Trial Outcomes & Findings for CD-PROBE: Cervical Dystonia Patient Registry for the Observation of onabotulinumtoxinA Efficacy (NCT NCT00836017)
NCT ID: NCT00836017
Last Updated: 2014-07-17
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
1046 participants
Primary outcome timeframe
4-6 weeks after treatment 3 (Up to 104.3 weeks)
Results posted on
2014-07-17
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
1046
|
|
Overall Study
COMPLETED
|
502
|
|
Overall Study
NOT COMPLETED
|
544
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CD-PROBE: Cervical Dystonia Patient Registry for the Observation of onabotulinumtoxinA Efficacy
Baseline characteristics by cohort
| Measure |
BOTOX®
n=1041 Participants
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.
|
|---|---|
|
Age, Continuous
|
58.0 Years
STANDARD_DEVIATION 14.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
774 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
267 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4-6 weeks after treatment 3 (Up to 104.3 weeks)Population: All participants with data available for this outcome measure at all visits.
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.
Outcome measures
| Measure |
BOTOX®
n=479 Participants
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.
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|---|---|
|
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score
|
27.1 score on a scale
Standard Deviation 14.6
|
SECONDARY outcome
Timeframe: Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks)Population: All participants with data available for this outcome measure at all visits.
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.
Outcome measures
| Measure |
BOTOX®
n=475 Participants
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.
|
|---|---|
|
Percentage of Participants With Cervical Dystonia (CD) Severity Mild
4-6 weeks after treatment 3
|
58.5 percentage of participants
|
|
Percentage of Participants With Cervical Dystonia (CD) Severity Mild
Baseline
|
30.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks)Population: All participants with data available for this outcome measure at all visits.
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.
Outcome measures
| Measure |
BOTOX®
n=479 Participants
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.
|
|---|---|
|
Percentage of Participants With Improvement in Clinicians Global Impression of Change
|
95.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks)Population: Participants with data available for this outcome measure at all visits.
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.
Outcome measures
| Measure |
BOTOX®
n=470 Participants
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.
|
|---|---|
|
Percentage of Participants With Improvement in the Patient Global Impression of Change
|
91.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks)Population: Participants with data available for this outcome measure at all visits.
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.
Outcome measures
| Measure |
BOTOX®
n=286 Participants
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.
|
|---|---|
|
Pain Numeric Rating Scale Score
Baseline
|
6.2 score on a scale
Standard Deviation 2.2
|
|
Pain Numeric Rating Scale Score
4-6 weeks after treatment 3
|
4.2 score on a scale
Standard Deviation 2.5
|
Adverse Events
BOTOX®
Serious events: 33 serious events
Other events: 138 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BOTOX®
n=1041 participants at risk
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.
|
|---|---|
|
Cardiac disorders
Cardiac arrest
|
0.29%
3/1041
The number of participants at risk for Serious Adverse Events and Adverse Events was based on all enrolled participants who received treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
0.19%
2/1041
The number of participants at risk for Serious Adverse Events and Adverse Events was based on all enrolled participants who received treatment.
|
|
Gastrointestinal disorders
Gastritis
|
0.10%
1/1041
The number of participants at risk for Serious Adverse Events and Adverse Events was based on all enrolled participants who received treatment.
|
|
Gastrointestinal disorders
Intestinal mass
|
0.10%
1/1041
The number of participants at risk for Serious Adverse Events and Adverse Events was based on all enrolled participants who received treatment.
|
|
General disorders
Chest pain
|
0.19%
2/1041
The number of participants at risk for Serious Adverse Events and Adverse Events was based on all enrolled participants who received treatment.
|
|
General disorders
Pyrexia
|
0.19%
2/1041
The number of participants at risk for Serious Adverse Events and Adverse Events was based on all enrolled participants who received treatment.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.10%
1/1041
The number of participants at risk for Serious Adverse Events and Adverse Events was based on all enrolled participants who received treatment.
|
|
Infections and infestations
Cellulitis
|
0.10%
1/1041
The number of participants at risk for Serious Adverse Events and Adverse Events was based on all enrolled participants who received treatment.
|
|
Infections and infestations
Pneumonia
|
0.10%
1/1041
The number of participants at risk for Serious Adverse Events and Adverse Events was based on all enrolled participants who received treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.19%
2/1041
The number of participants at risk for Serious Adverse Events and Adverse Events was based on all enrolled participants who received treatment.
|
|
Infections and infestations
Urosepsis
|
0.10%
1/1041
The number of participants at risk for Serious Adverse Events and Adverse Events was based on all enrolled participants who received treatment.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.10%
1/1041
The number of participants at risk for Serious Adverse Events and Adverse Events was based on all enrolled participants who received treatment.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.10%
1/1041
The number of participants at risk for Serious Adverse Events and Adverse Events was based on all enrolled participants who received treatment.
|
|
Injury, poisoning and procedural complications
Endotracheal intubation complication
|
0.10%
1/1041
The number of participants at risk for Serious Adverse Events and Adverse Events was based on all enrolled participants who received treatment.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.19%
2/1041
The number of participants at risk for Serious Adverse Events and Adverse Events was based on all enrolled participants who received treatment.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.10%
1/1041
The number of participants at risk for Serious Adverse Events and Adverse Events was based on all enrolled participants who received treatment.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.10%
1/1041
The number of participants at risk for Serious Adverse Events and Adverse Events was based on all enrolled participants who received treatment.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.10%
1/1041
The number of participants at risk for Serious Adverse Events and Adverse Events was based on all enrolled participants who received treatment.
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
0.10%
1/1041
The number of participants at risk for Serious Adverse Events and Adverse Events was based on all enrolled participants who received treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.10%
1/1041
The number of participants at risk for Serious Adverse Events and Adverse Events was based on all enrolled participants who received treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Polycythaemia vera
|
0.10%
1/1041
The number of participants at risk for Serious Adverse Events and Adverse Events was based on all enrolled participants who received treatment.
|
|
Nervous system disorders
Convulsion
|
0.19%
2/1041
The number of participants at risk for Serious Adverse Events and Adverse Events was based on all enrolled participants who received treatment.
|
|
Nervous system disorders
Loss of consciousness
|
0.19%
2/1041
The number of participants at risk for Serious Adverse Events and Adverse Events was based on all enrolled participants who received treatment.
|
|
Nervous system disorders
Migraine
|
0.10%
1/1041
The number of participants at risk for Serious Adverse Events and Adverse Events was based on all enrolled participants who received treatment.
|
|
Nervous system disorders
Syncope
|
0.19%
2/1041
The number of participants at risk for Serious Adverse Events and Adverse Events was based on all enrolled participants who received treatment.
|
|
Psychiatric disorders
Mental disorder
|
0.10%
1/1041
The number of participants at risk for Serious Adverse Events and Adverse Events was based on all enrolled participants who received treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.10%
1/1041
The number of participants at risk for Serious Adverse Events and Adverse Events was based on all enrolled participants who received treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.10%
1/1041
The number of participants at risk for Serious Adverse Events and Adverse Events was based on all enrolled participants who received treatment.
|
|
Surgical and medical procedures
Alcohol detoxification
|
0.10%
1/1041
The number of participants at risk for Serious Adverse Events and Adverse Events was based on all enrolled participants who received treatment.
|
|
Surgical and medical procedures
Cardiac operation
|
0.10%
1/1041
The number of participants at risk for Serious Adverse Events and Adverse Events was based on all enrolled participants who received treatment.
|
|
Surgical and medical procedures
Tracheostomy tube removal
|
0.10%
1/1041
The number of participants at risk for Serious Adverse Events and Adverse Events was based on all enrolled participants who received treatment.
|
|
Vascular disorders
Deep vein thrombosis
|
0.10%
1/1041
The number of participants at risk for Serious Adverse Events and Adverse Events was based on all enrolled participants who received treatment.
|
|
Vascular disorders
Orthostatic hypotension
|
0.19%
2/1041
The number of participants at risk for Serious Adverse Events and Adverse Events was based on all enrolled participants who received treatment.
|
Other adverse events
| Measure |
BOTOX®
n=1041 participants at risk
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.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
7.0%
73/1041
The number of participants at risk for Serious Adverse Events and Adverse Events was based on all enrolled participants who received treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
6.2%
65/1041
The number of participants at risk for Serious Adverse Events and Adverse Events was based on all enrolled participants who received treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER