Injectable DaxibotulinumtoxinA in Cervical Dystonia: A Phase 2 Dose-Escalation Multicenter Study.

ABSTRACT:

Background

Injectable daxibotulinumtoxinA (an investigational botulinum toxin, RT002) may offer a more prolonged duration of response-and therefore less frequent dosing-than onabotulinumtoxinA.

Objectives

To perform a phase 2, open-label, dose-escalation study to assess the efficacy and safety of daxibotulinumtoxinA in cervical dystonia.

Methods

Subjects with moderate-to-severe isolated cervical dystonia were enrolled in sequential cohorts to receive a single open-label, intramuscular dose of injectable daxibotulinumtoxinA of up to 200 U (n = 12), 200-300 U (n = 12), or 300-450 U (n = 13; https://clinicaltrials.gov identifier NCT02706795).

Results

Overall, 33/37 enrollees completed the trial. DaxibotulinumtoxinA was associated with mean red

SUBMITTER: Jankovic J 

PROVIDER: S-EPMC6032882 | biostudies-literature | 2018 May-Jun

REPOSITORIES: biostudies-literature