Back to resultsIncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Cervical Dystonia
Primary Purpose
Cervical Dystonia
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
incobotulinumtoxinA (Xeomin) (240 Units)
incobotulinumtoxinA (Xeomin) (120 Units)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Dystonia
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
incobotulinumtoxinA (Xeomin) (240 Units)
incobotulinumtoxinA (Xeomin) (120 Units)
Placebo
Arm Description
incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 240 units, total volume 4.8mL; Mode of administration: intramuscular injection
incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 120 units, total volume 4.8 mL; Mode of administration: intramuscular injection
Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 4.8 mL; Mode of administration: intramuscular injection
Outcomes
Primary Outcome Measures
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
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.
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
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.
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)
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 Outcome Measures
Change From Baseline in the TWSTRS-Total Score
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.
Change From Baseline in the TWSTRS Disability Subscore
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.
Change From Baseline in the TWSTRS Severity Subscore
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.
Change From Baseline in the TWSTRS Pain Subscore
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.
Patient Evaluation of Global Response (PEGR) at Final Visit
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).
Full Information
NCT ID
NCT00407030
First Posted
November 30, 2006
Last Updated
July 12, 2013
Sponsor
Merz Pharmaceuticals GmbH
1. Study Identification
Unique Protocol Identification Number
NCT00407030
Brief Title
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
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merz Pharmaceuticals GmbH
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Dystonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
233 (Actual)
8. Arms, Groups, and Interventions
Arm Title
incobotulinumtoxinA (Xeomin) (240 Units)
Arm Type
Experimental
Arm Description
incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 240 units, total volume 4.8mL; Mode of administration: intramuscular injection
Arm Title
incobotulinumtoxinA (Xeomin) (120 Units)
Arm Type
Experimental
Arm Description
incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 120 units, total volume 4.8 mL; Mode of administration: intramuscular injection
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 4.8 mL; Mode of administration: intramuscular injection
Intervention Type
Drug
Intervention Name(s)
incobotulinumtoxinA (Xeomin) (240 Units)
Intervention Description
incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (240 Units)
Intervention Type
Drug
Intervention Name(s)
incobotulinumtoxinA (Xeomin) (120 Units)
Intervention Description
incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (120 Units)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Baseline, week 4
Title
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
Description
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.
Time Frame
Baseline, week 4
Title
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)
Description
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.
Time Frame
Baseline, week 4
Secondary Outcome Measure Information:
Title
Change From Baseline in the TWSTRS-Total Score
Description
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.
Time Frame
Baseline, week 8, final visit (up to 20 weeks after injection of the Main Period)
Title
Change From Baseline in the TWSTRS Disability Subscore
Description
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.
Time Frame
Baseline, week 4, week 8, final visit (up to 20 weeks after injection of the Main Period)
Title
Change From Baseline in the TWSTRS Severity Subscore
Description
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.
Time Frame
Baseline, week 4, week 8, final visit (up to 20 weeks after injection of the Main Period)
Title
Change From Baseline in the TWSTRS Pain Subscore
Description
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.
Time Frame
Baseline, week 4, week 8, final visit (up to 20 weeks after injection of the Main Period)
Title
Patient Evaluation of Global Response (PEGR) at Final Visit
Description
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).
Time Frame
Final visit (up to 20 weeks after injection of the Main Period)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia Comella, M.D.
Organizational Affiliation
Rush University Medical Center, 1725 West Harrison Street, Suite 755, Chicago, 60612 Illinois, USA
Official's Role
Study Chair
Facility Information:
City
Dallas
State/Province
Texas
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21764407
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.
Results Reference
result
PubMed Identifier
23779062
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.
Results Reference
result
Learn more about this trial
IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Cervical Dystonia
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