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

Cervical Dystonia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00836017
• Other study ID #: MedAff BTX-0718
• Status: Completed
• Phase: N/A
• First received: February 2, 2009
• Last updated: June 19, 2014
• Start date: January 2009
• Est. completion date: August 2013

Study information

• Verified date: June 2014
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1046
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cervical Dystonia
• Dystonia
• Dystonic Disorders

Intervention

Other:
• No Intervention
No intervention was administered as part of the study.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	4-6 weeks after treatment 3 (Up to 104.3 weeks)	No
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.	Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks)	No
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.	Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks)	No
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.	Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks)	No
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.	Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks)	No