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Sponsored by: |
University of British Columbia |
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Information provided by: | University of British Columbia |
ClinicalTrials.gov Identifier: | NCT00175604 |
The primary purpose is to investigate the effect of Botox on the treatment of congenital muscular torticollis (CMT). The investigators' hypothesis is that a Botox injection will be an effective treatment when used in conjunction with current treatment procedures.
Condition | Intervention | Phase |
---|---|---|
Torticollis |
Drug: Botox |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Comparative Trial of Botox Versus Conventional Treatment Used in the Management of Children With Congenital Muscular Torticollis (CMT) |
Estimated Enrollment: | 20 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
The babies that require a neck collar for CMT will be randomly placed into two groups. One group will receive standard treatment which includes physiotherapy and occupational therapy. The other group will receive standard treatment plus an injection of Botox. The babies will be monitored to determine if one group has a more favorable outcome than the other in terms of range of motion, length of treatment time and number of required surgeries.
Ages Eligible for Study: | 4 Months to 1 Year |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Angie Perdios | 604-875-2359 | aperdios@cw.bc.ca |
Canada, British Columbia | |
British Columbia Children's Hospital, Dept. of Orthopedics | |
Vancouver, British Columbia, Canada, V6H 3V4 |
Principal Investigator: | Stephen Tredwell, MD | University of British Columbia |
Responsible Party: | University of British Columbia ( Dr. Stephen Tredwell ) |
Study ID Numbers: | C03-0550, W03-0164 |
Study First Received: | September 13, 2005 |
Last Updated: | August 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00175604 |
Health Authority: | Canada: Health Canada |
Botox torticollis Congenital Muscular Torticollis (CMT) |
Dystonic Disorders Signs and Symptoms Torticollis Botulinum Toxins Movement Disorders Neurologic Manifestations |
Central Nervous System Diseases Dystonia Botulinum Toxin Type A Dyskinesias Congenital torticollis |
Physiological Effects of Drugs Nervous System Diseases Neuromuscular Agents Peripheral Nervous System Agents Pharmacologic Actions |