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

Allergan1,046 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

1,046

Conditions

Cervical Dystonia

Interventions

No InterventionOTHER

No intervention was administered as part of the study.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Springfield, Massachusetts, United States

Outcomes

Primary Outcomes

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)

Secondary Outcomes

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)

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)

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)

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.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.