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Measurement & Analysis of the Temporal Discrimination Threshold Applied to Cervical Dystonia
Published on: January 27, 2018
Injectable DaxibotulinumtoxinA in Cervical Dystonia: A Phase 2 Dose-Escalation Multicenter Study
Joseph Jankovic1, Daniel Truong2, Atul T Patel3
1Parkinson's Disease Center and Movement Disorders Clinic Department of Neurology, Baylor College of Medicine Houston TX.
DaxibotulinumtoxinA shows promise for treating cervical dystonia, offering prolonged efficacy and a good safety profile. This investigational botulinum toxin may require less frequent dosing than current treatments.
Area of Science:
- Neurology
- Pharmacology
Background:
- Investigational injectable daxibotulinumtoxinA (RT002) may provide longer-lasting effects than onabotulinumtoxinA.
- This could potentially reduce dosing frequency for patients.
Purpose of the Study:
- To assess the efficacy and safety of daxibotulinumtoxinA in patients with cervical dystonia.
- A phase 2, open-label, dose-escalation study was conducted.
Main Methods:
- 37 participants with moderate-to-severe cervical dystonia received single intramuscular doses of daxibotulinumtoxinA.
- Doses ranged from up to 200 U to 300-450 U across sequential cohorts.
Main Results:
- DaxibotulinumtoxinA demonstrated significant reductions in cervical dystonia symptoms, with a mean TWSTRS-Total score reduction of 50% at week 6.
- 94% of subjects were responders at week 6, and 68% at week 24.
- The median duration of response was 25.3 weeks, with no serious adverse events reported.
Conclusions:
- Injectable daxibotulinumtoxinA up to 450 U appears well-tolerated and effective for cervical dystonia treatment.
- Preliminary findings suggest prolonged efficacy, warranting further investigation in larger trials.
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