Efficacy and Safety of Two Different Botulinum Toxin Type A Treatments for Moderate to Severe Cervical Dystonia
Information source: Allergan
Information obtained from ClinicalTrials.gov on February 12, 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 (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Primary outcome: TWSTRS Duration Target Score
Secondary outcome: TWSTRS Total ScoreGlobal Assessment of Benefit by Patient Global Assessment of Benefit by Physician Physician Assessment of Cervical Dystonia Severity Physician Comparison of Benefit to Previous Injections Patient Comparison of Benefit to Previous Injections Patient Analog Assessment of Pain Patient Assessment for Retreatment 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
New Delhi, India; Recruiting
Parkville, Victoria, Australia; Not yet recruiting
Additional Information
Starting date: January 2007
Ending date: May 2009
Last updated: September 18, 2008
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