Trial record 1 of 1 for:    A-TL-52120-170
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An Open-Label Extension Study To Assess Long Term Safety And Effectiveness Of Dysport In Adults With Cervical Dystonia (CD)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01753336
First received: December 17, 2012
Last updated: August 21, 2014
Last verified: August 2014

December 17, 2012
August 21, 2014
July 2013
November 2014   (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 ]
Same as current
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 ]
  • 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 ]
Same as current
Not Provided
Not Provided
 
An Open-Label Extension Study To Assess Long Term Safety And Effectiveness Of Dysport In Adults With Cervical Dystonia (CD)
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

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.
 
Enrolling by invitation
100
November 2014
November 2014   (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
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01753336
A-TL-52120-170
No
Ipsen
Ipsen
Not Provided
Study Director: Kathleen G Lomax, M.D. Ipsen
Ipsen
August 2014

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