A Study to Compare Dysport® and Botox® in the Treatment of Cervical Dystonia

Cervical Dystonia Clinical Trial

Official title: A Double Blind, Randomized, Multi-center, Cross-over Study to Demonstrate the Non-inferiority of Dysport® (abobotulinumtoxinA) in the Clinical Efficacy and Safety in Comparison With Botox®(onabotulinumtoxinA), Assuming a Bioequivalence Ratio of 2.5:1 Units, in the Treatment of Cervical Dystonia

Status Completed

Clinical Trial Summary

1. to examine the non-inferiority of Dysport in the clinical efficacy and safety in comparison with Botox®, assuming a bioequivalence ratio of 2.5:1 units, in the treatment of Cervical dystonia.

2. double blind, randomised, multi center, crossover study

Clinical Trial Description

1. Prospective, randomized, head-to-head, double-blind, cross-over study.

2. Total patients: A group 51, B group 51

3. Study duration: 16 + 4 + 16 weeks. Eligible patients will be randomised at baseline to receive either Dysport® or Botox® and monitored at weeks 2, 4, 8, 12, 16 weeks. After 4 weeks of wash out period, then the patients get the other treatment (i.e, Patients who have got Dysport will be then administered with Botox)

4. Compare the TSUI change score from baseline to 4 weeks after injection. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Dystonia
• Dystonia
• Dystonic Disorders
• Torticollis

• NCT number: NCT00950664
• Study type: Interventional
• Source: Seoul National University Hospital
• Status: Completed
• Phase: Phase 4
• Start date: August 2009
• Completion date: July 2011