual function, time to sustained disease progression, and quality of life.
Study participants must be between the ages of 18 and 55 and have had at least one documented relapse during the previous 12 months. However, if the relapse occurred within the last two years, an MRI performed during the past year should provide evidence of at least one brain lesion.
Other qualifications and additional information about this phase 3 study can be seen at the Sunbeam Study website. The site leads you to a questionnaire to see if you qualify plus details about study requirements and procedures.