NCT00541905

Daily Dystonia Practice - A Trial to Investigate NT 201, the Duration of Treatment Effect After One Injection Session and in Long-term Treatment in Cervical Dystonia

Prospective, Single-arm, Multicenter Trial to Investigate the Efficacy and Safety of NT 201 and the Duration of Treatment Effect After One Injection Session and in Long-term Treatment in Patients With Cervical Dystonia

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Merz Pharmaceuticals GmbH · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to confirm efficacy and safety of NT 201 (Xeomin®, also known as IncobotulinumtoxinA) after one injection session and to determine the efficacy and safety profile and the duration of treatment effect of NT 201 in long-term treatment with repeated injection sessions.

Conditions

• Cervical Dystonia

Interventions

Type	Name	Description
DRUG	NT 201	Subjects to receive up to 5 injection sessions, with a total dose of up to 300 Units each. No more than 50 units should have be given at any one injection site during one session.

Timeline

• Start date: 2007-09-01
• Primary completion: 2008-10-01
• Completion: 2010-05-01
• First posted: 2007-10-10
• Last updated: 2013-06-04

Locations

1 site across 1 country: Germany