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Comparison of Efficacy and Safety of Two Different Types of Botulinum Toxin Type A in Moderate to Severe Cervical Dystonia

NCT ID: NCT00528541

Last Updated: 2011-12-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

145 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2009-09-30

Brief Summary

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The purpose of this study is to compare two types of botulinum toxin type A to treat the involuntary muscle contractions in the neck

Detailed Description

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Conditions

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Spasmodic Torticollis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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BOTOX®

botulinum toxin type A (BOTOX®)

Group Type ACTIVE_COMPARATOR

botulinum toxin type A

Intervention Type BIOLOGICAL

200 Units at Visit 1 (Day 1)

Dysport®

botulinum toxin type A (Dysport®)

Group Type ACTIVE_COMPARATOR

botulinum toxin type A

Intervention Type BIOLOGICAL

750 Units at Visit 1 (Day 1)

Interventions

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botulinum toxin type A

200 Units at Visit 1 (Day 1)

Intervention Type BIOLOGICAL

botulinum toxin type A

750 Units at Visit 1 (Day 1)

Intervention Type BIOLOGICAL

Other Intervention Names

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BOTOX® Dysport®

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with cervical dystonia/spasmodic torticollis for at least 18 months
* Successfully treated previously with botulinum toxin type A

Exclusion Criteria

* Breast feeding, pregnant or could become pregnant
* Surgery or spinal cord stimulation for cervical dystonia
* Previous injections of phenol, alcohol for cervical dystonia
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

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Adelaide, South Australia, Australia

Site Status

Zagreb, , Croatia

Site Status

Rome, , Italy

Site Status

Krakow, , Poland

Site Status

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Australia Croatia Italy Poland Turkey (Türkiye)

Other Identifiers

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MedAff-BTX-0616

Identifier Type: -

Identifier Source: org_study_id