Comparative Trial of Botox in the Management of Children With Congenital Muscular Torticollis - Full Text View

Sponsor:	University of British Columbia
Information provided by:	University of British Columbia
ClinicalTrials.gov Identifier:	NCT00175604

Purpose

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:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Comparative Trial of Botox Versus Conventional Treatment Used in the Management of Children With Congenital Muscular Torticollis (CMT)

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset primary dystonia familial paroxysmal nonkinesigenic dyskinesia

MedlinePlus related topics: Botox

Drug Information available for: Botulinum toxin A

U.S. FDA Resources

Further study details as provided by University of British Columbia:

Primary Outcome Measures:

The primary outcome will be range of motion. [ Time Frame: assessed bi-weekly until treatment is complete ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The secondary outcomes will be length of treatment time and number of required surgeries. [ Time Frame: assessed bi-weekly until treatment is complete ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	August 2004
Estimated Study Completion Date:	February 2008
Estimated Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Intervention Details:

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.

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	4 Months to 1 Year
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Infants diagnosed with CMT and referred by family physician, pediatrician or orthopaedic surgeon
Initial assessment and initiation of treatment prior to 4 months of age
Cervical spine radiograph, no focal bony abnormality
Head tilt greater than 5 degrees at 5 months of age
Lateral head righting past neutral in upright suspension
Restricted neck range of movement in lateral flexion or rotation or both
Signed consent form and willingness to participate in the study
Compliance with attending bi-weekly follow-up appointments

Exclusion Criteria:

Any other diagnosis affecting tone or muscle function
Any condition that would preclude an anesthetic
Any vertebral abnormalities identified by radiograph
Attending other health practitioners for treatment, i.e., massage therapist, chiropractor
Any associated ocular problems as determined by a pediatric ophthalmologist

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00175604

Locations

Canada, British Columbia
British Columbia Children's Hospital, Dept. of Orthopedics
Vancouver, British Columbia, Canada, V6H 3V4

Sponsors and Collaborators

University of British Columbia

Investigators

Principal Investigator:

Stephen Tredwell, MD

University of British Columbia

More Information

No publications provided

Responsible Party:	Dr. Stephen Tredwell, University of British Columbia
ClinicalTrials.gov Identifier:	NCT00175604 History of Changes
Other Study ID Numbers:	C03-0550, W03-0164
Study First Received:	September 13, 2005
Last Updated:	February 18, 2011
Health Authority:	Canada: Health Canada

Keywords provided by University of British Columbia:

Botox
torticollis
Congenital Muscular Torticollis (CMT)

Additional relevant MeSH terms:

Torticollis
Dystonic Disorders
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Dystonia
Dyskinesias

Neurologic Manifestations
Signs and Symptoms
Botulinum Toxins, Type A
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012