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Efficacy and Safety of DYSPORT® Using 2mL Dilution in Adults With Cervical Dystonia.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01753310
First received: December 17, 2012
Last updated: January 26, 2017
Last verified: January 2017

December 17, 2012
January 26, 2017
January 2013
October 2014   (Final data collection date for primary outcome measure)
Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score at Week 4. [ Time Frame: 4 weeks post-treatment ]
The change from baseline in the TWSTRS total score at Week 4 was determined for the subjects who received a single dose of Dysport® or placebo by intramuscular injection at the baseline visit (Day 1), and is expressed as weighted overall treatment difference. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The score was assessed by the investigator prior to study treatment at baseline and at all post-treatment visits.
Change from baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score [ Time Frame: 4 weeks post-treatment ]
Complete list of historical versions of study NCT01753310 on ClinicalTrials.gov Archive Site
  • Change From Baseline in TWSTRS Total Score at Week 2. [ Time Frame: 2 weeks post-treatment ]
    The change from baseline in the TWSTRS total score at Week 2 was determined for the subjects who received a single dose of Dysport® or placebo by intramuscular injection at the baseline visit (Day 1), and is expressed as weighted overall treatment difference. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The score was assessed by the investigator prior to study treatment at baseline and at all post-treatment visits.
  • Change From Baseline in Clinical Global Impression of Change (CGIC) in CD at Week 2. [ Time Frame: 2 weeks post-treatment ]
    The CGIC is an investigator-reported assessment of the global clinical change in CD since study treatment administration. The CGIC uses a seven-point Likert scale ranging from +3 (very much improved) to -3 (very much worse), and was assessed by the investigator at the Week 2 and Week 4 visits.
  • TWSTRS Responders at Week 2. [ Time Frame: 2 weeks post-treatment ]
    Treatment response was determined as the number of responders at Week 2 relative to the baseline TWSTRS total score. A treatment responder is defined as a subject who had at least a 30% reduction in the TWSTRS total score after treatment. This was calculated as ([Week 2 score - baseline score]/baseline score) * 100.
  • Change From Baseline in CGIC in CD at Week 4. [ Time Frame: 4 weeks post-treatment ]
    The CGIC is an investigator-reported assessment of the global clinical change in CD since study treatment administration. The CGIC uses a seven-point Likert scale ranging from +3 (very much improved) to -3 (very much worse), and was assessed by the investigator at the Week 2 and Week 4 visits.
  • TWSTRS Responders at Week 4. [ Time Frame: 4 weeks post-treatment ]
    Treatment response was determined as the number of responders at Week 4 relative to the baseline TWSTRS total score. A treatment responder is defined as a subject who had at least a 30% reduction in the TWSTRS total score after treatment. This was calculated as ([Week 4 score - baseline score]/baseline score) * 100.
  • Change From Baseline in Cervical Dystonia Impact Profile-58 (CDIP-58) Total Score at Week 4. [ Time Frame: 4 weeks post-treatment ]
    The CDIP-58 scale is a subject-based rating scale measuring the health impact of CD measured in 8 health dimensions including head and neck symptoms, pain and discomfort, upper limb activities, walking, sleep, annoyance, mood and psychosocial functioning. Subscale scores were transformed to a common theoretical range of 0 (no impact) to 100 (most impact). Negative changes from the baseline total score indicate improvement in the impact of CD on health whereas postive changes indicate worsening.
  • Change From Baseline in CDIP-58 Total Score at Week 2. [ Time Frame: 2 weeks post-treatment ]
    The CDIP-58 scale is a subject-based rating scale measuring the health impact of CD measured in 8 health dimensions including head and neck symptoms, pain and discomfort, upper limb activities, walking, sleep, annoyance, mood and psychosocial functioning. Subscale scores were transformed to a common theoretical range of 0 (no impact) to 100 (most impact). Negative changes from the baseline total score indicate improvement in the impact of CD on health whereas postive changes indicate worsening. The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint (change from baseline in CDIP-58 total score at Week 4) reached a statistically significant treatment effect. This secondary efficacy endpoint (change from baseline in CDIP-58 total score at Week 2) was performed to characterise the full clinical effect.
  • Change from baseline in TWSTRS total score [ Time Frame: Baseline and 2 weeks post-treatment ]
  • Clinical Global Impression of Change (CGIC) in Cervical Dystonia [ Time Frame: 2 and 4 weeks post-treatment ]
  • Treatment response [ Time Frame: 2 and 4 weeks post-treatment ]
    A treatment responder is defined as a subject who had at least a 30% reduction in the TWSTRS total score after treatment.
  • Change in Cervical Dystonia Impact Profile-58 (CDIP-58) score [ Time Frame: 2 and 4 weeks post-treatment ]
Not Provided
Not Provided
 
Efficacy and Safety of DYSPORT® Using 2mL Dilution in Adults With Cervical Dystonia.
A Phase 3b, Multicentre, Randomised, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of DYSPORT® Using 2mL Dilution in Adults With Cervical Dystonia.
The purpose of the protocol is to evaluate the efficacy and safety of Dysport® using 2 mL dilution compared with placebo for the treatment of Cervical Dystonia.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Cervical Dystonia
  • Drug: Dysport®
    Intramuscular injection, between 250 and 500 units (U)/vial using 2mL dilution, 1 cycle only
    Other Name: AbobotulinumtoxinA (non-proprietary name)
  • Drug: Placebo
    Up to 2mL
  • Active Comparator: Dysport®
    Dysport® (intramuscular injection), between 250 and 500 units (U)/vial using 2mL dilution, 1 cycle only
    Intervention: Drug: Dysport®
  • Placebo Comparator: Placebo
    Placebo, up to 2mL
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
134
January 2015
October 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Primary diagnosis of Cervical Dystonia at least 9 months since onset and either previously untreated with botulinum toxin or currently treated with Botox at a total dosing range of 100-200 U and ≤60 U in the sternocleidomastoid muscle at the last injection cycle, and having had a satisfactory treatment response in the principal investigator's judgment during the last two sequential Botox treatment cycles.
  • TWSTRS total score≥ 20; TWSTRS-severity subscale score> 10;

Exclusion Criteria:

  • In apparent remission from Cervical Dystonia
  • Diagnosis of pure retrocollis or pure anterocollis
  • For non-naïve subjects, previous poor response to either of the last two Botox treatments
  • Known requirement of <100U or >200U of Botox injected into the neck muscles
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01753310
A-TL-52120-169
No
Not Provided
Not Provided
Not Provided
Ipsen
Ipsen
Not Provided
Study Director: Medical Director, Neurology, M.D. Ipsen
Ipsen
January 2017

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