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

This study has been completed.
Sponsor:
Information provided by:
Ipsen
ClinicalTrials.gov Identifier:
NCT00257660
First received: November 22, 2005
Last updated: June 17, 2010
Last verified: June 2010

November 22, 2005
June 17, 2010
October 2005
September 2006   (final data collection date for primary outcome measure)
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
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) - change from baseline at week 4
Complete list of historical versions of study NCT00257660 on ClinicalTrials.gov Archive Site
  • Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and week 8 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and week 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and week 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    The number of participants considered to be overall treatment successes by the investigator at week 12 was assessed.
Subject Visual Analogue Pain Score and Subject Symptom Assessment - change from baseline at week 4
Not Provided
Not Provided
 
Randomized, Placebo-Controlled Study of AbobotulinumtoxinA (Dysport®) for the Treatment of Cervical Dystonia
A Phase III Multicentre, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Dysport® for the Treatment of Cervical Dystonia

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Cervical Dystonia
  • Drug: Botulinum type A toxin (Dysport®)
    500 units
  • Drug: Placebo
    500 units
  • Experimental: 1
    Drug: abobotulinumtoxinA (Dysport®)
    Intervention: Drug: Botulinum type A toxin (Dysport®)
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
116
September 2006
September 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Russian Federation
 
NCT00257660
Y-47-52120-051
No
Jean-Loic Robin, Ipsen
Ipsen
Not Provided
Study Director: Jean-Loic Robin Ipsen
Ipsen
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP