IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Cervical Dystonia

Main Inclusion Criteria:

• Male or female outpatients between ages 18 and 75 years inclusive)

• A clinical diagnosis of cervical dystonia (i.e. spasmodic torticollis) withpredominantly rotational form and a need for injection (determined by the TorontoWestern Spasmodic Torticollis Rating Scale (TWSTRS) -Total score)

• TWSTRS-Total score >= 20

• TWSTRS-Severity score >= 10

• TWSTRS-Disability score >= 3

• TWSTRS-Pain score >= 1

• On a stable dose of medications (if any) used for focal dystonia treatment (e.g.anticholinergics and benzodiazepines) for at least 3 months prior to and expectedthroughout the Main Period

• For pre-treated patients only: Source documentation of the last two consecutiveinjection sessions with Botulinum Toxin and stable therapeutic response directly priorto trial entry

• For pre-treated patients only: At least 10 weeks must have been passed between thelast injection with Botulinum Toxin for cervical dystonia and baseline

• For pre-treated patients only: The most recent injection with Botulinum Toxin musthave been maximal 300 Units of type A or 12,000 Units of type B

Main Exclusion Criteria:

• Traumatic torticollis or tardive torticollis

• TWSTRS-Severity score for anterocollis >= 2 points (pure anterocollis)

• TWSTRS-Severity score for retrocollis >= 2 points (pure retrocollis)

• Myotomy or denervation surgery in the affected muscles (e.g. peripheral denervationand/or spinal cord stimulation)

• Hypersensitivity to human serum albumin, sucrose, or Botulinum Toxin Type A

• Diagnosis of myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis,or any other significant neuromuscular disease which might interfere with the trial

• Current swallowing disorder of any origin (dysphagia scale >= 3, i.e. severe, withswallowing difficulties and requiring a change in diet)

• Marked limitation on passive range of motion that suggests contractures or otherstructural abnormality, e.g. cervical contractures or cervical spine syndrome

• Treatment with Botulinum Toxins for any indication other than cervical dystonia within 4 months prior to baseline and during the trial