Blepharospasm, Cervical Dystonia
Conditions
Brief 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.
Interventions
OTHERNo Intervention
No treatment (intervention) was administered.
Sponsors
Allergan
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose of Botulinum Toxin Used to Treat Cervical Dystonia | 2 Years | The average dose of botulinum toxin received per patient per year was calculated. |
| Dose of Botulinum Toxin Used to Treat Blepharospasm | 2 Years | The average dose of botulinum toxin received per patient per year was calculated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | 2 Years | 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. |
| Botulinum Toxin Inter-injection Interval | 2 Years | Injection-interval was the time in weeks between injections of botulinum toxin. |
Countries
Norway, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) and Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered. | 48 |
| Total | 48 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 64.1 years STANDARD_DEVIATION 12.37 |
| Sex: Female, Male Female | 35 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 7 / 48 | 4 / 48 |
| serious Total, serious adverse events | 0 / 48 | 0 / 48 |
Outcome results
Primary
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
Population: Participants diagnosed with Blepharospasm who received onabotulinumtoxinA for 2 years and incobotulinumtoxinA for 2 years.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| BOTOX® | Dose of Botulinum Toxin Used to Treat Blepharospasm | 50.40 units per patient per year |
| Xeomin® | Dose of Botulinum Toxin Used to Treat Blepharospasm | 64.01 units per patient per year |
Primary
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
Population: Participants diagnosed with Cervical Dystonia who received onabotulinumtoxinA for 2 years and incobotulinumtoxinA for 2 years.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| BOTOX® | Dose of Botulinum Toxin Used to Treat Cervical Dystonia | 444.70 units per patient per year |
| Xeomin® | Dose of Botulinum Toxin Used to Treat Cervical Dystonia | 536.30 units per patient per year |
Secondary
Botulinum Toxin Inter-injection Interval
Injection-interval was the time in weeks between injections of botulinum toxin.
Time frame: 2 Years
Population: All participants who received onabotulinumtoxinA for 2 years and incobotulinumtoxinA for 2 years.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BOTOX® | Botulinum Toxin Inter-injection Interval | 15.83 weeks | Standard Deviation 4.02 |
| Xeomin® | Botulinum Toxin Inter-injection Interval | 14.39 weeks | Standard Deviation 3.38 |
Secondary
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
Population: Safety population included all participants who received at least one dose of botulinum toxin.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BOTOX® | Number of Participants With Adverse Events | 12 participants |
| Xeomin® | Number of Participants With Adverse Events | 10 participants |