TorticollisPhase 1NCT00175604
Comparative Trial of Botox in the Management of Children With Congenital Muscular Torticollis
A Phase 1 study testing Botox in people with Torticollis, run by University of British Columbia at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 4 months to 1 year
- Conditions the study is for
- Torticollis
- What is being tested?
- Botox
- Type of treatment
- Injection or infusion
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2004to Feb 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 months to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
British Columbia Children's Hospital, Dept. of Orthopedics
Vancouver, British Columbia, V6H 3V4
About this study
Official title: Comparative Trial of Botox Versus Conventional Treatment Used in the Management of Children With Congenital Muscular Torticollis (CMT)
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.
Read the 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.
- Conditions
- Torticollis
- Being tested
- Botox
- Keywords
- Botox, torticollis, Congenital Muscular Torticollis (CMT)
- Medical subject headings
- Torticollis, Congenital torticollis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BotoxDrug
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome will be range of motion.
Measured: assessed bi-weekly until treatment is complete
Secondary outcomes (1)
The secondary outcomes will be length of treatment time and number of required surgeries.
Measured: assessed bi-weekly until treatment is complete
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startAug 2004
- Primary completionFeb 2008 (estimated)
- Study completionFeb 2008 (estimated)
Why it stopped: Not able to recruit any subjects for the study and was closed in February 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TorticollisStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Investigators
- Stephen Tredwell, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00175604
- Sponsor's protocol ID
- C03-0550
- Other IDs
- W03-0164
- Status last verified
- Feb 2011
- First submitted
- 13 Sep 2005
- Last updated
- 6 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Trial of Botox Versus Conventional Treatment Used in the Management of Children With Congenital Muscular Torticollis (CMT)
- ClinicalTrials.gov ID
- NCT00175604
- Acronym / sponsor ID
- C03-0550
- Conditions
- Torticollis
- Keywords
- Botox, torticollis, Congenital Muscular Torticollis (CMT)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not able to recruit any subjects for the study and was closed in February 2008
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Aug 2004
- Primary completion
- Feb 2008 (estimated)
- Study completion
- Feb 2008 (estimated)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 4 months to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BotoxThe 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. | Drug | – |
Primary outcome
The primary outcome will be range of motion.
Time frame: assessed bi-weekly until treatment is complete
1 secondary outcome
The secondary outcomes will be length of treatment time and number of required surgeries.
Time frame: assessed bi-weekly until treatment is complete
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Tredwell, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Botox in people with Torticollis, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome will be range of motion. (time frame: assessed bi-weekly until treatment is complete). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2015; AzTrials last refreshed its copy on 8 Nov 2026.