Long Term Safety And Effectiveness Of Dysport In Adults With Cervical Dystonia

• Status: Completed
• Trial end date: 0000-00-00
• Target enrollment: 112
• Participant gender: Both

Summary

The purpose of the protocol is to assess the long term safety of repeat treatment cycles of Dysport 500 U using 2 mL dilution scheme for the treatment of Cervical Dystonia. This is an extension study to study A-TL-52120-169 (hereafter referred to as Study 169).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ipsen
• Treatments: abobotulinumtoxinA; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA
• Last Updated: 2015-12-21

Criteria

Inclusion Criteria:

• Subjects enrolled in Study 169 that have no ongoing adverse events, which in the opinion of the Investigator are related to study treatment and that precludes them from receiving continuing therapy

• Completed Study 169, or completed all study visits up to and including Week 4 and in the event of an early withdrawal after Week 4 have ≤15% reduction in TWSTRS total score at Week 4 compared to their baseline TWSTRS total score in the double-blind study, and in the Investigator's clinical judgment, would benefit from Dysport for CD.

Exclusion Criteria:

• Diagnosis of pure retrocollis or pure anterocollis

• Requirement for botulinum toxin injection to site(s) for disorders other than CD and unable to avoid such treatment(s) for the duration of the study

• Known hypersensitivity to botulinum toxin or related compounds, or any component in the study drug formulation

• Allergy to cow's milk protein