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This study is an observational trial which will measure the efficacy of onabotulinumtoxinA in treating Cervical Dystonia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention | Other | No intervention was administered as part of the study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Cervical Dystonia (CD) Severity Mild | 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. | Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks) |
| Percentage of Participants With Improvement in Clinicians Global Impression of Change |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with Cervical Dystonia whom are being treated with onabotulinumtoxinA
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Springfield | Massachusetts | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35847221 | Derived | 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. | |
| 27774495 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Baseline measures were based on all enrolled participants who received treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All participants with data available for this outcome measure at all visits. | Posted | Mean | Standard Deviation | score on a scale | 4-6 weeks after treatment 3 (Up to 104.3 weeks) |
|
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The number of participants at risk for Serious Adverse Events and Adverse Events was based on all enrolled participants who received treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President Medical Affairs, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
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| ID | Term |
|---|---|
| D014103 | Torticollis |
| ID | Term |
|---|---|
| D004421 | Dystonia |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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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. |
| Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks) |
| Percentage of Participants With Improvement in the Patient Global Impression of Change | 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. | Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks) |
| Pain Numeric Rating Scale Score | 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. | Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks) |
| 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. |
| 25595221 | 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. |
| 22054223 | 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. |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Percentage of Participants With Cervical Dystonia (CD) Severity Mild | 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. | All participants with data available for this outcome measure at all visits. | Posted | Number | percentage of participants | Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks) |
|
|
|
| Secondary | Percentage of Participants With Improvement in Clinicians Global Impression of Change | 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. | All participants with data available for this outcome measure at all visits. | Posted | Number | percentage of participants | Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks) |
|
|
|
| Secondary | Percentage of Participants With Improvement in the Patient Global Impression of Change | 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. | Participants with data available for this outcome measure at all visits. | Posted | Number | percentage of participants | Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks) |
|
|
|
| Secondary | Pain Numeric Rating Scale Score | 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. | Participants with data available for this outcome measure at all visits. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks) |
|
|
|
| 33 |
| 1,041 |
| 138 |
| 1,041 |
| Dysphagia | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Intestinal mass | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Bile duct stone | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Clostridium difficile colitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| Endotracheal intubation complication | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
|
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Torticollis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
|
| Polycythaemia vera | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Mental disorder | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Alcohol detoxification | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
|
| Cardiac operation | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
|
| Tracheostomy tube removal | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
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.
| D013568 |
| Pathological Conditions, Signs and Symptoms |