SAN ANTONIO (May 21, 2015) — For people who have been diagnosed with a neurological disorder that weakens the throat muscles and tongue, troublesome drooling – known in the medical world as sialorrhea – is a common but psychologically devastating condition.
Local residents suffering from this condition may be eligible to enroll in a Phase 3 research study being conducted by the Department of Neurology at The University of Texas Health Science Center at San Antonio. This study will evaluate the effectiveness and the safety of MYOBLOC®, which is a botulinum toxin type B injection. Botulinum toxin is most commonly used for the cosmetic treatment of wrinkles.
MYOBLOC® was approved by the FDA for the treatment of cervical dystonia, which is a disorder characterized by involuntary muscle contractions of the neck and shoulder.
To participate in this study, patients must be between the ages of 18 and 85, seeking treatment for troublesome drooling for at least three months (drooling must be secondary or related to another cause), and have had no prior exposure to botulinum toxin to the salivary glands.
Carlayne E. Jackson, M.D., professor of neurology at the UT Health Science Center and principal investigator for the local study, said this is the second trial of this treatment in San Antonio.
“The first trial was solely for patients with Amyotrophic Lateral Sclerosis or ALS. We showed this drug was dramatically effective. It was a small research study with only three centers and 20 patients. This current study is much larger, and it is not just for ALS patients. It is for anyone with a neurological disease that weakens the throat muscles and tongue,” she explained.
The Department of Neurology’s clinic in San Antonio is one of 26 centers in the United States participating in this study. Sponsored by Solstice Neurosciences, LLC and US WorldMeds, LLC, the goal is to enroll approximately 180 patients across the country.
Dr. Jackson said those who have suffered a stroke or traumatic brain injury or who have been diagnosed with ALS, Parkinson’s disease, cerebral palsy or multiple sclerosis may be eligible to participate in the study.
“Those who enroll in the study will have a small injection in two of the major salivary glands – which are called the parotid and the submandibular glands. The first dose could be a placebo, a low dose or a high dose.
“This is a double-blind, placebo-controlled single-treatment study that is followed by an open-label, multiple treatment study with MYOBLOC®. After they complete the 12-week study, participants can receive up to five doses free of the injection,” she said.
This study is important because “we are trying to prove the efficacy and safety of the drug for sialorrhea in hopes of the FDA approving it for this use. Then, it will be covered by insurance. At this time, the injections are very expensive. Each injection can cost $800. Many insurance companies won’t cover it, and many people cannot afford it,” Dr. Jackson added.
For information on enrolling in the study, contact Pamela Kittrell, M.S.N., RN, at 210-450-0524 or kittrellp@uthscsa.edu.
The University of Texas Health Science Center at San Antonio, one of the country’s leading health sciences universities, ranks in the top 13 percent of academic institutions receiving National Institutes of Health (NIH) funding. The university’s schools of medicine, nursing, dentistry, health professions and graduate biomedical sciences have produced more than 31,000 graduates. The $787.7 million operating budget supports eight campuses in San Antonio, Laredo, Harlingen and Edinburg. For more information on the many ways “We make lives better®,” visit www.uthscsa.edu.