A Study to Evaluate Intramuscular ABP-450 (PrabotulinumToxinA) Injection for the Treatment of Cervical Dystonia (H-49432)
The purpose of this study, which involves research, is to determine whether an investigational study drug,
ABP-450 (prabotulinumtoxinA) is safe and effective for treating cervical dystonia, compared with placebo. ABP-450 (prabotulinumtoxinA) is a toxin produced by Clostridium botulinum. This toxin has been used in small amounts by doctors to treat health problems. In this study, ABP-450 is being tested in people who have a clinical diagnosis of cervical dystonia. ABP-450 has been tested previously in rats and dogs, and the results have shown that ABP-450 can be a possible treatment for cervical dystonia. The placebo looks like the investigational study drug, ABP-450, but does not contain any active substance.
Researchers often use placebo to see if an investigational study drug works and is safe.
Approximately 60 participants are expected to be enrolled in this study at approximately 42 study sites in the United States. The participants will be grouped into 4 groups (15 participants in each group). Participants will receive 150 units of ABP-450, 250 units of ABP-450, 350 units of ABP-450, or placebo depending on the group they are assigned to.