drugset / Trial / NCT01261611

Study Comparing Short Term Efficacy of Dysport and Dysport NG to Placebo, and to Assess Efficacy and Safety of Dysport NG of Subjects With Cervical Dystonia

NCT01261611

Phase 3 Completed 382 enrolled Ipsen
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate how well a new drug called Dysport NG works and how safe it is, when it is used for the treatment of cervical dystonia. Dysport NG will be compared to an approved drug called Dysport.

Timeline

Start
2011-04
Primary completion
2012-05
Completion
2013-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Botulinum toxin type A Protein / enzyme biologic 250 iu Intramuscular
Comparator Botulinum toxin type A Protein / enzyme biologic 500 iu Intramuscular
Comparator Botulinum toxin type A Protein / enzyme biologic 750 iu Intramuscular
Comparator Botulinum toxin type A Protein / enzyme biologic 1000 iu Intramuscular

Indications