Cervical DystoniaNCT02245958
A Retrospective Chart Review of BOTOX® and Xeomin® for the Management 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
- 44 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Aug 2015to Dec 2015
- 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 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® in clinical practice.
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 2 years 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
Measured: 4 Years
Dose of Botulinum Toxin Used to Treat Blepharospasm
Measured: 4 Years
Secondary outcomes (3)
Botulinum Toxin Inter-injection Intervals
Measured: 4 Years
Number of Participants with Adverse Events
Measured: 4 Years
Annual Botulinum Toxin Dose per Patient
Measured: 4 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2014 (estimated)
- Study startAug 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 44 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
- NCT02245958
- Sponsor's protocol ID
- GMA-US-NEU-0271
- Status last verified
- Jan 2016
- First submitted
- 18 Sep 2014
- Last updated
- 8 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2016. 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 Management of Cervical Dystonia and Blepharospasm
- ClinicalTrials.gov ID
- NCT02245958
- Acronym / sponsor ID
- GMA-US-NEU-0271
- Conditions
- Cervical Dystonia, Blepharospasm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 22 Sep 2014 (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 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® in clinical practice.
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 2 years 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: 4 Years
Dose of Botulinum Toxin Used to Treat Blepharospasm
Time frame: 4 Years
3 secondary outcomes
Botulinum Toxin Inter-injection Intervals
Time frame: 4 Years
Number of Participants with Adverse Events
Time frame: 4 Years
Annual Botulinum Toxin Dose per Patient
Time frame: 4 Years
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 8 Jan 2016.
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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 8 Jan 2016. 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 Mexico, 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?
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?
Dose of Botulinum Toxin Used to Treat Cervical Dystonia (time frame: 4 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 8 Jan 2016.