Status:
COMPLETED
IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Cervical Dystonia
Lead Sponsor:
Merz Pharmaceuticals GmbH
Conditions:
Cervical Dystonia
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- Main
- 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
- 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
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
233 Patients enrolled
Trial Details
Trial ID
NCT00407030
Start Date
July 1 2006
End Date
June 1 2009
Last Update
July 19 2013
Active Locations (1)
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1
Dallas, Texas, United States