At a glance
ClinicalIndex Comparison Record- ✓Prior enrollment in study Y-47-52120-051 with completion of all visits through Week 12 (or Week 4 if early withdrawal)
- ✓Returned to pre-treatment baseline status as judged by the Investigator
- ✕Pure anterocollis or pure retrocollis
- ✕Known antibodies to botulinum toxin type A
- ✕Requirement for botulinum toxin injections outside the neck and unable to avoid such treatment during the study
- ✕Known significant underlying swallowing or respiratory abnormality that may be worsened by botulinum toxin treatment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Botulinum toxin type A for Cervical Dystonia. Completed, enrolled 108 participants across 18 sites in 2 countries.
Detailed Summary
The aim of this study is to assess longer term safety and effectiveness of Dysport®.
Study Details
Timeline
Interventions
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.