Revance to Showcase Phase 3 Results Evaluating DaxibotulinumtoxinA for Injection for the Treatment of Cervical Dystonia at the American Academy of Neurology Annual 2021 Virtual Meeting - Seite 2
In 2017, the U.S. Food and Drug Administration (FDA) granted orphan drug designation for DaxibotulinumtoxinA for Injection to treat cervical dystonia, which provides certain developmental and financial benefits to trial sponsors.
The company’s ASPEN Phase 3 clinical program consists of two trials to evaluate the safety and efficacy of DaxibotulinumtoxinA for Injection for the treatment of cervical dystonia in adults: 1) ASPEN-1, a randomized, double-blind, placebo-controlled, parallel group trial and 2) ASPEN-OLS, an open-label, long-term safety trial.
Randomized Trial (ASPEN-1): Patients were randomized to a single treatment of either 125 Unit or 250 Unit dose of DaxibotulinumtoxinA for Injection, or placebo. Post-treatment, patients are followed for a maximum of 36 weeks. The primary efficacy endpoint of the trial was the mean change from baseline in the TWSTRS Total Score at the average of Weeks 4 and 6. Key secondary endpoints include the duration of treatment effect, measurement of treatment response on the Clinical and Patient Global Impression of Change assessments, and adverse events. Further, the trial featured exploratory efficacy assessments including the Cervical Dystonia Impact Profile (CDIP-58), a disease-specific, patient-rated questionnaire that measures quality of life.
Open-Label Study (ASPEN-OLS): Patients receive up to four sequential treatment cycles of DaxibotulinumtoxinA for Injection over the 52-week observation period. Primary endpoints of the trial are safety and immunogenicity after multiple cycles of treatment with DaxibotulinumtoxinA for Injection. Key secondary endpoints are the change from baseline in TWSTRS Total Score and the duration of treatment effect, as well as overall treatment response based on the Clinical and Patient Global Impression of Change. The ASPEN-OLS trial is fully enrolled with a total of 354 patients at sites located in the United States, Canada, and Europe.
Additional information about the ASPEN Phase 3 program is available at www.clinicaltrials.gov.
About Cervical Dystonia
According to the Dystonia Medical Research Foundation, cervical dystonia is a painful and disabling chronic condition in which the neck muscles contract involuntarily, causing abnormal movements and awkward posture of the head and neck. The movements may be sustained (tonic), jerky (clonic), or a combination. Cervical dystonia (also referred to as spasmodic torticollis) may be primary (meaning that it is the only apparent neurological disorder, with or without a family history) or may be the result of secondary causes (such as physical trauma).