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

Ipsen372 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

372

Conditions

Cervical Dystonia

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Unnamed facility

Graz, Austria

Unnamed facility

Wiesbaden, Germany

Outcomes

Primary Outcomes

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.

Time frame: Baseline and 12 weeks post-injection Cycle 2

Secondary Outcomes

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.

Time frame: Baseline and 12 weeks post-injection Cycle 1

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.

Time frame: Baseline and 12 weeks post-injection Cycle 3

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.

Time frame: Baseline and 12 weeks post-injection Cycle 4

Data from ClinicalTrials.gov

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