TorticollisNCT01655862
A Prospective, Observational Study of Patients With Cervical Dystonia (Dystonie) Treated With OnabotulinumtoxinA
An observational study of Torticollis, run by Allergan at 8 sites in Canada.
Trial summary
This is an observational study to assess health-related quality of life in patients with cervical dystonia (dystonie) treated with OnabotulinumtoxinA per routine clinical practice. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Torticollis
- What is being tested?
- OnabotulinumtoxinA
- Type of treatment
- Injection or infusion
- How many people
- 62 participants
- Where
- 8 sitesCanada
- Study dates
- Jul 2012to Feb 2017
- Phase
- Observational
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with Cervical Dystonia (Dystonie)
Who may be able to join
- Diagnosis of cervical dystonia (dystonie) and able to receive botulinum toxin Type A as deemed medically necessary by the physician
Who cannot join
- Participation in a clinical trial for any botulinum toxin indication
- Planning elective surgery during the observational study period
- Treatment with any botulinum toxin product for cervical dystonia (dystonie)
- Treatment with any botulinum toxin product for a non-cervical dystonia (dystonie) condition within 2 months of study start
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Canada8 sites
Clinique Neuro-Rive Sud
Greenfield Park, Quebec, J4V 2J2
Hôpital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4
Chum-Notre-Dame
Montreal, Quebec, H2L 4M1
Queen Elizabeth Health Centre: Medical Specialist Clinic
Montreal, Quebec, H4A 3L5
CHU de Québec, Hôpital de l'Enfant-Jésus
Québec, Quebec, G1J 1Z4
Centre Medical Le Mesnil
Québec, Quebec, G2K 0H1
Polyclinique Medicale des Ponts
Saint Romuald, Quebec, G6W 8H1
CHU - Sherbrooke
Sherbrooke, Quebec, J1H 5N4
About this study
Official title: Multi-Centre, Prospective, Observational Study of Patient Reported Outcomes in Patients Diagnosed With Cervical Dystonia and Treated With OnabotulinumtoxinA for Injection (BOTOX®) (POSTURe)
This is an observational study to assess health-related quality of life in patients with cervical dystonia (dystonie) treated with OnabotulinumtoxinA per routine clinical practice.
- Conditions
- Torticollis
- Being tested
- OnabotulinumtoxinA
- Medical subject headings
- Torticollis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OnabotulinumtoxinABiological
Also called botulinum toxin Type A, BOTOX®
OnabotulinumtoxinA injections at doses and frequencies as determined by the physician in accordance with clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| OnabotulinumtoxinA | OnabotulinumtoxinA injections at doses and frequencies as determined by the physician in accordance with clinical practice. Receives: Biological: OnabotulinumtoxinA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Cervical Dystonia Impact Profile Questionnaire (CDIP-58) Score
Measured: Baseline, 96 Weeks
Secondary outcomes (4)
Patient's Global Impression of Change (PGIC) Using a 7-Point Scale
Measured: Baseline, 96 Weeks
Work Productivity Assessment Using a 10-Item Questionnaire
Measured: 96 Weeks
Change from Baseline in Hospital Anxiety and Depression Scale (HAD) Score
Measured: Baseline, 96 Weeks
Reasons for Withdrawal of Treatment
Measured: 96 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2012 (estimated)
- Study startJul 2012
- Primary completionFeb 2017
- Study completionFeb 2017
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.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Goran Davidovic, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01655862
- Sponsor's protocol ID
- CMA-BTX-12-001
- Status last verified
- Mar 2017
- First submitted
- 31 Jul 2012
- Last updated
- 30 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Centre, Prospective, Observational Study of Patient Reported Outcomes in Patients Diagnosed With Cervical Dystonia and Treated With OnabotulinumtoxinA for Injection (BOTOX®) (POSTURe)
- ClinicalTrials.gov ID
- NCT01655862
- Acronym / sponsor ID
- CMA-BTX-12-001
- Conditions
- Torticollis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 2 Aug 2012 (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.
This is an observational study to assess health-related quality of life in patients with cervical dystonia (dystonie) treated with OnabotulinumtoxinA per routine clinical practice.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OnabotulinumtoxinA | – | Biological: OnabotulinumtoxinAOnabotulinumtoxinA injections at doses and frequencies as determined by the physician in accordance with clinical practice. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Cervical Dystonia (Dystonie)
Key inclusion criteria (1 listed)
- Diagnosis of cervical dystonia (dystonie) and able to receive botulinum toxin Type A as deemed medically necessary by the physician
Key exclusion criteria (4 listed)
- Participation in a clinical trial for any botulinum toxin indication
- Planning elective surgery during the observational study period
- Treatment with any botulinum toxin product for cervical dystonia (dystonie)
- Treatment with any botulinum toxin product for a non-cervical dystonia (dystonie) condition within 2 months of study start
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 |
|---|---|---|
| OnabotulinumtoxinAAlso: botulinum toxin Type A, BOTOX®OnabotulinumtoxinA injections at doses and frequencies as determined by the physician in accordance with clinical practice. | Biological | OnabotulinumtoxinA |
Primary outcome
Change from Baseline in Cervical Dystonia Impact Profile Questionnaire (CDIP-58) Score
Time frame: Baseline, 96 Weeks
4 secondary outcomes
Patient's Global Impression of Change (PGIC) Using a 7-Point Scale
Time frame: Baseline, 96 Weeks
Work Productivity Assessment Using a 10-Item Questionnaire
Time frame: 96 Weeks
Change from Baseline in Hospital Anxiety and Depression Scale (HAD) Score
Time frame: Baseline, 96 Weeks
Reasons for Withdrawal of Treatment
Time frame: 96 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2017.
Related trials for Torticollis
RecruitingPhase 2
A Study to Evaluate the Efficacy, Safety, and Tolerability of VIM0423 in Individuals With Isolated Dystonia
Dystonia
Not yet recruitingObservational study
Assessment of Cervical Range of Motion Restrictions in Infants With Arthrogenic Torticollis - A Feasibility Study
Torticollis (Arthrogenic)
Recruiting
Effect of Vibro-tactile Stimulation Intensity on Head Posture in Cervical Dystonia
Cervical Dystonia
Active, not recruitingObservational study
An Observational Study of Individuals With Isolated Dystonia
Isolated/Primary Dystonia That Affects More Than One Region of the Body
Recruiting
Noninvasive Brain Stimulation for Cervical Dystonia
Cervical Dystonia
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.
Goran Davidovic study director
Allergan
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Torticollis, run by Allergan at 8 sites 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 1 inclusion and 4 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: finished, as of the sponsor's last update on 30 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from Baseline in Cervical Dystonia Impact Profile Questionnaire (CDIP-58) Score (time frame: Baseline, 96 Weeks). 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 30 Mar 2017.