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

Cervical Dystonia Clinical Trial

Official title:
A Phase 3, Open-Label, Multi-Center Trial to Evaluate the Long-Term Safety and Efficacy of Repeat Treatments of DaxibotulinumtoxinA for Injection in Adults With Isolated Cervical Dystonia (ASPEN-OLS)

Clinical Trial 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.

Clinical Trial Description

Approximately 350 adult subjects will be recruited from approximately 80 study centers in the United States, Canada, and Europe who were enrolled in the ASPEN-1 Study Protocol 1720302 and de novo subjects (not previously enrolled in ASPEN-1 Study Protocol 1720302) will be treated with up to 4 different doses of daxibotulinumtoxinA for injection. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03617367
Study type Interventional
Source Revance Therapeutics, Inc.
Contact
Status Completed
Phase Phase 3
Start date September 5, 2018
Completion date May 25, 2021
View Details
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