NCT00447772

Study to Assess the Efficacy and Safety of Dysport® in Cervical Dystonia

Multicentre Open Study on the Efficacy and Safety of Botulinum Toxin A (500 Units Dysport®) in the Treatment of Heterogeneous Forms of Cervical Dystonia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 516 (actual)
• Sponsor: Ipsen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim is to demonstrate equivalent efficacy and safety in the treatment of the two most frequent forms of cervical dystonia (predominantly rotational torticollis and predominantly laterocollis) with the standard initial dose of 500 units Dysport®. The patients will be assigned to one of the two basic types of cervical dystonia, either predominantly rotational torticollis or predominantly laterocollis on the basis of clinical examination. This will determine which therapy is to be administered, using the clearly defined, structured injection protocols.

Conditions

• Cervical Dystonia

Interventions

Type	Name	Description
BIOLOGICAL	Botulinum toxin type A	Active Drug: Botulinum type A toxin (Dysport®) 500 Units / 2.5 ml injected in muscles involved in cervical dystonia

Timeline

• Start date: 2004-10-01
• Primary completion: 2008-02-01
• Completion: 2008-04-01
• First posted: 2007-03-15
• Last updated: 2023-03-30
• Results posted: 2018-07-30

Locations

106 sites across 2 countries: Austria, Germany