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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01384214
First Posted: June 29, 2011
Last Update Posted: June 29, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Allergan
  Purpose
The purpose of this study is to evaluate swallowing efficiency in patients with cervical dystonia following treatment with botulinum toxin Type A.

Condition Intervention Phase
Torticollis Biological: botulinum toxin Type A Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of the Effect of Botulinum Toxin Type A Treatment on Swallowing in Patients With Cervical Dystonia

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Change from Baseline in Oropharyngeal Swallow Efficiency (OPSE) [ Time Frame: Baseline, Week 2 ]

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

Enrollment: 28
Study Start Date: October 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
botulinum toxin Type A
Biological: botulinum toxin Type A
750 U at Visit 1
Other Name: Dysport®

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01384214


Locations
Croatia
Zagreb, Croatia
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

Responsible Party: Vice President Medical Affairs, Allergan, Inc.
ClinicalTrials.gov Identifier: NCT01384214     History of Changes
Other Study ID Numbers: MedAff-BTX-0716
First Submitted: June 27, 2011
First Posted: June 29, 2011
Last Update Posted: June 29, 2011
Last Verified: June 2011

Additional relevant MeSH terms:
Dystonia
Torticollis
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Dystonic Disorders
Movement Disorders
Central Nervous System Diseases
Botulinum Toxins
Botulinum Toxins, Type A
onabotulinumtoxinA
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents