SLU Researchers Enroll Patients in Clinical Trial to Test Botulinum Toxin for Rare Neurologic Disorder
As a part of a multi-center, phase 3 clinical trial, Saint Louis University (SLU) is enrolling participants in a study to examine the safety and efficacy of a new type of botulinum toxin, called daxibotulinumtoxinA (commonly known as DAXI), for a chronic neurologic disorder.
Isolated cervical dystonia (CD) is a rare, painful condition in which the neck muscles involuntarily contract, causing the head, neck and shoulders to move abnormally. CD can occur at any age, though it most often affects people in middle age and it afflicts women more often than men. Doctors usually cannot pinpoint a cause, though head, neck or shoulder injuries and family history may play a role.
Currently, a form of botulinum toxin injection is used to treat CD, and it provides benefits for around three months. This clinical trial will study DAXI for injection, a new form of botulinum toxin, to evaluate whether the effect of the study drug is able to last longer than the standard treatment and still be safe.
Pratap Chand, M.D., professor of neurology at Saint Louis University and lead researcher of the study, says the trial will evaluate a single injection of DAXI for injection to patients’ affected muscles.
“Cervical dystonia is a painful condition that diminishes quality of life for patients,” said Chand, who also is a SLUCare neurologist. “This study aims to find new treatment options that can offer longer lasting relief to those with CD.”
The randomized, double-blind, placebo-controlled study will enroll 300 participants at around 80 centers in the U.S., Canada and Europe who are between 18 and 80 years old and who have been diagnosed with at least moderate severity CD. Participants will be assigned to receive either one dose of the study drug or a placebo.
After receiving the study drug or placebo, participants will continue to be evaluated to judge their response to the injection for up to 36 weeks.
To learn more about the study, please contact Susan Eller at 314-977-4867.
Saint Louis University School of Medicine
Established in 1836, Saint Louis University School of Medicine has the distinction
of awarding the first medical degree west of the Mississippi River. The school educates
physicians and biomedical scientists, conducts medical research, and provides health
care on a local, national and international level. Research at the school seeks new
cures and treatments in five key areas: cancer, liver disease, heart/lung disease,
aging and brain disease, and infectious diseases.