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

Completed

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

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
BOTOX®	No Intervention	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.