DYSPORT™ Clinical & Health Economics Outcomes Registry in Cervical Dystonia (ANCHOR-CD)

Ipsen

Status: Completed

Conditions: Cervical Dystonia

Study type: Observational

Funder types: Industry

Identifiers

NCT01314365

A-TL-52120-156

Details and patient eligibility

About

The purpose of the protocol is to determine typical patient response to Dysport in the treatment of adult cervical dystonia (CD).

Enrollment: 350 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• A diagnosis of idiopathic CD as determined by the enrolling investigator
• If previously treated with a neurotoxin for CD, at least a 12-week interval must have elapsed between the last injection of Botulinum toxin A (BoNT-A) or Botulinum toxin B (BoNT-B) and the first dose of Dysport injected in this study
• Patient is able to comply with the protocol (e.g., can visit the clinic as required and can complete questionnaires/telephone interviews)
• Provision of written informed consent prior to enrollment

Exclusion criteria

• Contraindications to treatment with any BoNT-A or BoNT-B preparations
• Based on Investigator opinion, patients in whom previous BoNT-A or BoNT-B therapy has failed to produce a clinical response or produced an intolerable adverse reaction
• Anticipated concomitant treatment with BoNT for other than cervical dystonia
• Secondary cervical dystonia