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

Phase 2

Completed

• Conditions: Cervical Dystonia
• Interventions: Biological: BOTOX(Registered trade mark); Biological: MT10109

• Registration Number: NCT01588574
• Lead Sponsor: Medy-Tox

Brief Summary

The purpose of this study is to determine the Optimal dose for safety and efficacy in the treatment of cervical dystonia.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-04-24
• Study First Submitted QC: 2012-04-27
• Study First Posted: 2012-05-01
• Study Start: 2012-08
• Status Verified: 2013-02
• Primary Completion: 2013-10
• Study Completion: 2013-12
• Last Update Submitted: 2014-09-05
• Last Update Posted: 2014-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BOTOX (registered trade mark)	BOTOX(Registered trade mark)	-
MT10109	MT10109	-

Primary Outcome Measures

Name	Time	Method
Number of adverse events	Day 30