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

Cervical Dystonia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01588574
• Other study ID #: MT-GPRT-CD01
• Status: Completed
• Phase: Phase 2
• First received: April 24, 2012
• Last updated: September 5, 2014
• Start date: August 2012
• Est. completion date: December 2013

Study information

• Verified date: February 2013
• Source: Medy-Tox
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Dystonia
• Dystonia
• Dystonic Disorders

Intervention

Biological:
• MT10109
Botulinum toxin type A
• BOTOX(Registered trade mark)
Botulinum toxin type A

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medy-Tox

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of adverse events		Day 30	Yes