Study to Assess the Efficacy and Safety of Dysport® in 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

NCT00447772

2004-002086-20 (EudraCT Number)

A-94-52120-098

Details and patient eligibility

About

The aim is to demonstrate equivalent efficacy and safety in the treatment of the two most frequent forms of cervical dystonia (predominantly rotational torticollis and predominantly laterocollis) with the standard initial dose of 500 units Dysport®. The patients will be assigned to one of the two basic types of cervical dystonia, either predominantly rotational torticollis or predominantly laterocollis on the basis of clinical examination. This will determine which therapy is to be administered, using the clearly defined, structured injection protocols.

Enrollment: 516 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• De novo patients with cervical dystonia
• Outpatient
• Patients to be of age 18 years or older
• Written informed consent to participate in the study

Exclusion criteria

• Pre-treatment of cervical dystonia with botulinum toxin
• Pre-treatment with botulinum toxin for any indication other than cervical dystonia within the past 12 months
• Pure retro- or antecollis
• Neurological or other diseases which may affect head and neck motor function or neuromuscular transmission, e.g. polyneuropathy with pareses, myasthenia, myopathy, motor neurone diseases, Bekhterev's disease

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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516 participants in 1 patient group

1

Experimental group

Treatment:

Biological: Botulinum toxin type A