NCT00288509

Open-label Extension Study of AbobotulinumtoxinA (Dysport®) for the Treatment of Cervical Dystonia

A Phase III, Prospective, Multicenter, Open-label Extension Study to Assess the Longer Term Safety and Efficacy of Repeated Treatment of Dysport® Intramuscular Injection in the Treatment of Cervical Dystonia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Ipsen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to assess longer term safety and effectiveness of Dysport®.

Conditions

• Cervical Dystonia

Interventions

Type	Name	Description
BIOLOGICAL	Botulinum toxin type A	In this long-term extension study, a dose of 500 units Dysport was administered by intramuscular injection into the clinically indicated neck muscles in a single dosing session in the first treatment cycle. This was the same dose as given in the preceding study NCT00257660 (Y-47-52120-051). Based on individual safety \& efficacy, subjects could then receive up to 3 subsequent injections with doses titrated in 250 unit steps, to a minimum of 250 units and a maximum of 1000 units. Retreatment occurred approximately 12-16 weeks after the previous injection, with the exact timing based on clinical need.

Timeline

• Start date: 2006-02-01
• Primary completion: 2008-01-01
• Completion: 2008-01-01
• First posted: 2006-02-08
• Last updated: 2022-09-28
• Results posted: 2010-04-02

Locations

18 sites across 2 countries: United States, Russia