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Comparison of Efficacy and Safety of Two Different Types of Botulinum Toxin Type A in Moderate to Severe Cervical Dystonia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00528541
First received: September 10, 2007
Last updated: November 14, 2011
Last verified: November 2011
Results First Received: November 14, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Spasmodic Torticollis
Intervention: Biological: botulinum toxin type A

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
BOTOX® botulinum toxin type A (BOTOX®)
Dysport® botulinum toxin type A (Dysport®)

Participant Flow:   Overall Study
    BOTOX®     Dysport®  
STARTED     75     70  
COMPLETED     73     69  
NOT COMPLETED     2     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.
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Reporting Groups
  Description
BOTOX® botulinum toxin type A (BOTOX®)
Dysport® botulinum toxin type A (Dysport®)
Total Total of all reporting groups

Baseline Measures
    BOTOX®     Dysport®     Total  
Number of Participants  
[units: participants]
  75     70     145  
Age  
[units: years]
Mean ± Standard Deviation
  49.4  ± 12.2     48.6  ± 11.5     49.0  ± 11.9  
Gender  
[units: participants]
     
Female     46     39     85  
Male     29     31     60  



  Outcome Measures
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1.  Primary:   Dysphagia Incidence Over 10 Weeks   [ Time Frame: 10 weeks ]

2.  Secondary:   Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score at Week 4   [ Time Frame: Baseline, Week 4 ]

3.  Secondary:   Physician Assessment of Cervical Dystonia Severity at Week 4   [ Time Frame: Baseline, Week 4 ]

4.  Secondary:   Global Assessment of Benefit by Physician at Week 4   [ Time Frame: Week 4 ]

5.  Secondary:   Global Assessment of Benefit by Patient at Week 4   [ Time Frame: Week 4 ]

6.  Secondary:   Patient Assessment of Need for Retreatment at Week 4   [ Time Frame: Baseline, Week 4 ]

7.  Secondary:   Patient Visual Analog Assessment of Pain at Week 4   [ Time Frame: Baseline, Week 4 ]

8.  Secondary:   Physician Comparison of Benefit to Previous Injections at Week 10   [ Time Frame: Week 10 ]

9.  Secondary:   Patient Comparison of Benefit to Previous Injections at Week 10   [ Time Frame: Week 10 ]


  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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Vice President Medical Affairs
Organization: Allergan, Inc.
phone: 714-246-4500
e-mail: clinicaltrials@allergan.com


No publications provided


Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00528541     History of Changes
Other Study ID Numbers: MedAff-BTX-0616
Study First Received: September 10, 2007
Results First Received: November 14, 2011
Last Updated: November 14, 2011
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration