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

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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)

108 participants in 1 patient group

Dysport
Experimental group
Description:
250-1000 units
Treatment:
Biological: Botulinum toxin type A

Trial contacts and locations

18

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Data sourced from clinicaltrials.gov

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