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Randomized, Placebo-Controlled Study of AbobotulinumtoxinA (Dysport®) for the Treatment of Cervical Dystonia

Primary Purpose

Cervical Dystonia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Botulinum toxin type A
Placebo
Sponsored by
Ipsen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Dystonia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Cervical dystonia with at least 18 months since onset, and previously untreated with botulinum toxin or previously treated with botulinum toxin type A or B with a minimum interval of 16 weeks since the last injection and having returned at least to their usual pre-treatment status TWSTRS severity, disability and total scores meeting the defined criteria at baseline Exclusion Criteria: Pure anterocollis or pure retrocollis In apparent remission from cervical dystonia Previous poor response to the last two botulinum toxin type A or type B treatments Being treated with type B toxin due to lack of efficacy to type A toxin or have known neutralizing antibodies to type A toxin

Sites / Locations

  • St. Joseph's Hospital and Medical Center
  • Parkinson's and Movement Disorder Institute
  • USC School of Medicine
  • University of Florida
  • University of Miami
  • Emory University
  • Rush University Medical Center
  • University of Iowa
  • University of Maryland Medical Center
  • Wayne State University Medical Center
  • Albany Medical Center
  • Beth Israel Medical Center
  • Columbia University
  • Wake Forest University
  • Allegeheny General
  • University of Texas Southwest
  • Baylor College of Medicine
  • Swedish Neuroscience
  • Scientific Research Institute of Neurology, RAMS
  • Clinic "Cecil Plus"
  • Municipal Multi-Speciality Hospital #2
  • St Petersburg Pavlov State Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Drug: abobotulinumtoxinA (Dysport®)

Placebo

Outcomes

Primary Outcome Measures

Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for each is the following: for severity from 0 (absence of severity) to 35 (max severity), for disability from 0 (no disability) to 30 (max disability) and for pain from 0 (no pain) to 20 (max pain). TWSTRS total score is the sum of the 3 component scores, with a range from 0 to a maximum of 85. The change in TWSTRS total score is the score at week 4 minus the score at baseline.

Secondary Outcome Measures

Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for each is the following: for severity from 0 (absence of severity) to 35 (max severity), for disability from 0 (no disability) to 30 (max disability) and for pain from 0 (no pain) to 20 (max pain). TWSTRS total score is the sum of the 3 component scores, with a range from 0 to a maximum of 85. The change in TWSTRS total score is the score at week 4 minus the score at baseline.
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score
TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for each is the following: for severity from 0 (absence of severity) to 35 (max severity), for disability from 0 (no disability) to 30 (max disability) and for pain from 0 (no pain) to 20 (max pain). TWSTRS total score is the sum of the 3 component scores, with a range from 0 to a maximum of 85. The change in TWSTRS total score is the score at week 4 minus the score at baseline.
Subject Visual Analogue Score (VAS) for Cervical Dystonia (CD) Symptom Assessment
The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).
Investigator VAS for CD Symptom Assessment
The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).
Subject VAS for CD Symptom Assessment
The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100mm (worst possible symptoms).
Investigator's VAS for CD Symptom Assessment
The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).
Subject VAS for CD Symptom Assessment
The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).
Investigator's VAS for CD Symptom Assessment
The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms) to 100 mm (worst possible symptoms).
SF-36 Mental Health Summary Score
SF-36 is a Quality of Life scale comprising eight individual domains. The QoL score for each domain is on a scale from 0 (worst health possible) to 100 (best health possible). SF-36 Mental Health Summary Score is derived from four individual domains (vitality, social functioning, role limitations due to emotional problems and mental health).
SF-36 Physical Health Summary Score
SF-36 is a Quality of Life scale comprising eight individual domains. The QoL score for each domain is on a scale from 0 (worst health possible) to 100 (best health possible). SF-36 Physical Health Summary Score is derived from four individual domains (physical functioning, role physical, bodily pain and general health).
Number of Participants Considered by the Investigator to be Overall Treatment Successes
The number of participants considered to be overall treatment successes by the investigator at week 12 was assessed.

Full Information

First Posted
November 22, 2005
Last Updated
September 15, 2022
Sponsor
Ipsen
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1. Study Identification

Unique Protocol Identification Number
NCT00257660
Brief Title
Randomized, Placebo-Controlled Study of AbobotulinumtoxinA (Dysport®) for the Treatment of Cervical Dystonia
Official Title
A Phase III Multicentre, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Dysport® for the Treatment of Cervical Dystonia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
October 10, 2005 (Actual)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
September 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ipsen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to demonstrate the effectiveness and safety of 500 units of Dysport manufactured at a new manufacturing facility in Europe.

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
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Drug: abobotulinumtoxinA (Dysport®)
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Biological
Intervention Name(s)
Botulinum toxin type A
Other Intervention Name(s)
AbobotulinumtoxinA (Dysport®)
Intervention Description
500 units
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
500 units
Primary Outcome Measure Information:
Title
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
Description
TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for each is the following: for severity from 0 (absence of severity) to 35 (max severity), for disability from 0 (no disability) to 30 (max disability) and for pain from 0 (no pain) to 20 (max pain). TWSTRS total score is the sum of the 3 component scores, with a range from 0 to a maximum of 85. The change in TWSTRS total score is the score at week 4 minus the score at baseline.
Time Frame
Baseline and Week 4
Secondary Outcome Measure Information:
Title
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
Description
TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for each is the following: for severity from 0 (absence of severity) to 35 (max severity), for disability from 0 (no disability) to 30 (max disability) and for pain from 0 (no pain) to 20 (max pain). TWSTRS total score is the sum of the 3 component scores, with a range from 0 to a maximum of 85. The change in TWSTRS total score is the score at week 4 minus the score at baseline.
Time Frame
Baseline and Week 8
Title
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score
Description
TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for each is the following: for severity from 0 (absence of severity) to 35 (max severity), for disability from 0 (no disability) to 30 (max disability) and for pain from 0 (no pain) to 20 (max pain). TWSTRS total score is the sum of the 3 component scores, with a range from 0 to a maximum of 85. The change in TWSTRS total score is the score at week 4 minus the score at baseline.
Time Frame
Baseline and Week 12
Title
Subject Visual Analogue Score (VAS) for Cervical Dystonia (CD) Symptom Assessment
Description
The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).
Time Frame
Baseline and Week 4
Title
Investigator VAS for CD Symptom Assessment
Description
The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).
Time Frame
Baseline and Week 4
Title
Subject VAS for CD Symptom Assessment
Description
The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100mm (worst possible symptoms).
Time Frame
Baseline and Week 8
Title
Investigator's VAS for CD Symptom Assessment
Description
The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).
Time Frame
Baseline and week 8
Title
Subject VAS for CD Symptom Assessment
Description
The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).
Time Frame
Baseline and week 12
Title
Investigator's VAS for CD Symptom Assessment
Description
The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms) to 100 mm (worst possible symptoms).
Time Frame
Baseline and week 12
Title
SF-36 Mental Health Summary Score
Description
SF-36 is a Quality of Life scale comprising eight individual domains. The QoL score for each domain is on a scale from 0 (worst health possible) to 100 (best health possible). SF-36 Mental Health Summary Score is derived from four individual domains (vitality, social functioning, role limitations due to emotional problems and mental health).
Time Frame
Week 8
Title
SF-36 Physical Health Summary Score
Description
SF-36 is a Quality of Life scale comprising eight individual domains. The QoL score for each domain is on a scale from 0 (worst health possible) to 100 (best health possible). SF-36 Physical Health Summary Score is derived from four individual domains (physical functioning, role physical, bodily pain and general health).
Time Frame
Week 8
Title
Number of Participants Considered by the Investigator to be Overall Treatment Successes
Description
The number of participants considered to be overall treatment successes by the investigator at week 12 was assessed.
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Cervical dystonia with at least 18 months since onset, and previously untreated with botulinum toxin or previously treated with botulinum toxin type A or B with a minimum interval of 16 weeks since the last injection and having returned at least to their usual pre-treatment status TWSTRS severity, disability and total scores meeting the defined criteria at baseline Exclusion Criteria: Pure anterocollis or pure retrocollis In apparent remission from cervical dystonia Previous poor response to the last two botulinum toxin type A or type B treatments Being treated with type B toxin due to lack of efficacy to type A toxin or have known neutralizing antibodies to type A toxin
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ipsen Medical Director
Organizational Affiliation
Ipsen
Official's Role
Study Director
Facility Information:
Facility Name
St. Joseph's Hospital and Medical Center
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
Parkinson's and Movement Disorder Institute
City
Fountain Valley
State/Province
California
Country
United States
Facility Name
USC School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
Country
United States
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Wayne State University Medical Center
City
Southfield
State/Province
Michigan
Country
United States
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
Country
United States
Facility Name
Beth Israel Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Columbia University
City
New York
State/Province
New York
Country
United States
Facility Name
Wake Forest University
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
Allegeheny General
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
University of Texas Southwest
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
Country
United States
Facility Name
Swedish Neuroscience
City
Seattle
State/Province
Washington
Country
United States
Facility Name
Scientific Research Institute of Neurology, RAMS
City
Moscow
ZIP/Postal Code
123367
Country
Russian Federation
Facility Name
Clinic "Cecil Plus"
City
Moscow
ZIP/Postal Code
125047
Country
Russian Federation
Facility Name
Municipal Multi-Speciality Hospital #2
City
St Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
St Petersburg Pavlov State Medical University
City
St Petersburg
ZIP/Postal Code
197022
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of study participants. Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.
IPD Sharing Time Frame
Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
IPD Sharing Access Criteria
Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).
IPD Sharing URL
https://vivli.org/members/ourmembers/
Citations:
PubMed Identifier
20359934
Citation
Truong D, Brodsky M, Lew M, Brashear A, Jankovic J, Molho E, Orlova O, Timerbaeva S; Global Dysport Cervical Dystonia Study Group. Long-term efficacy and safety of botulinum toxin type A (Dysport) in cervical dystonia. Parkinsonism Relat Disord. 2010 Jun;16(5):316-23. doi: 10.1016/j.parkreldis.2010.03.002. Epub 2010 Mar 31.
Results Reference
result
PubMed Identifier
25324317
Citation
Mordin M, Masaquel C, Abbott C, Copley-Merriman C. Factors affecting the health-related quality of life of patients with cervical dystonia and impact of treatment with abobotulinumtoxinA (Dysport): results from a randomised, double-blind, placebo-controlled study. BMJ Open. 2014 Oct 16;4(10):e005150. doi: 10.1136/bmjopen-2014-005150.
Results Reference
derived

Learn more about this trial

Randomized, Placebo-Controlled Study of AbobotulinumtoxinA (Dysport®) for the Treatment of Cervical Dystonia

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