NCT03617367

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

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 357 (actual)
• Sponsor: Revance Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Cervical Dystonia

Interventions

Type	Name	Description
BIOLOGICAL	daxibotulinumtoxinA for injection	DaxibotulinumtoxinA for injection is a sterile, white to off-white lyophilized product containing the active ingredient, daxibotulinumtoxinA, and inactive ingredients to be reconstituted with sterile, non-preserved, 0.9% sodium chloride solution saline.

Timeline

• Start date: 2018-09-05
• Primary completion: 2021-05-25
• Completion: 2021-05-25
• First posted: 2018-08-06
• Last updated: 2022-01-28

Locations

65 sites across 9 countries: United States, Austria, Canada, Czechia, France, Germany, Poland, Spain, United Kingdom

Regulatory

• FDA-regulated drug study