MedDataX Logo

Efficacy and Safety of Two Different Botulinum Toxin Type A Treatments for Moderate to Severe Cervical Dystonia

NCT ID: NCT00432341

Last Updated: 2011-12-16

Study Results

Results available

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

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2009-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Spasmodic Torticollis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

BOTOX®

Botulinum toxin type A (BOTOX®)

Group Type EXPERIMENTAL

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

500 Units at Visit 1 (Day 1)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

botulinum toxin type A

200 Units at Visit 1 (Day 1)

Intervention Type BIOLOGICAL

botulinum toxin type A

500 Units at Visit 1 (Day 1)

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

BOTOX® Dysport®

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Buenos Aires, , Argentina

Site Status

Parkville, Victoria, Australia

Site Status

New Delhi, New Delhi, India

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Argentina Australia India

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MedAff-BTX-0615

Identifier Type: -

Identifier Source: org_study_id