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

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ClinicalTrials.gov Identifier: NCT00836017
Recruitment Status : Completed
First Posted : February 4, 2009
Results First Posted : July 17, 2014
Last Update Posted : July 17, 2014
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Condition Cervical Dystonia
Intervention Other: No Intervention
Enrollment 1046
Recruitment Details  
Pre-assignment Details  
Arm/Group Title BOTOX®
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 1046
Completed 502
Not Completed 544
Arm/Group Title BOTOX®
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 1041
Hide Baseline Analysis Population Description
Baseline measures were based on all enrolled participants who received treatment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1041 participants
58.0  (14.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1041 participants
Female
774
  74.4%
Male
267
  25.6%
1.Primary Outcome
Title Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score
Hide Description 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.
Time Frame 4-6 weeks after treatment 3 (Up to 104.3 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with data available for this outcome measure at all visits.
Arm/Group Title BOTOX®
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 479
Mean (Standard Deviation)
Unit of Measure: score on a scale
27.1  (14.6)
2.Secondary Outcome
Title Percentage of Participants With Cervical Dystonia (CD) Severity Mild
Hide Description 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.
Time Frame Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with data available for this outcome measure at all visits.
Arm/Group Title BOTOX®
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 475
Measure Type: Number
Unit of Measure: percentage of participants
Baseline 30.5
4-6 weeks after treatment 3 58.5
3.Secondary Outcome
Title Percentage of Participants With Improvement in Clinicians Global Impression of Change
Hide Description 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.
Time Frame Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with data available for this outcome measure at all visits.
Arm/Group Title BOTOX®
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 479
Measure Type: Number
Unit of Measure: percentage of participants
95.0
4.Secondary Outcome
Title Percentage of Participants With Improvement in the Patient Global Impression of Change
Hide Description 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.
Time Frame Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with data available for this outcome measure at all visits.
Arm/Group Title BOTOX®
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 470
Measure Type: Number
Unit of Measure: percentage of participants
91.7
5.Secondary Outcome
Title Pain Numeric Rating Scale Score
Hide Description 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.
Time Frame Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with data available for this outcome measure at all visits.
Arm/Group Title BOTOX®
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 286
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 6.2  (2.2)
4-6 weeks after treatment 3 4.2  (2.5)
Time Frame [Not Specified]
Adverse Event Reporting Description The number of participants at risk for Serious Adverse Events and Adverse Events was based on all enrolled participants who received treatment.
 
Arm/Group Title BOTOX®
Hide Arm/Group Description 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.
All-Cause Mortality
BOTOX®
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
BOTOX®
Affected / at Risk (%)
Total   33/1041 (3.17%) 
Cardiac disorders   
Cardiac arrest  1  3/1041 (0.29%) 
Gastrointestinal disorders   
Dysphagia * 1  2/1041 (0.19%) 
Gastritis  1  1/1041 (0.10%) 
Intestinal mass  1  1/1041 (0.10%) 
General disorders   
Chest pain * 1  2/1041 (0.19%) 
Pyrexia  1  2/1041 (0.19%) 
Hepatobiliary disorders   
Bile duct stone  1  1/1041 (0.10%) 
Infections and infestations   
Cellulitis  1  1/1041 (0.10%) 
Pneumonia  1  1/1041 (0.10%) 
Urinary tract infection  1  2/1041 (0.19%) 
Urosepsis  1  1/1041 (0.10%) 
Clostridium difficile colitis  1  1/1041 (0.10%) 
Injury, poisoning and procedural complications   
Cervical vertebral fracture  1  1/1041 (0.10%) 
Endotracheal intubation complication  1  1/1041 (0.10%) 
Hip fracture  1  2/1041 (0.19%) 
Overdose  1  1/1041 (0.10%) 
Skin laceration * 1  1/1041 (0.10%) 
Musculoskeletal and connective tissue disorders   
Synovial cyst  1  1/1041 (0.10%) 
Torticollis  1  1/1041 (0.10%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Breast cancer  1  1/1041 (0.10%) 
Polycythaemia vera  1  1/1041 (0.10%) 
Nervous system disorders   
Convulsion  1  2/1041 (0.19%) 
Loss of consciousness * 1  2/1041 (0.19%) 
Migraine * 1  1/1041 (0.10%) 
Syncope * 1  2/1041 (0.19%) 
Psychiatric disorders   
Mental disorder  1  1/1041 (0.10%) 
Respiratory, thoracic and mediastinal disorders   
Respiratory distress * 1  1/1041 (0.10%) 
Respiratory failure  1  1/1041 (0.10%) 
Surgical and medical procedures   
Alcohol detoxification  1  1/1041 (0.10%) 
Cardiac operation  1  1/1041 (0.10%) 
Tracheostomy tube removal  1  1/1041 (0.10%) 
Vascular disorders   
Deep vein thrombosis  1  1/1041 (0.10%) 
Orthostatic hypotension  1  2/1041 (0.19%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
BOTOX®
Affected / at Risk (%)
Total   138/1041 (13.26%) 
Gastrointestinal disorders   
Dysphagia * 1  65/1041 (6.24%) 
Musculoskeletal and connective tissue disorders   
Muscular Weakness * 1  73/1041 (7.01%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Name/Title: Vice President Medical Affairs,
Organization: Allergan, Inc
Phone: 714-246-4500
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00836017     History of Changes
Other Study ID Numbers: MedAff BTX-0718
First Submitted: February 2, 2009
First Posted: February 4, 2009
Results First Submitted: June 19, 2014
Results First Posted: July 17, 2014
Last Update Posted: July 17, 2014