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

This study has been completed.
Sponsor:
Information provided by:
Allergan
ClinicalTrials.gov Identifier:
NCT01384214
First received: June 27, 2011
Last updated: June 28, 2011
Last verified: June 2011
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toronto Western Spasmodic Torticollis Scale (TWSTRS) Total Score [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Physician Assessment of Cervical Dystonia Severity [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Global Assessment of Benefit by Physician [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Global Assessment of Benefit by Patient [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Patient Visual Analog Assessment of Pain [ Time Frame: Week 4 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01384214

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

No publications provided

Responsible Party: Vice President Medical Affairs, Allergan, Inc.
ClinicalTrials.gov Identifier: NCT01384214     History of Changes
Other Study ID Numbers: MedAff-BTX-0716
Study First Received: June 27, 2011
Last Updated: June 28, 2011
Health Authority: Croatia: Ministry of Health and Social Care

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, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 23, 2014