Longitudinal Study for Treatment With Botulinum Toxin A Injections in naïve and Pre-treated Patients Suffering From Cervical Dystonia [CD-NIS-Longterm]

Cervical Dystonia Clinical Trial

— CDNISLongterm  

Official title:

A National, Multicenter, Non-interventional, Prospective, Longitudinal Study for Treatment With Botulinum Toxin A Injections in naïve and Pre-treated Patients Suffering From Cervical Dystonia (Dysport®)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01840462
• Other study ID #: A-94-52120-165
• Status: Completed
• Start date: July 2012
• Est. completion date: March 2016

Study information

• Verified date: January 2019
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objective of this study is to investigate the efficacy of Dysport® in the treatment of cervical dystonia (CD) in a non-interventional long-term study in naïve and pre-treated patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 372
• Est. completion date: March 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Suffering from cervical dystonia with rotational torticollis/-caput or laterocollis/-caput as the primary component

• Naïve to botulinum toxin A or pre-treated with botulinum toxin A on a regular basis for at least 2 years prior to inclusion and last injection with Dysport® and last injection between 3 and 6 months prior to inclusion

• With the intention to be treated with Dysport®

Exclusion Criteria:

• The subject has already been included in this study

• Participation in an interventional trial

• Suffering from anterocollis or retrocollis as primary component

Related Conditions & MeSH terms

• Cervical Dystonia
• Dystonia
• Dystonic Disorders
• Torticollis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Tsui scores	The Tsui rating scale is a disease-specific score to evaluate the severity of CD taking the clinical signs of CD into account in a standardised manner.	Baseline and 12 weeks post-injection Cycle 2
Secondary	Change in Tsui scores	The Tsui rating scale is a disease-specific score to evaluate the severity of CD taking the clinical signs of CD into account in a standardised manner.	Baseline and 12 weeks post-injection Cycle 1
Secondary	Change in Tsui scores	The Tsui rating scale is a disease-specific score to evaluate the severity of CD taking the clinical signs of CD into account in a standardised manner.	Baseline and 12 weeks post-injection Cycle 3
Secondary	Change in Tsui scores	The Tsui rating scale is a disease-specific score to evaluate the severity of CD taking the clinical signs of CD into account in a standardised manner.	Baseline and 12 weeks post-injection Cycle 4