drugset / Trial / NCT03617367
Long-Term Safety and Efficacy of Repeat Treatments of DaxibotulinumtoxinA for Injection in Adults With Isolated Cervical Dystonia (ASPEN-OLS)
NaSingle-groupOpen-labelTreatment
Summary
Phase 3, open-label, multi-center trial to evaluate the long-term safety, efficacy, and immunogenicity of up to four continuous treatment cycles of daxibotulinumtoxinA (DAXI) for injection.
Timeline
- Start
- 2018-09-05
- Primary completion
- 2021-05-25
- Completion
- 2021-05-25
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Botulinum toxin type A | Protein / enzyme biologic | 50 iu | — |
| Subject | Botulinum toxin type A | Protein / enzyme biologic | 75 iu | — |
| Subject | Botulinum toxin type A | Protein / enzyme biologic | 125 iu | — |
| Subject | Botulinum toxin type A | Protein / enzyme biologic | 250 iu | — |
| Subject | Botulinum toxin type A | Protein / enzyme biologic | 300 iu | — |