Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Trial record 1 of 1 for:    A-TL-52120-170
Previous Study | Return to List | Next Study

Long Term Safety And Effectiveness Of Dysport In Adults With Cervical Dystonia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01753336
First received: December 17, 2012
Last updated: December 21, 2015
Last verified: December 2015

December 17, 2012
December 21, 2015
July 2013
October 2015   (final data collection date for primary outcome measure)
Change from treatment cycle baseline (defined as Day 1 in each cycle) in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score [ Time Frame: Week 4 and Week 12 visits ] [ Designated as safety issue: No ]
Data from treatment cycles 1, 2 and 3 will be used in the analysis.
Change from treatment cycle baseline (defined as Day 1 in each cycle) in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score [ Time Frame: Week 4 and Week 12 visits ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01753336 on ClinicalTrials.gov Archive Site
  • Change from baseline (defined as the measurement before Dysport treatment in Study 169) in TWSTRS total score [ Time Frame: Week 4 and Week 12 visits ] [ Designated as safety issue: No ]
    Data from treatment cycles 1, 2 and 3 will be used in the analysis.
  • Treatment response in Treatment Cycle 3 [ Time Frame: Baseline and Week 4 visit ] [ Designated as safety issue: No ]
    A treatment responder is defined as a subject who had at least a 30% reduction from baseline in the TWSTRS total score after treatment.
  • Change from treatment cycle baseline in TWSTRS severity subscale score [ Time Frame: Week 4 and Week 12 ] [ Designated as safety issue: No ]
    Data from treatment cycles 1, 2 and 3 will be used in the analysis.
  • Change from treatment cycle baseline in TWSTRS disability subscale score [ Time Frame: Week 4 and Week 12 ] [ Designated as safety issue: No ]
    Data from treatment cycles 1, 2 and 3 will be used in the analysis.
  • Change from treatment cycle baseline in TWSTRS pain subscale score [ Time Frame: Week 4 and Week 12 ] [ Designated as safety issue: No ]
    Data from treatment cycles 1, 2 and 3 will be used in the analysis.
  • Change from baseline (defined as the measurement before Dysport treatment in Study 169) in TWSTRS total score [ Time Frame: Week 4 and Week 12 visits ] [ Designated as safety issue: No ]
  • Treatment response in Treatment Cycle 3 [ Time Frame: Baseline and Week 4 visit ] [ Designated as safety issue: No ]
    A treatment responder is defined as a subject who had at least a 30% reduction from baseline in the TWSTRS total score after treatment.
  • Change from treatment cycle baseline in TWSTRS severity subscale score [ Time Frame: Week 4 and Week 12 ] [ Designated as safety issue: No ]
  • Change from treatment cycle baseline in TWSTRS disability subscale score [ Time Frame: Week 4 and Week 12 ] [ Designated as safety issue: No ]
  • Change from treatment cycle baseline in TWSTRS pain subscale score [ Time Frame: Week 4 and Week 12 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Long Term Safety And Effectiveness Of Dysport In Adults With Cervical Dystonia
A Phase IIIb, Prospective, Multicentre, Open-Label Extension Study To Assess Long Term Safety And Effectiveness Of Dysport Using 2 mL Dilution In Adults With Cervical Dystonia
The purpose of the protocol is to assess the long term safety of repeat treatment cycles of Dysport 500 U using 2 mL dilution scheme for the treatment of Cervical Dystonia. This is an extension study to study A-TL-52120-169 (hereafter referred to as Study 169).
Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Cervical Dystonia
Drug: Dysport
Dysport (intramuscular injection), Up to 500 units (U)/vial using 2mL dilution, 3 treatment cycles
Experimental: Dysport
Dysport, up to 500 units (U)/vial using 2mL dilution
Intervention: Drug: Dysport
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
112
October 2015
October 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects enrolled in Study 169 that have no ongoing adverse events, which in the opinion of the Investigator are related to study treatment and that precludes them from receiving continuing therapy
  • Completed Study 169, or completed all study visits up to and including Week 4 and in the event of an early withdrawal after Week 4 have ≤15% reduction in TWSTRS total score at Week 4 compared to their baseline TWSTRS total score in the double-blind study, and in the Investigator's clinical judgment, would benefit from Dysport for CD.

Exclusion Criteria:

  • Diagnosis of pure retrocollis or pure anterocollis
  • Requirement for botulinum toxin injection to site(s) for disorders other than CD and unable to avoid such treatment(s) for the duration of the study
  • Known hypersensitivity to botulinum toxin or related compounds, or any component in the study drug formulation
  • Allergy to cow's milk protein
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01753336
A-TL-52120-170
No
Not Provided
Not Provided
Ipsen
Ipsen
Not Provided
Study Director: Medical Director Neurology, M.D. Ipsen
Ipsen
December 2015

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