Clinical trial NCT00836017: CD-PROBE: Cervical Dystonia Patient Registry for the Observation of onabotulinumtoxinA Efficacy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Dystonia
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2009-02-04
Enrollment: 1046
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Cervical Dystonia whom are being treated with onabotulinumtoxinA

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


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

Primary outcomes:
measure: Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score
timeFrame: 4-6 weeks after treatment 3 (Up to 104.3 weeks)
Secondary outcomes:
measure: Percentage of Participants With Cervical Dystonia (CD) Severity Mild
timeFrame: Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks)
measure: Percentage of Participants With Improvement in Clinicians Global Impression of Change
timeFrame: Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks)
measure: Percentage of Participants With Improvement in the Patient Global Impression of Change
timeFrame: Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks)
measure: Pain Numeric Rating Scale Score
timeFrame: Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks)
Other outcomes:
Locations:
city: Springfield
country: United States
state: Massachusetts
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Agarwal P, Barbano R, Moore H, Schwartz M, Zuzek A, Sadeghi M, Patel A. OnabotulinumtoxinA Dosing, Disease Severity, and Treatment Benefit in Patients With Cervical Dystonia: A Cohort Analysis From CD PROBE. Front Neurol. 2022 Jun 30;13:914486. doi: 10.3389/fneur.2022.914486. eCollection 2022.
citation: Molho ES, Stacy M, Gillard P, Charles D, Adler CH, Jankovic J, Schwartz M, Brin MF. Impact of Cervical Dystonia on Work Productivity: An Analysis From a Patient Registry. Mov Disord Clin Pract. 2016 Mar-Apr;3(2):130-138. doi: 10.1002/mdc3.12238. Epub 2015 Dec 16.
citation: Jankovic J, Adler CH, Charles D, Comella C, Stacy M, Schwartz M, Manack Adams A, Brin MF. Primary results from the cervical dystonia patient registry for observation of onabotulinumtoxina efficacy (CD PROBE). J Neurol Sci. 2015 Feb 15;349(1-2):84-93. doi: 10.1016/j.jns.2014.12.030. Epub 2014 Dec 27.
citation: Jankovic J, Adler CH, Charles PD, Comella C, Stacy M, Schwartz M, Sutch SM, Brin MF, Papapetropoulos S. Rationale and design of a prospective study: Cervical Dystonia Patient Registry for Observation of OnaBotulinumtoxinA Efficacy (CD PROBE). BMC Neurol. 2011 Nov 4;11:140. doi: 10.1186/1471-2377-11-140.