N/A
Completed N=1,046
CD-PROBE: Cervical Dystonia Patient Registry for the Observation of onabotulinumtoxinA Efficacy
Source: ClinicalTrials.gov NCT00836017 ↗Enrolled (actual)
1,046
Serious AEs
3.2%
Results posted
Jul 2014
Primary outcomePrimary: Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score — 27.1 score on a scale
Summary
This study is an observational trial which will measure the efficacy of onabotulinumtoxinA in treating Cervical Dystonia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score |
27.1 | — |
| SECONDARY Percentage of Participants With Cervical Dystonia (CD) Severity Mild |
30.5; 58.5 | — |
| SECONDARY Percentage of Participants With Improvement in Clinicians Global Impression of Change |
95.0 | — |
| SECONDARY Percentage of Participants With Improvement in the Patient Global Impression of Change |
91.7 | — |
| SECONDARY Pain Numeric Rating Scale Score |
6.2; 4.2 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00836017). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.