An observational study in Cervical Dystonia and Blepharospasm, sponsored by Allergan. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-07-03.
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.
121 studies on the registry are indexed under Torticollis; 18 are open to participants now.
This study's enrollment of 48 is close to the median of 48 across 43 observational studies indexed under Torticollis.
Browse Torticollis studies →Allergan is the lead sponsor of 505 studies on the registry; none are open to participants now.
Of its 93 completed or terminated interventional studies of FDA-regulated products, 91 (98%) have results posted.
First submitted before Allergan became part of AbbVie.
Counted across the registry records on this site, refreshed daily.
Participants with cervical dystonia or blepharospasm previously treated with Xeomin® and BOTOX®.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
Other: No Intervention
Retrospective chart review of doses of Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
Other: No Intervention
No treatment (intervention) was administered.
Dose of Botulinum Toxin Used to Treat Cervical Dystonia
The average dose of botulinum toxin received per patient per year was calculated.
Time frame: 2 Years
Dose of Botulinum Toxin Used to Treat Blepharospasm
The average dose of botulinum toxin received per patient per year was calculated.
Time frame: 2 Years
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.
Time frame: 2 Years
Botulinum Toxin Inter-injection Interval
Injection-interval was the time in weeks between injections of botulinum toxin.
Time frame: 2 Years
| Milestone | All Participants |
|---|---|
| Started | 48 |
| Completed | 48 |
| Not completed | 0 |
The average dose of botulinum toxin received per patient per year was calculated.
| units per patient per year | BOTOX® | Xeomin® |
|---|---|---|
| Dose of Botulinum Toxin Used to Treat Cervical Dystonia | 444.70 (347.16 to 542.24) | 536.30 (409.64 to 662.96) |
The average dose of botulinum toxin received per patient per year was calculated.
| units per patient per year | BOTOX® | Xeomin® |
|---|---|---|
| Dose of Botulinum Toxin Used to Treat Blepharospasm | 50.40 (21.21 to 79.59) | 64.01 (33.32 to 94.70) |
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.
| participants | BOTOX® | Xeomin® |
|---|---|---|
| Number of Participants With Adverse Events | 12 | 10 |
Injection-interval was the time in weeks between injections of botulinum toxin.
| weeks | BOTOX® | Xeomin® |
|---|---|---|
| Botulinum Toxin Inter-injection Interval | 15.83 ± 4.02 | 14.39 ± 3.38 |
Collected over 2 Years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| BOTOX® | — | 0/48 (0%) | 7/48 (14.6%) |
| Xeomin® | — | 0/48 (0%) | 4/48 (8.3%) |
| Event | BOTOX® | Xeomin® |
|---|---|---|
| DysphagiaGastrointestinal disorders | 4/48 | 1/48 |
| PtosisEye disorders | 3/48 | 3/48 |
| Age, Continuous(years) | All Participants |
|---|---|
| Mean | 64.1 ± 12.37 |
| Sex: Female, Male(Participants) | All Participants |
|---|---|
| Female | 35 |
| Male | 13 |
The record gives a start of Jan 2013, a primary completion of Jul 2013 and a completion of Jul 2013. It does not say whether these dates are actual or estimated.
Results were first posted in Jul 2014, 1 year after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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