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
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, see Learn About Clinical Studies.

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:
Torticollis
Dystonic Disorders
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Dystonia
Dyskinesias
Neurologic Manifestations
Signs and Symptoms
Botulinum Toxins
Botulinum Toxins, Type A
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014