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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medy-Tox
ClinicalTrials.gov Identifier:
NCT01588574
First received: April 24, 2012
Last updated: September 5, 2014
Last verified: February 2013

April 24, 2012
September 5, 2014
August 2012
October 2013   (final data collection date for primary outcome measure)
Number of adverse events [ Time Frame: Day 30 ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT01588574
MT-GPRT-CD01
Yes
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