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Completed

NCT Number: NCT01384214

Effect of Botulinum Toxin Type A 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.

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Key information

Conditions

Torticollis Dyskinesias Dystonia Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Zagreb, Croatia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Botulinum toxin type A

Biological

750 U at Visit 1

Other names: Dysport®

Primary outcomes

  1. Change from Baseline in Oropharyngeal Swallow Efficiency (OPSE)

    Time frame: Baseline, Week 2

Secondary outcomes

  1. Toronto Western Spasmodic Torticollis Scale (TWSTRS) Total Score

    Time frame: Week 4

  2. Physician Assessment of Cervical Dystonia Severity

    Time frame: Week 4

  3. Global Assessment of Benefit by Physician

    Time frame: Week 4

  4. Global Assessment of Benefit by Patient

    Time frame: Week 4

  5. Patient Visual Analog Assessment of Pain

    Time frame: Week 4

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jun 29, 2011
Registry last updated
Jun 29, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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