Comparison of Efficacy and Safety of Two Different Types of Botulinum Toxin Type A in Moderate to Severe Cervical Dystonia
Information source: Allergan
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Spasmodic Torticollis
Intervention: botulinum toxin type A (Biological); botulinum toxin type A (Biological)
Phase: Phase 4
Status: Recruiting
Sponsored by: Allergan Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Allergan
Overall contact:
Allergan Inc, Email: clinicaltrials@allergan.com
Summary
The purpose of this study is to compare two types of botulinum toxin type A to treat the
involuntary muscle contractions in the neck
Clinical Details
Study design: Treatment, Randomized, Double Blind (Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Primary outcome: Comparison of incidence and severity of adverse events through use of a structured questionnaire and from patient interview
Secondary outcome: Efficacy as measured by TWSTRSEfficacy as measured by Cervical Dystonia Severity Efficacy as measured by Physician Global Assessment Efficacy as measured by Patient Global Assessment Efficacy as measured by Patient Assessment of Retreatment Efficacy measured by Patient Analog Assessment of Pain Efficacy measured by Physician Comparison of Benefit to Previous Injection Efficacy measured by Patient Comparison of Benefit to Previous Injection Safety as measured by Spontaneously Reported Adverse Events
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Diagnosed with cervical dystonia/spasmodic torticollis for at least 18 months
- Successfully treated previously with botulinum toxin type A
Exclusion Criteria:
- Breast feeding, pregnant or could become pregnant
- Surgery or spinal cord stimulation for cervical dystonia
- Previous injections of phenol, alcohol for cervical dystonia
Locations and Contacts
Allergan Inc, Email: clinicaltrials@allergan.com
Zagreb, Croatia; Recruiting
Krakow, Poland; Recruiting
Adelaide, South Australia, Australia; Recruiting
Additional Information
Starting date: December 2007
Ending date: February 2009
Last updated: July 7, 2009
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