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Study for Determine the Safety and Efficacy of Clostridium Botulinum Toxin Type A in Subjects With Cervical Dystonia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01588574
First Posted: May 1, 2012
Last Update Posted: September 8, 2014
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):
Medy-Tox
April 24, 2012
May 1, 2012
September 8, 2014
August 2012
October 2013   (Final data collection date for primary outcome measure)
Number of adverse events [ Time Frame: Day 30 ]
Same as current
Complete list of historical versions of study NCT01588574 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study for Determine the Safety and Efficacy of Clostridium Botulinum Toxin Type A in Subjects With Cervical Dystonia
Not Provided
The purpose of this study is to determine the Optimal dose for safety and efficacy in the treatment of cervical dystonia.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Cervical Dystonia
  • Biological: MT10109
    Botulinum toxin type A
  • Biological: BOTOX(Registered trade mark)
    Botulinum toxin type A
  • Active Comparator: BOTOX (registered trade mark)
    Intervention: Biological: BOTOX(Registered trade mark)
  • Experimental: MT10109
    Intervention: Biological: MT10109
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
December 2013
October 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female aged 18~75
  • Have no clinically significant medical condition
  • Cervical dystonia

Exclusion Criteria:

  • Pregnant or lactation
  • Subjects who have been administered the following drugs within the previous 1 month
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
 
NCT01588574
MT-GPRT-CD01
Yes
Not Provided
Not Provided
Medy-Tox
Medy-Tox
Not Provided
Not Provided
Medy-Tox
February 2013

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