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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
Results First Received: November 8, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Investigator;   Primary Purpose: Treatment
Condition: Cervical Dystonia
Interventions: Drug: Dysport®
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First subject enrolled: 7 January 2013; last subject completed: 9 January 2015. 46 investigational sites in the United States of America were planned, 43 sites were initiated and 38 sites enrolled adult subjects with cervical dystonia (CD).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
150 subjects were screened; 16 subjects failed screening. 134 subjects were enrolled (signed informed consent) and were randomised with a 2:1 ratio of Dysport®:placebo. Randomisation was also stratified for subjects who were Botulinum toxin type A (BoNT-A) treatment naive or non-naive at baseline.

Reporting Groups
  Description
Dysport® Subjects were randomised to receive a single intramuscular injected dose of study medication, Dysport® 500 U/vial using a 2 mL dilution scheme. The dose of Dysport® was between 250 U and 500 U divided among a minimum of two clinically indicated muscles. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-hemagglutinin complex (abobotulinumtoxinA).
Placebo Subjects were randomised to receive a single dose of placebo by intramuscular injection. The placebo was provided in glass vials indistinguishable from the Dysport® vials. The placebo contained only the excipients used in Dysport® without the toxin, provided as a white lyophilised powder for reconstitution with the same storage and preparation conditions as for Dysport®.

Participant Flow:   Overall Study
    Dysport®   Placebo
STARTED   89   45 
COMPLETED   57   21 
NOT COMPLETED   32   24 
Entered into open label extension study                25                22 
Adverse Event                1                0 
Lost to Follow-up                2                0 
Subject decision                2                2 
Sponsor decision                1                0 
Withdrawal by Subject                1                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The baseline characteristics are presented for the Intent to Treat (ITT) Population which consisted of all randomised subjects.

Reporting Groups
  Description
Dysport® Subjects were randomised to receive a single intramuscular injected dose of study medication, Dysport® 500 U/vial using a 2 mL dilution scheme. The dose of Dysport® was between 250 U and 500 U divided among a minimum of two clinically indicated muscles. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-hemagglutinin complex (abobotulinumtoxinA).
Placebo Subjects were randomised to receive a single dose of placebo by intramuscular injection. The placebo was provided in glass vials indistinguishable from the Dysport® vials. The placebo contained only the excipients used in Dysport® without the toxin, provided as a white lyophilised powder for reconstitution with the same storage and preparation conditions as for Dysport®.
Total Title No text entered.

Baseline Measures
   Dysport®   Placebo   Total Title 
Overall Participants Analyzed 
[Units: Participants]
 89   45   134 
Age, Customized 
[Units: Participants]
     
18-24 years   0   0   0 
25-34 years   2   2   4 
35-44 years   9   4   13 
45-54 years   26   14   40 
55-64 years   26   12   38 
65-74 years   22   11   33 
>75 years   4   2   6 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      59  66.3%      28  62.2%      87  64.9% 
Male      30  33.7%      17  37.8%      47  35.1% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score at Week 4.   [ Time Frame: 4 weeks post-treatment ]

2.  Secondary:   Change From Baseline in TWSTRS Total Score at Week 2.   [ Time Frame: 2 weeks post-treatment ]

3.  Secondary:   Change From Baseline in Clinical Global Impression of Change (CGIC) in CD at Week 2.   [ Time Frame: 2 weeks post-treatment ]

4.  Secondary:   TWSTRS Responders at Week 2.   [ Time Frame: 2 weeks post-treatment ]

5.  Secondary:   Change From Baseline in CGIC in CD at Week 4.   [ Time Frame: 4 weeks post-treatment ]

6.  Secondary:   TWSTRS Responders at Week 4.   [ Time Frame: 4 weeks post-treatment ]

7.  Secondary:   Change From Baseline in Cervical Dystonia Impact Profile-58 (CDIP-58) Total Score at Week 4.   [ Time Frame: 4 weeks post-treatment ]

8.  Secondary:   Change From Baseline in CDIP-58 Total Score at Week 2.   [ Time Frame: 2 weeks post-treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Medical Director
Organization: Ipsen Biopharmaceuticals, Inc.
e-mail: clinical.trials@ipsen.com



Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT01753310     History of Changes
Other Study ID Numbers: A-TL-52120-169
Study First Received: December 17, 2012
Results First Received: November 8, 2016
Last Updated: January 26, 2017