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

NCT ID: NCT00836017

Last Updated: 2014-07-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1046 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Study Completion Date

2013-08-31

Brief Summary

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

Detailed Description

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Conditions

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Cervical Dystonia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No Intervention

Intervention Type OTHER

No intervention was administered as part of the study.

Interventions

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No Intervention

No intervention was administered as part of the study.

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

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Springfield, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 35847221 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27774495 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25595221 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22054223 (View on PubMed)

Other Identifiers

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MedAff BTX-0718

Identifier Type: -

Identifier Source: org_study_id

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