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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01588574

Enrollment

Registered

2012-05-01

Start date

2012-08-31

Completion date

2013-12-31

Last updated

2014-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Dystonia

Brief summary

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

Interventions

BIOLOGICALMT10109

Botulinum toxin type A

BIOLOGICALBOTOX(Registered trade mark)

Botulinum toxin type A

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
Number of adverse events	Day 30

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026