Cervical DystoniaNCT01814774
A Retrospective Chart Review of BOTOX® and Xeomin® for the Treatment of Cervical Dystonia and Blepharospasm
An observational study of Cervical Dystonia and Blepharospasm, run by Allergan at 2 sites in 2 countries.
Trial summary
This study is a retrospective chart review to evaluate the doses of botulinum Type A toxins BOTOX® (onabotulinumtoxinA) and Xeomin® (incobotulinumtoxinA) used for the treatment of Cervical Dystonia and Blepharospasm in clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervical Dystonia, Blepharospasm
- How many people
- 48 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 2013to Jul 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with cervical dystonia or blepharospasm previously treated with Xeomin® and BOTOX®.
Who may be able to join
- confirmed primary diagnosis of idiopathic cervical dystonia or blepharospasm for at least 2 years
- treatment with Xeomin® and BOTOX® for at least 1 year each
Who cannot join
- having a neuromuscular junction transmission disorder or taking any medications that could affect neuromuscular junction transmission
- previous surgical procedure involving bone or muscle for the management of cervical dystonia or blepharospasm
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
This study is a retrospective chart review to evaluate the doses of botulinum Type A toxins BOTOX® (onabotulinumtoxinA) and Xeomin® (incobotulinumtoxinA) used for the treatment of Cervical Dystonia and Blepharospasm in clinical practice.
- Conditions
- Cervical Dystonia, Blepharospasm
- Being tested
- No Intervention
- Medical subject headings
- Torticollis, Blepharospasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
No treatment (intervention) was administered.
| Study group | Role | What they receive |
|---|---|---|
| BOTOX® | Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered. Receives: Other: No Intervention | |
| Xeomin® | Retrospective chart review of doses of Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose of Botulinum Toxin Used to Treat Cervical Dystonia
The average dose of botulinum toxin received per patient per year was calculated.
Measured: 2 Years
Dose of Botulinum Toxin Used to Treat Blepharospasm
The average dose of botulinum toxin received per patient per year was calculated.
Measured: 2 Years
Secondary outcomes (2)
Number of Participants With Adverse Events
An Adverse Event was any unfavorable and unintended sign, symptom, or disease documented in the medical chart that occurred after treatment with botulinum toxin, or pre-existing conditions that worsened during the retrospective period.
Measured: 2 Years
Botulinum Toxin Inter-injection Interval
Injection-interval was the time in weeks between injections of botulinum toxin.
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2013 (estimated)
- Study startJan 2013
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cervical DystoniaStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01814774
- Sponsor's protocol ID
- TRU2011
- Status last verified
- Jun 2014
- First submitted
- 18 Mar 2013
- Last updated
- 3 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Chart Review of BOTOX® and Xeomin® for the Treatment of Cervical Dystonia and Blepharospasm
- ClinicalTrials.gov ID
- NCT01814774
- Acronym / sponsor ID
- TRU2011
- Conditions
- Cervical Dystonia, Blepharospasm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 20 Mar 2013 (estimated)
- Results
- Posted 3 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a retrospective chart review to evaluate the doses of botulinum Type A toxins BOTOX® (onabotulinumtoxinA) and Xeomin® (incobotulinumtoxinA) used for the treatment of Cervical Dystonia and Blepharospasm in clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BOTOX® | – | Other: No InterventionRetrospective chart review of doses of BOTOX® (onabotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered. |
| Xeomin® | – | Other: No InterventionRetrospective chart review of doses of Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with cervical dystonia or blepharospasm previously treated with Xeomin® and BOTOX®.
Key inclusion criteria (2 listed)
- confirmed primary diagnosis of idiopathic cervical dystonia or blepharospasm for at least 2 years
- treatment with Xeomin® and BOTOX® for at least 1 year each
Key exclusion criteria (2 listed)
- having a neuromuscular junction transmission disorder or taking any medications that could affect neuromuscular junction transmission
- previous surgical procedure involving bone or muscle for the management of cervical dystonia or blepharospasm
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 |
|---|---|---|
| No InterventionNo treatment (intervention) was administered. | Other | BOTOX®, Xeomin® |
Primary outcome
Dose of Botulinum Toxin Used to Treat Cervical Dystonia
Time frame: 2 Years
The average dose of botulinum toxin received per patient per year was calculated.
Dose of Botulinum Toxin Used to Treat Blepharospasm
Time frame: 2 Years
The average dose of botulinum toxin received per patient per year was calculated.
2 secondary outcomes
Number of Participants With Adverse Events
Time frame: 2 Years
Botulinum Toxin Inter-injection Interval
Time frame: 2 Years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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An Observational Study of Individuals With Isolated Dystonia
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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.
Medical Director study director
Allergan
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Dystonia and Blepharospasm, run by Allergan at 2 sites in 2 countries.
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 2 inclusion and 2 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 3 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway, United Kingdom. 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?
Yes. Results are posted in the registry (first posted 3 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Dose of Botulinum Toxin Used to Treat Cervical Dystonia (time frame: 2 Years). The study lists 2 primary outcomes in all. 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 3 Jul 2014.