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Clinical Trails at Rush Cervical Dystonia Study
Clinical Trial Protocol ID
07120501

Clinical Trial Investigator Name
Cynthia Comella

Clinical Trial Title

Treatment for Cervical Dystonia



Clinical Trial Protocol Description

Cervical dystonia or CD, also known as spasmodic torticollis is characterized by abnormal movements or postures of the neck and head. Although CD may become apparent at any age, symptoms usually begin between 20 to 60 years. Women are affected approximately twice as common as men are.  The purpose of this study is to test the safety and effectiveness of an investigational drug in the treatment of cervical dystonia. Men and women between the ages of 18 and 75 who have never been treated with injections of Botox or Myobloc may quality for participation in this study.  Qualified subjects will be asked to complete 3 treatment sessions over the course of approximately 1 year and will have to come for study visits at Rush University Medical Center.



Clinical Trial Eligibility Criteria

You may be eligible to participate in this study if you:

  • Are 18-75 years of age with clinically diagnosed idiopathic cervical dystonia or segmental or generalized dystonia in which cervical dystonia is the predominant feature
  • Have the knowledge and ability (were it not for the cervical dystonia) to participate in all activities except driving mentioned in the TWSTRS Disability subscale
  • Are evaluated by the study doctor using the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) and various scores must be within range according to study entry criteria
  • Either have not been treated for your cervical dystonia (CD) within 6 weeks prior to Day 1 or your existing treatment for CD is stable (i.e. no changes within 6 weeks) prior to Day 1 (randomization) and is anticipated to remain stable throughout the study, including any pharmacological  or non-pharmacological treatment

You will be excluded from this study if you:

  • Have an uncontrolled medical condition other than the condition under evaluation
  • Have concurrent or have had previous botulinum toxin treatment of any serotype for any condition, or immunization to any botulinum toxin serotype
  • Have certain medical condition that would exclude your from participation
  • Have a known allergy or sensitivity to the study medication(s) or its components
  • Have had previous surgical procedure involving bone or muscle for the management of cervical dystonia
  • Have had previous injections of phenol or alcohol that, in the investigator's opinion, have altered muscle anatomy

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via e-mail, please include the title of the study in your message.





Contact Name Luci Blasucci
Contact Phone (312) 563-2900 x4
Contact E-mail clinical_trials@rush.edu
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