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Isolated Cervical Dystonia Treatment Study

Clinical Trial Title: 
A phase 2, open-label, dose-escalating study to evaluate the safety and preliminary efficacy of a new botulinum toxin for injection in isolated cervical dystonia.
Clinical Trial Protocol ID: 
15060210
Clinical Trial Investigator Name: 
Cynthia Comella, MD
Clinical Trial Protocol Description: 

The purpose of this study is find out if a new investigational botulinum toxin for injection is safe in adults with isolated cervical dystonia (CD) and if the effects last longer than the standard toxin treatment. Participants will receive a single injection of study medication, receive routine laboratory and study safety assessments and be compensated for travel. It is anticipated that 36 subjects will enroll at up to 8 study centers; up to 6 subjects are expected to enroll at Rush University Medical Center. Participation will last about 26 week. Subjects will be asked to come to the study center up to 11 times during the study and will be contacted by telephone to answer study-specific, health-related questions up to 3 times during the study.

Clinical Trial Eligibility Criteria: 

In order to participate you must meet the following criteria:

  • Be female or male, between 30-75 years of age.
  • Have a diagnosis of isolated cervical dystonia.
  • Have never been injected with botulinum toxin for any condition, or it has been at least 6 months since last botulinum toxin injection.

You will be excluded from the study if any of the following criteria apply to you:

  • Have cervical dystonia from an underlying etiology, e.g. injury or drug-induced.
  • Have predominant retrocollis or antecollis cervical dystonia.
  • Have predominant head tremor, as judged by the study doctor.
  • Have significant dystonia in other body areas, or are currently being treated with botulinum toxin for dystonia in areas body.
  • Have a history of severe dysphagia or aspiration, or current clinically significant swallowing disorder.

This is a partial list of inclusion and exclusion criteria.

Clinical Trial Area: 
Parkinson's Disease and Other Movement Disorders
Contact Phone: 
(312) 563-2900 (Press 4/Code: Revance)
Contact Name: 
Luci Blasucci, RN