Clinical trial NCT00407030: IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Cervical Dystonia
Official title: Prospective, Double-blind, Placebo-controlled, Randomized, Multi-center Trial With a Double-blind Parallel-group Extension Period to Investigate the Efficacy and Safety of Different Doses of IncobotulinumtoxinA (Xeomin) in the Treatment of Cervical Dystonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cervical Dystonia
Lead sponsor: Merz Pharmaceuticals GmbH
Sponsor class: INDUSTRY
First posted: 2006-12-04
Enrollment: 233
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 (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

Primary outcomes:
measure: Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Injection of the Main Period - Xeomin (240 Units) Versus Placebo
timeFrame: Baseline, week 4
measure: Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Injection of the Main Period - Xeomin (120 Units) Versus Placebo
timeFrame: Baseline, week 4
measure: Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Injection of the Main Period - Xeomin (240 Units) Versus Xeomin (120 Units)
timeFrame: Baseline, week 4
Secondary outcomes:
measure: Change From Baseline in the TWSTRS-Total Score
timeFrame: Baseline, week 8, final visit (up to 20 weeks after injection of the Main Period)
measure: Change From Baseline in the TWSTRS Disability Subscore
timeFrame: Baseline, week 4, week 8, final visit (up to 20 weeks after injection of the Main Period)
measure: Change From Baseline in the TWSTRS Severity Subscore
timeFrame: Baseline, week 4, week 8, final visit (up to 20 weeks after injection of the Main Period)
measure: Change From Baseline in the TWSTRS Pain Subscore
timeFrame: Baseline, week 4, week 8, final visit (up to 20 weeks after injection of the Main Period)
measure: Patient Evaluation of Global Response (PEGR) at Final Visit
timeFrame: Final visit (up to 20 weeks after injection of the Main Period)
Other outcomes:
Locations:
city: Dallas
country: United States
state: Texas
Study officials:
affiliation: Rush University Medical Center, 1725 West Harrison Street, Suite 755, Chicago, 60612 Illinois, USA
name: Cynthia Comella, M.D.
role: STUDY_CHAIR
References:
citation: Comella CL, Jankovic J, Truong DD, Hanschmann A, Grafe S; U.S. XEOMIN Cervical Dystonia Study Group. Efficacy and safety of incobotulinumtoxinA (NT 201, XEOMIN(R), botulinum neurotoxin type A, without accessory proteins) in patients with cervical dystonia. J Neurol Sci. 2011 Sep 15;308(1-2):103-9. doi: 10.1016/j.jns.2011.05.041. Epub 2011 Jul 18.
citation: Evidente VG, Fernandez HH, LeDoux MS, Brashear A, Grafe S, Hanschmann A, Comella CL. A randomized, double-blind study of repeated incobotulinumtoxinA (Xeomin((R))) in cervical dystonia. J Neural Transm (Vienna). 2013 Dec;120(12):1699-707. doi: 10.1007/s00702-013-1048-3. Epub 2013 Jun 19.