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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
Medy-Tox
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Dystonia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
April 24, 2012
Last Updated
September 5, 2014
Sponsor
Medy-Tox
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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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