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

NCT ID: NCT01588574

Last Updated: 2014-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-12-31

Brief Summary

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

Detailed Description

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Conditions

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Cervical Dystonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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BOTOX (registered trade mark)

Group Type ACTIVE_COMPARATOR

BOTOX(Registered trade mark)

Intervention Type BIOLOGICAL

Botulinum toxin type A

MT10109

Group Type EXPERIMENTAL

MT10109

Intervention Type BIOLOGICAL

Botulinum toxin type A

Interventions

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MT10109

Botulinum toxin type A

Intervention Type BIOLOGICAL

BOTOX(Registered trade mark)

Botulinum toxin type A

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medy-Tox

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Brisbane, , Australia

Site Status

Countries

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Australia

Other Identifiers

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MT-GPRT-CD01

Identifier Type: -

Identifier Source: org_study_id

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