Effect of Botulinum Toxin Type A on Swallowing in Patients With Cervical Dystonia

NCT ID: NCT01384214

Last Updated: 2011-06-29

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

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

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

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 evaluate swallowing efficiency in patients with cervical dystonia following treatment with botulinum toxin Type A.

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.

Torticollis

Study Design

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

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

1

botulinum toxin Type A

Group Type EXPERIMENTAL

botulinum toxin Type A

Intervention Type BIOLOGICAL

750 U at Visit 1

Interventions

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

botulinum toxin Type A

750 U at Visit 1

Intervention Type BIOLOGICAL

Other Intervention Names

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

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
* Successfully completed Allergan study MedAff BTX-0616 with 16 weeks since last botulinum toxin Type A injection
* In need of additional botulinum toxin Type A injections

Exclusion Criteria

* Surgery or spinal cord stimulation for cervical dystonia
* Previous injections of phenol or 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.

Allergan, Inc.

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.

Zagreb, , Croatia

Site Status

Countries

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

Croatia

Other Identifiers

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

MedAff-BTX-0716

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Assessing Cervical Dystonia
NCT03587350 COMPLETED NA
Botulinum Toxin Injection Efficiency
NCT01041157 UNKNOWN PHASE1