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

Medytox

Status and phase: Completed; Phase 2

Conditions: Cervical Dystonia

Treatments: Biological: MT10109; Biological: BOTOX(Registered trade mark)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01588574

MT-GPRT-CD01

Details and patient eligibility

About

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

Enrollment: 60 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

BOTOX (registered trade mark)

Active Comparator group

Treatment:

Biological: BOTOX(Registered trade mark)

MT10109

Experimental group

Treatment:

Biological: MT10109