IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Cervical Dystonia
Condition: Cervical Dystonia
MeSH terms: Dystonia; Dystonic Disorders; Torticollis
Intervention: incobotulinumtoxinA (Xeomin) (240 Units); incobotulinumtoxinA (Xeomin) (120 Units); Placebo
Intervention description: incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (240 Units); incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (120 Units); Placebo
Intervention MeSH terms: incobotulinumtoxinA; Botulinum Toxins, Type A
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 233.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      At baseline patients received incobotulinumtoxinA (Xeomin) or placebo. Thereafter, all
      patients who entered the extension period were treated with up to five injection sessions of
      incobotulinumtoxinA (Xeomin) during the extension period.
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  Male or female outpatients between ages 18 and 75 years inclusive)

          -  A clinical diagnosis of cervical dystonia (i.e. spasmodic torticollis) with
             predominantly rotational form and a need for injection (determined by the Toronto
             Western 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 expected
             throughout the Main Period

          -  For pre-treated patients only: Source documentation of the last two consecutive
             injection sessions with Botulinum Toxin and stable therapeutic response directly prior
             to trial entry

          -  For pre-treated patients only: At least 10 weeks must have been passed between the
             last injection with Botulinum Toxin for cervical dystonia and baseline

          -  For pre-treated patients only: The most recent injection with Botulinum Toxin must
             have 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 denervation
             and/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, with
             swallowing difficulties and requiring a change in diet)

          -  Marked limitation on passive range of motion that suggests contractures or other
             structural 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