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

NCT00836017 | Completed Results

• 1 other identifier: MedAff BTX-0718
• Study Type: observational
• Target: 1,046
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cervical Dystonia

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (4)

• Percentage of Participants With Cervical Dystonia (CD) Severity Mild

  Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks)

• Percentage of Participants With Improvement in Clinicians Global Impression of Change

  Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks)

• Percentage of Participants With Improvement in the Patient Global Impression of Change

  Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks)

• Pain Numeric Rating Scale Score

  Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks)

Study Arms (1)

BOTOX®

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.

Other: No Intervention

Interventions

No Intervention OTHER

No intervention was administered as part of the study.

BOTOX®

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Cervical Dystonia whom are being treated with onabotulinumtoxinA

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

Springfield, Massachusetts, United States

Location

Related Publications (4)

• 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.

  PMID: 35847221 DERIVED

• 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.

  PMID: 27774495 DERIVED

• 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.

  PMID: 25595221 DERIVED

• 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.

  PMID: 22054223 DERIVED

MeSH Terms

Conditions

Torticollis

Condition Hierarchy (Ancestors)

Dystonia; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Vice President Medical Affairs,
• Organization: Allergan, Inc

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2009
• First Posted: February 4, 2009
• Study Start: January 1, 2009
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: July 17, 2014
• Results First Posted: July 17, 2014

Record last verified: 2014-06

Locations

US (1)