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

June 28, 2011 updated by: Allergan

Pilot Study of the Effect of Botulinum Toxin Type A Treatment on Swallowing in Patients With Cervical Dystonia

The purpose of this study is to evaluate swallowing efficiency in patients with cervical dystonia following treatment with botulinum toxin Type A.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
botulinum toxin Type A
Biological: botulinum toxin Type A
750 U at Visit 1
Other Names:
  • Dysport®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in Oropharyngeal Swallow Efficiency (OPSE)
Time Frame: Baseline, Week 2
Baseline, Week 2

Secondary Outcome Measures

Outcome Measure
Time Frame
Toronto Western Spasmodic Torticollis Scale (TWSTRS) Total Score
Time Frame: Week 4
Week 4
Physician Assessment of Cervical Dystonia Severity
Time Frame: Week 4
Week 4
Global Assessment of Benefit by Physician
Time Frame: Week 4
Week 4
Global Assessment of Benefit by Patient
Time Frame: Week 4
Week 4
Patient Visual Analog Assessment of Pain
Time Frame: Week 4
Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

June 27, 2011

First Submitted That Met QC Criteria

June 28, 2011

First Posted (Estimate)

June 29, 2011

Study Record Updates

Last Update Posted (Estimate)

June 29, 2011

Last Update Submitted That Met QC Criteria

June 28, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MedAff-BTX-0716

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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