Randomized, Placebo-Controlled 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; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00257660

2005-000709-70 (EudraCT Number)

Y-47-52120-051

Details and patient eligibility

About

The aim of this study is to demonstrate the effectiveness and safety of 500 units of Dysport manufactured at a new manufacturing facility in Europe.

Enrollment: 116 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Cervical dystonia with at least 18 months since onset, and previously untreated with botulinum toxin or previously treated with botulinum toxin type A or B with a minimum interval of 16 weeks since the last injection and having returned at least to their usual pre-treatment status
• TWSTRS severity, disability and total scores meeting the defined criteria at baseline

Exclusion criteria

• Pure anterocollis or pure retrocollis
• In apparent remission from cervical dystonia
• Previous poor response to the last two botulinum toxin type A or type B treatments
• Being treated with type B toxin due to lack of efficacy to type A toxin or have known neutralizing antibodies to type A toxin

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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116 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Drug: abobotulinumtoxinA (Dysport®)

Treatment:

Biological: Botulinum toxin type A

2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo