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

Ipsen

Status: Completed

Conditions: Cervical Dystonia

Study type: Observational

Funder types: Industry

Identifiers

NCT01840462

A-94-52120-165

Details and patient eligibility

About

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.

Enrollment: 372 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

372 participants in 2 patient groups

Subjects naïve to botulinum toxin A (BoNT-A) treatment

Description:

Patients naïve to botulinum toxin A treatment

Subjects pre-treated with botulinum toxin A (BoNT-A) injection

Description:

Patients pre-treated with botulinum toxin A for at least 2 years. 4 injection cycles, each at 3 to 4 months intervals. Investigators follow their individual injection protocol for the treatment with BoNT-A (modalities of administration in accordance with local Summary of Product Characteristics).