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Trial record 1 of 1 for:    A-TL-52120-170
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Long Term Safety And Effectiveness Of Dysport® In Adults With Cervical Dystonia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01753336
First Posted: December 20, 2012
Last Update Posted: May 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ipsen
Results First Submitted: January 12, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Cervical Dystonia
Intervention: Drug: Dysport®

  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
This was an open label extension (OLE) study for study A-TL-52120-169 (Study 169). First subject enrolled: 14 March 2013; last subject completed: 13 October 2015. A-TL-52120-170 (Study 170) was conducted in 36 centres in the United States that had participated in Study 169 and 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
Subjects who completed Study 169 and had no on-going Adverse Events (AEs) or whose Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score between Weeks 4 and 8 was reduced by ≤15% from baseline were invited to participate in this OLE study. 112 of the 134 subjects in Study 169 were enrolled into Study 170 (signed informed consent).

Reporting Groups
  Description
Total Dysport® Subjects received up to 3 doses of Dysport® 500 Units (U)/vial, 2 millilitre (mL) dilution on Day 1 of up to 3 treatment cycles. Subjects who were botulinum neurotoxin (BoNT) treatment naïve at the start of Study 169 received a starting dose of 500 U/2 mL Dysport®, and subjects who were non-naïve to BoNT treatment received the same dose they had received on Day 1 of Study 169. Subjects received Dysport® by intramuscular injection into the same neck muscles that had been used for injection in Study 169. Retreatment occurred every 12 to 16 weeks, dependent on the investigator's clinical judgment. Follow-up visits occurred at Weeks 4 and 12 of each treatment cycle. Subjects were determined to have completed the study at Week 12 of Treatment Cycle 3. Dysport® contains the neurotoxin Clostridium botulinum toxin type A haemagglutinin complex (abobotulinumtoxinA).

Participant Flow:   Overall Study
    Total Dysport®
STARTED   112 
Cycle 1   112 
Cycle 2   98 
Cycle 3   93 
COMPLETED   92 
NOT COMPLETED   20 
Patient decision                12 
Lost to Follow-up                3 
Physician Decision                2 
Sponsor's decision                2 
Withdrawal by Subject                1 



  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 safety population included all subjects who received at least 1 dose of study treatment, regardless of the amount of study treatment administered, and who had at least 1 safety record post-treatment or attended a post-treatment visit.

Reporting Groups
  Description
Total Dysport® Subjects received up to 3 doses of Dysport® 500 U/vial, 2 mL dilution on Day 1 of up to 3 treatment cycles. Subjects who were BoNT treatment naïve at the start of Study 169 received a starting dose of 500U/2 mL Dysport®, and subjects who were non-naïve to BoNT treatment received the same dose they had received on Day 1 of Study 169. Subjects received Dysport® by intramuscular injection into the same neck muscles that had been used for injection in Study 169. Retreatment occurred every 12 to 16 weeks, dependent on the investigator's clinical judgment. Follow-up visits occurred at Weeks 4 and 12 of each treatment cycle. Subjects were determined to have completed the study at Week 12 of Treatment Cycle 3. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).

Baseline Measures
   Total Dysport® 
Overall Participants Analyzed 
[Units: Participants]
 112 
Age, Customized 
[Units: Participants]
 
18-24 years   0 
25-34 years   1 
35-44 years   13 
45-54 years   34 
55-64 years   33 
65-74 years   26 
+75 years   5 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      70  62.5% 
Male      42  37.5% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   TWSTRS Total Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3.   [ Time Frame: Week 4 and 12 of treatment cycles 1, 2 and 3 (12 - 16 weeks duration each) ]

2.  Secondary:   TWSTRS Total Scores at Pretreatment Baseline, Week 4 and Week 12 for Treatment Cycles 1, 2 and 3.   [ Time Frame: Week 4 and 12 of treatment cycles 1, 2 and 3 (12 - 16 weeks duration each) ]

3.  Secondary:   Treatment Response in Treatment Cycle 3 Week 4.   [ Time Frame: Week 4 Treatment Cycle 3 ]

4.  Secondary:   TWSTRS Severity Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3.   [ Time Frame: Weeks 4 and 12 of treatment cycle 1, 2 and 3 (12 - 16 weeks duration each) ]

5.  Secondary:   TWSTRS Disability Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3.   [ Time Frame: Weeks 4 and 12 of treatment cycle 1, 2 and 3 (12 - 16 weeks duration each) ]

6.  Secondary:   TWSTRS Pain Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3.   [ Time Frame: Week 4 and 12 of treatment cycles 1, 2 and 3 (12 - 16 weeks duration each) ]


  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: NCT01753336     History of Changes
Other Study ID Numbers: A-TL-52120-170
First Submitted: December 17, 2012
First Posted: December 20, 2012
Results First Submitted: January 12, 2017
Results First Posted: May 4, 2017
Last Update Posted: May 4, 2017