Open-label Extension Study of AbobotulinumtoxinA (Dysport®) for the Treatment of Cervical Dystonia

Ipsen

Status and phase: Completed; Phase 3

Conditions: Cervical Dystonia

Treatments: Biological: Botulinum toxin type A

Study type: Interventional

Funder types: Industry

Identifiers

NCT00288509

Y-47-52120-731

2005-002429-29 (EudraCT Number)

Details and patient eligibility

About

The aim of this study is to assess longer term safety and effectiveness of Dysport®.

Enrollment: 108 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects enrolled in the Y-47-52120-051 study, who have completed all study visits up to Week 12, or up to Week 4 in the event of an early withdrawal
• Returned to pre-treatment status as judged by the Investigator

Exclusion criteria

• Pure anterocollis or pure retrocollis
• Known antibodies to botulinum toxin type A
• Requirement for botulinum toxin injections to site(s) other than the neck and unable to avoid such treatment for the duration of the study
• Known significant underlying swallowing or respiratory abnormality which might be exacerbated by botulinum toxin treatment

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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108 participants in 1 patient group

Dysport

Experimental group

Description:

250-1000 units

Treatment:

Biological: Botulinum toxin type A