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Completed

NCT Number: NCT00407030

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

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.

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Key information

Conditions

Cervical Dystonia Dyskinesias Dystonia Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Torticollis

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Dallas, Texas, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

incobotulinumtoxinA (Xeomin) (240 Units)

Drug

incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (240 Units)

incobotulinumtoxinA (Xeomin) (120 Units)

Drug

incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (120 Units)

Placebo

Drug

Placebo

Primary outcomes

  1. 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

    Time frame: Baseline, week 4

    The TWSTRS-Total score is the sum of scores of the three components of the scale:

    • TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity)
    • TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain)
    • TWSTRS-Disability score which ranges from 0 (=no disability) to 30 (=maximum disability).

    The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.

  2. 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

    Time frame: Baseline, week 4

    The TWSTRS-Total score is the sum of scores of the three components of the scale:

    • TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity)
    • TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain)
    • TWSTRS-Disability score which ranges from 0 (=no disability) to 30 (=maximum disability).

    The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.

  3. 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)

    Time frame: Baseline, week 4

    The TWSTRS-Total score is the sum of scores of the three components of the scale:

    • TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity)
    • TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain)
    • TWSTRS-Disability score which ranges from 0 (=no disability) to 30 (=maximum disability).

    The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.

Secondary outcomes

  1. Change From Baseline in the TWSTRS-Total Score

    Time frame: Baseline, week 8, final visit (up to 20 weeks after injection of the Main Period)

    The TWSTRS-Total score is the sum of scores of the three components of the scale:

    • TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity)
    • TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain)
    • TWSTRS-Disability score which ranges from 0 (=no disability) to 30 (=maximum disability).

    The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.

  2. Change From Baseline in the TWSTRS Disability Subscore

    Time frame: Baseline, week 4, week 8, final visit (up to 20 weeks after injection of the Main Period)

    TWSTRS-Disability score which ranges from 0 (=no disability)to 30 (=maximum disability). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.

  3. Change From Baseline in the TWSTRS Severity Subscore

    Time frame: Baseline, week 4, week 8, final visit (up to 20 weeks after injection of the Main Period)

    TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.

  4. Change From Baseline in the TWSTRS Pain Subscore

    Time frame: Baseline, week 4, week 8, final visit (up to 20 weeks after injection of the Main Period)

    TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.

  5. Patient Evaluation of Global Response (PEGR) at Final Visit

    Time frame: Final visit (up to 20 weeks after injection of the Main Period)

    The PEGR is a descriptive subjective 9-point response scale ranging from "complete abolishment of signs and symptoms" (value=+4) down to "very marked worsening" (value=-4).

Sponsors and collaborators

Lead sponsor

Merz Pharmaceuticals GmbH

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2008
Study completion
2009
First posted
Dec 4, 2006
Registry last updated
Jul 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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