CD-PROBE: Cervical Dystonia Patient Registry for the Observation of onabotulinumtoxinA Efficacy

Study Overview
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Brief Summary
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This study is an observational trial which will measure the efficacy of onabotulinumtoxinA in treating Cervical Dystonia.

Conditions
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Cervical Dystonia

Intervention / Treatment
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* Other: No Intervention


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BOTOX®<br>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. | Other: No Intervention<br>* No intervention was administered as part of the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 4-6 weeks after treatment 3 (Up to 104.3 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks) | 
| 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. | Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks) | 
| 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. | Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks) | 
| 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. | Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks) |