Comparison of Efficacy and Safety of Two Different Types of Botulinum Toxin Type A in Moderate to Severe Cervical Dystonia

Allergan

Status and phase: Completed; Phase 4

Conditions: Spasmodic Torticollis

Treatments: Biological: botulinum toxin type A

Study type: Interventional

Funder types: Industry

Identifiers

NCT00528541

MedAff-BTX-0616

Details and patient eligibility

About

The purpose of this study is to compare two types of botulinum toxin type A to treat the involuntary muscle contractions in the neck

Enrollment: 145 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with cervical dystonia/spasmodic torticollis for at least 18 months
• Successfully treated previously with botulinum toxin type A

Exclusion criteria

• Breast feeding, pregnant or could become pregnant
• Surgery or spinal cord stimulation for cervical dystonia
• Previous injections of phenol, alcohol for cervical dystonia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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145 participants in 2 patient groups

BOTOX®

Active Comparator group

Description:

botulinum toxin type A (BOTOX®)

Treatment:

Biological: botulinum toxin type A

Biological: botulinum toxin type A

Dysport®

Active Comparator group

Description:

botulinum toxin type A (Dysport®)

Treatment:

Biological: botulinum toxin type A

Biological: botulinum toxin type A