Cervical Dystonia
Conditions
Brief summary
This study is an observational trial which will measure the efficacy of onabotulinumtoxinA in treating Cervical Dystonia.
Interventions
OTHERNo Intervention
No intervention was administered as part of the study.
Sponsors
Allergan
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Diagnosed with Cervical Dystonia * Candidate for botulinum toxin type A therapy * New to physician's practice, and/or new to botulinum toxin type A therapy, or has not been injected with botulinum toxin type A for at least 16 weeks as a participant in another clinical trial investigating botulinum toxin type A for cervical dystonia * Able to follow study instructions and complete study activities
Exclusion criteria
* Patients undergoing elective surgery during the trial period * Females who are pregnant, nursing, or planning a pregnancy * History of poor cooperation or compliance with medical treatment or unreliability * Any condition or situation in which, in the investigator's opinion, places the patient at significant risk, could confound the study data, or may interfere with the patient's participation in the study, including but not limited to unstable medical conditions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score | 4-6 weeks after treatment 3 (Up to 104.3 weeks) | TWSTRS is an assessment scale used to measure the impact of cervical dystonia on patients. The score is comprised of 3 subscales: Severity, Disability, and Pain, each of which is scored independently. The total of these 3 subscales comprises the TWSTRS total score which is scored from 0 (least symptoms) to 85 (worst symptoms). Higher scores indicate a greater degree of symptom severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Cervical Dystonia (CD) Severity Mild | Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks) | The physician assessed the patient's severity of CD using a 3-point scale: mild, moderate or severe. The percentage of participants with CD Severity Mild is reported. |
| Percentage of Participants With Improvement in Clinicians Global Impression of Change | Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks) | The physician evaluated the change in the patient's present condition compared to Baseline using a 7-point scale where: 1= very much improved to 7= very much worse. The percentage of participants where the physician's response was: 1=very much improved, 2=much improved or 3=minimally improved is reported. |
| Percentage of Participants With Improvement in the Patient Global Impression of Change | Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks) | The patient evaluated the change in their present condition compared to Baseline using a 7-point scale where: 1= very much improved to 7= very much worse. The percentage of participants with responses: 1=very much improved, 2=much improved or 3=minimally improved is reported. |
| Pain Numeric Rating Scale Score | Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks) | Patients rated their level of pain during the past 24 hours using an 11-point scale where: 0=no pain to 10= pain as bad as you can imagine. A lower number score indicated a lower amount of pain. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BOTOX® Patients received BOTOX® (onabotulinumtoxinA) treatment as standard of care in clinical practice as prescribed by the physician. No intervention was administered as part of the study. | 1,041 |
| Total | 1,041 |
Baseline characteristics
| Characteristic | BOTOX® |
|---|---|
| Age, Continuous | 58.0 Years STANDARD_DEVIATION 14.7 |
| Sex: Female, Male Female | 774 Participants |
| Sex: Female, Male Male | 267 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 138 / 1,041 |
| serious Total, serious adverse events | 33 / 1,041 |
Outcome results
Primary
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score
TWSTRS is an assessment scale used to measure the impact of cervical dystonia on patients. The score is comprised of 3 subscales: Severity, Disability, and Pain, each of which is scored independently. The total of these 3 subscales comprises the TWSTRS total score which is scored from 0 (least symptoms) to 85 (worst symptoms). Higher scores indicate a greater degree of symptom severity.
Time frame: 4-6 weeks after treatment 3 (Up to 104.3 weeks)
Population: All participants with data available for this outcome measure at all visits.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BOTOX® | Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score | 27.1 score on a scale | Standard Deviation 14.6 |
Secondary
Pain Numeric Rating Scale Score
Patients rated their level of pain during the past 24 hours using an 11-point scale where: 0=no pain to 10= pain as bad as you can imagine. A lower number score indicated a lower amount of pain.
Time frame: Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks)
Population: Participants with data available for this outcome measure at all visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BOTOX® | Pain Numeric Rating Scale Score | Baseline | 6.2 score on a scale | Standard Deviation 2.2 |
| BOTOX® | Pain Numeric Rating Scale Score | 4-6 weeks after treatment 3 | 4.2 score on a scale | Standard Deviation 2.5 |
Secondary
Percentage of Participants With Cervical Dystonia (CD) Severity Mild
The physician assessed the patient's severity of CD using a 3-point scale: mild, moderate or severe. The percentage of participants with CD Severity Mild is reported.
Time frame: Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks)
Population: All participants with data available for this outcome measure at all visits.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BOTOX® | Percentage of Participants With Cervical Dystonia (CD) Severity Mild | Baseline | 30.5 percentage of participants |
| BOTOX® | Percentage of Participants With Cervical Dystonia (CD) Severity Mild | 4-6 weeks after treatment 3 | 58.5 percentage of participants |
Secondary
Percentage of Participants With Improvement in Clinicians Global Impression of Change
The physician evaluated the change in the patient's present condition compared to Baseline using a 7-point scale where: 1= very much improved to 7= very much worse. The percentage of participants where the physician's response was: 1=very much improved, 2=much improved or 3=minimally improved is reported.
Time frame: Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks)
Population: All participants with data available for this outcome measure at all visits.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BOTOX® | Percentage of Participants With Improvement in Clinicians Global Impression of Change | 95.0 percentage of participants |
Secondary
Percentage of Participants With Improvement in the Patient Global Impression of Change
The patient evaluated the change in their present condition compared to Baseline using a 7-point scale where: 1= very much improved to 7= very much worse. The percentage of participants with responses: 1=very much improved, 2=much improved or 3=minimally improved is reported.
Time frame: Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks)
Population: Participants with data available for this outcome measure at all visits.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BOTOX® | Percentage of Participants With Improvement in the Patient Global Impression of Change | 91.7 percentage of participants |