Study for Determine the Safety and Efficacy of Clostridium Botulinum Toxin Type A in Subjects With Cervical Dystonia
Primary Purpose
Cervical Dystonia
Status
Completed
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
MT10109
BOTOX(Registered trade mark)
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Dystonia
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
BOTOX (registered trade mark)
MT10109
Arm Description
Outcomes
Primary Outcome Measures
Number of adverse events
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01588574
Brief Title
Study for Determine the Safety and Efficacy of Clostridium Botulinum Toxin Type A in Subjects With Cervical Dystonia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medy-Tox
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine the Optimal dose for safety and efficacy in the treatment of cervical dystonia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Dystonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BOTOX (registered trade mark)
Arm Type
Active Comparator
Arm Title
MT10109
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
MT10109
Intervention Description
Botulinum toxin type A
Intervention Type
Biological
Intervention Name(s)
BOTOX(Registered trade mark)
Intervention Description
Botulinum toxin type A
Primary Outcome Measure Information:
Title
Number of adverse events
Time Frame
Day 30
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
City
Brisbane
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
Study for Determine the Safety and Efficacy of Clostridium Botulinum Toxin Type A in Subjects With Cervical Dystonia
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