drugset / Trial / NCT03617367

Long-Term Safety and Efficacy of Repeat Treatments of DaxibotulinumtoxinA for Injection in Adults With Isolated Cervical Dystonia (ASPEN-OLS)

NCT03617367 ↗

Phase 3 Completed 357 enrolled Revance Therapeutics, Inc. Syneos Health · collab
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

EvaluationDrugModalityDoseRoute
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 —

Indications