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The MOBILITY Project is a prospective, non-randomized, observational, multi-centre evaluation of Health Utility via the SF-12® Health Survey Scores and the SF-6D in patients receiving BOTOX® for therapeutic use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Naïve to Botox® treatment | Initiating treatment with BOTOX® upon entry to the project. |
| |
| Non-naïve to Botox® treatment | Receiving ongoing treatment with BOTOX® upon entry to the project. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| botulinum toxin type A | Other | There will be no protocol-mandated intervention with regard to physician treatment choice or management of patient condition once the patient is enrolled in the project. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Cervical Dystonia | Cervical dystonia is a condition in which the neck muscles contract involuntarily, causing the head to turn to one side, forward or backward. The SF-12 consists of 12 questions on various health questions. Health utility is a numerical indicator of a person's preferences for a given health state or health outcome. Health utility is a sub-score ranging from 0 (death) to 1 (perfect health) and is calculated from the SF-12 total score based on the following items: physical functioning, role participation, social functioning, bodily pain, mental health, and vitality and is termed SF-6D. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician's discretion and was a maximum of 505 days for patients with cervical dystonia. | Baseline, SV1 (up to 505 days) |
| Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Blepharospasm | Blepharospasm is a condition in which the eyelids blink/close involuntarily. The SF-12 consists of 12 questions on various health questions. Health utility is a numerical indicator of a person's preferences for a given health state or health outcome. Health utility is a sub-score ranging from 0 (death) to 1 (perfect health) and is calculated from the SF-12 total score based on the following items: physical functioning, role participation, social functioning, bodily pain, mental health, and vitality and is termed SF-6D. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician's discretion and was a maximum of 542 days for patients with blepharospasm. | Baseline, SV1 (up to 542 days) |
| Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Hyperhidrosis | Hyperhidrosis is a condition causing excessive sweating, regardless of temperature or exercise. The SF-12 consists of 12 questions on various health questions. Health utility is a numerical indicator of a person's preferences for a given health state or health outcome. Health utility is a sub-score ranging from 0 (death) to 1 (perfect health) and is calculated from the SF-12 total score based on the following items: physical functioning, role participation, social functioning, bodily pain, mental health, and vitality and is termed SF-6D. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician's discretion and was a maximum of 1,273 days for patients with hyperhidrosis. |
| Measure | Description | Time Frame |
|---|---|---|
| BOTOX® Dose in Patients With Cervical Dystonia | Cervical dystonia is a condition in which the neck muscles contract involuntarily, causing the head to turn to one side, forward or backward. The BOTOX® dose was assessed in this patient population. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician's discretion and was a maximum of 505 days for patients with cervical dystonia. |
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Inclusion Criteria:
Exclusion Criteria:
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Community sample
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toronto | Ontario | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | Naïve to Botox® Treatment | Initiating treatment with BOTOX® upon entry to the project. |
| FG001 | Non-naïve to Botox® Treatment | Receiving ongoing treatment with BOTOX® upon entry to the project. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Naïve to Botox® Treatment | Initiating treatment with BOTOX® upon entry to the project. |
| BG001 | Non-naïve to Botox® Treatment | Receiving ongoing treatment with BOTOX® upon entry to the project. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Cervical Dystonia | Cervical dystonia is a condition in which the neck muscles contract involuntarily, causing the head to turn to one side, forward or backward. The SF-12 consists of 12 questions on various health questions. Health utility is a numerical indicator of a person's preferences for a given health state or health outcome. Health utility is a sub-score ranging from 0 (death) to 1 (perfect health) and is calculated from the SF-12 total score based on the following items: physical functioning, role participation, social functioning, bodily pain, mental health, and vitality and is termed SF-6D. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician's discretion and was a maximum of 505 days for patients with cervical dystonia. | Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, SV1 (up to 505 days) |
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The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
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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 | Naïve to Botox® Treatment | Initiating treatment with BOTOX® upon entry to the project. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Foot Deformity | Musculoskeletal and connective tissue disorders | MedDRA version 9.1 | 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 |
|---|---|
| D001764 | Blepharospasm |
| D014103 | Torticollis |
| D013285 | Strabismus |
| D009128 | Muscle Spasticity |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
| D004421 | Dystonia |
| D020820 | Dyskinesias |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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| Baseline, SV1 (up to 1,273 days) |
| Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Cerebral Palsy | Cerebral Palsy is a disability resulting in muscular incoordination and speech disturbances. The SF-12 consists of 12 questions on various health questions. Health utility is a numerical indicator of a person's preferences for a given health state or health outcome. Health utility is a sub-score ranging from 0 (death) to 1 (perfect health) and is calculated from the SF-12 total score based on the following items: physical functioning, role participation, social functioning, bodily pain, mental health, and vitality and is termed SF-6D. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician's discretion and was a maximum of 925 days for patients with cerebral palsy. | Baseline, SV1 (up to 925 days) |
| Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Adult Focal Spasticity | Adult Focal Spasticity is a condition in which muscles are continuously tight or stiff in a certain area. The SF-12 consists of 12 questions on various health questions. Health utility is a numerical indicator of a person's preferences for a given health state or health outcome. Health utility is a sub-score ranging from 0 (death) to 1 (perfect health) and is calculated from the SF-12 total score based on the following items: physical functioning, role participation, social functioning, bodily pain, mental health, and vitality and is termed SF-6D. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician's discretion and was a maximum of 1,562 days for patients with adult focal spasticity. | Baseline, SV1 (up to 1,562 days) |
| Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Facial Nerve Disorder | Facial nerve disorder is a condition causing twitching, weakness or paralysis of the face. The SF-12 consists of 12 questions on various health questions. Health utility is a numerical indicator of a person's preferences for a given health state or health outcome. Health utility is a sub-score ranging from 0 (death) to 1 (perfect health) and is calculated from the SF-12 total score based on the following items: physical functioning, role participation, social functioning, bodily pain, mental health, and vitality and is termed SF-6D. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician's discretion and was a maximum of 765 days for patients with facial nerve disorder. | Baseline, SV1 (up to 765 days) |
| Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With "Other" Disorders | "Other" disorders include focal dystonia (involuntary muscular contractions/abnormal postures), headache, pain, tics (sudden, repetitive, nonrhythmic movements/vocalizations), tremors (unintentional, rhythmic muscle movements), and other nonspecified disorders. The SF-12 is 12 questions on various health questions. Health utility is a numerical indicator of a person's preference for a given health state or health outcome. Health utility is a sub-score ranging from 0(death) to 1(perfect health) calculated from the SF-12 total score based on: physical functioning, role participation, social functioning, bodily pain, mental health, and vitality and is termed SF-6D. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. The length of time between Baseline and SV1 is scheduled at the physician's discretion and was a maximum of 568 days for patients with "other" disorders. | Baseline, SV1 (up to 568 days) |
| Baseline, SV1 (up to 505 days) |
| BOTOX® Dose in Patients With Blepharospasm | Blepharospasm is a condition in which the eyelids blink/close involuntarily. The BOTOX® dose was assessed in this patient population. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician's discretion and was a maximum of 542 days for patients with blepharospasm. | Baseline, SV1 (up to 542 days) |
| BOTOX® Dose in Patients With Hyperhidrosis | Hyperhidrosis is a condition causing excessive sweating, regardless of temperature or exercise. The BOTOX® dose was assessed in this patient population. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician's discretion and was a maximum of 1,273 days for patients with hyperhidrosis. | Baseline, SV1 (up to 1,273 days) |
| BOTOX® Dose in Patients With Adult Focal Spasticity | Adult Focal Spasticity is a condition in which muscles are continuously tight or stiff in a certain area. The BOTOX® dose was assessed in this patient population. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician's discretion and was a maximum of 1,562 days for patients with adult focal spasticity. | Baseline, SV1 (up to 1,562 days) |
| BOTOX® Dose in Patients With Cerebral Palsy | Cerebral Palsy is a disability resulting in muscular incoordination and speech disturbances. The BOTOX® dose was assessed in this patient population. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician's discretion and was a maximum of 925 days for patients with cerebral palsy. | Baseline, SV1 (up to 925 days) |
| BOTOX® Dose in Patients With Facial Nerve Disorder | Facial nerve disorder is a condition causing twitching, weakness or paralysis of the face. The BOTOX® dose was assessed in this patient population. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician's discretion and was a maximum of 765 days for patients with facial nerve disorder. | Baseline, SV1 (up to 765 days) |
| BOTOX® Dose in Patients With "Other" Disorders | "Other" disorders include focal dystonia (involuntary muscular contractions/abnormal postures), headache, pain, tics (sudden, repetitive, nonrhythmic movements/vocalizations), tremors (unintentional, rhythmic muscle movements), and other nonspecified disorders. The BOTOX® dose was assessed in this patient population. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician's discretion and was a maximum of 568 days for patients with "other" disorders. | Baseline, SV1 (up to 568 days) |
| Concurrent Procedure Resource Utilization Patterns | Resource utilization patterns are assessed in terms of concurrent procedures utilized during the study (up to 1,785 days across all indications) and are grouped by highest level term. (Note: NEC=not elsewhere classified) | Up to 1,785 days |
| Concurrent Surgical Procedure Resource Utilization Patterns | Resource utilization patterns are assessed in terms of concurrent surgical procedures utilized during the study (up to 1,785 days across all indications) and are grouped by highest level term. (Note: NEC=not elsewhere classified) | Up to 1,785 days |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Naïve to Botox® Treatment | Initiating treatment with BOTOX® upon entry to the project. |
| OG001 | Non-naïve to Botox® Treatment | Receiving ongoing treatment with BOTOX® upon entry to the project. |
|
|
| Primary | Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Blepharospasm | Blepharospasm is a condition in which the eyelids blink/close involuntarily. The SF-12 consists of 12 questions on various health questions. Health utility is a numerical indicator of a person's preferences for a given health state or health outcome. Health utility is a sub-score ranging from 0 (death) to 1 (perfect health) and is calculated from the SF-12 total score based on the following items: physical functioning, role participation, social functioning, bodily pain, mental health, and vitality and is termed SF-6D. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician's discretion and was a maximum of 542 days for patients with blepharospasm. | Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, SV1 (up to 542 days) |
|
|
|
| Primary | Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Hyperhidrosis | Hyperhidrosis is a condition causing excessive sweating, regardless of temperature or exercise. The SF-12 consists of 12 questions on various health questions. Health utility is a numerical indicator of a person's preferences for a given health state or health outcome. Health utility is a sub-score ranging from 0 (death) to 1 (perfect health) and is calculated from the SF-12 total score based on the following items: physical functioning, role participation, social functioning, bodily pain, mental health, and vitality and is termed SF-6D. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician's discretion and was a maximum of 1,273 days for patients with hyperhidrosis. | Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, SV1 (up to 1,273 days) |
|
|
|
| Primary | Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Cerebral Palsy | Cerebral Palsy is a disability resulting in muscular incoordination and speech disturbances. The SF-12 consists of 12 questions on various health questions. Health utility is a numerical indicator of a person's preferences for a given health state or health outcome. Health utility is a sub-score ranging from 0 (death) to 1 (perfect health) and is calculated from the SF-12 total score based on the following items: physical functioning, role participation, social functioning, bodily pain, mental health, and vitality and is termed SF-6D. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician's discretion and was a maximum of 925 days for patients with cerebral palsy. | Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, SV1 (up to 925 days) |
|
|
|
| Primary | Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Adult Focal Spasticity | Adult Focal Spasticity is a condition in which muscles are continuously tight or stiff in a certain area. The SF-12 consists of 12 questions on various health questions. Health utility is a numerical indicator of a person's preferences for a given health state or health outcome. Health utility is a sub-score ranging from 0 (death) to 1 (perfect health) and is calculated from the SF-12 total score based on the following items: physical functioning, role participation, social functioning, bodily pain, mental health, and vitality and is termed SF-6D. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician's discretion and was a maximum of 1,562 days for patients with adult focal spasticity. | Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, SV1 (up to 1,562 days) |
|
|
|
| Primary | Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Facial Nerve Disorder | Facial nerve disorder is a condition causing twitching, weakness or paralysis of the face. The SF-12 consists of 12 questions on various health questions. Health utility is a numerical indicator of a person's preferences for a given health state or health outcome. Health utility is a sub-score ranging from 0 (death) to 1 (perfect health) and is calculated from the SF-12 total score based on the following items: physical functioning, role participation, social functioning, bodily pain, mental health, and vitality and is termed SF-6D. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician's discretion and was a maximum of 765 days for patients with facial nerve disorder. | Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, SV1 (up to 765 days) |
|
|
|
| Primary | Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With "Other" Disorders | "Other" disorders include focal dystonia (involuntary muscular contractions/abnormal postures), headache, pain, tics (sudden, repetitive, nonrhythmic movements/vocalizations), tremors (unintentional, rhythmic muscle movements), and other nonspecified disorders. The SF-12 is 12 questions on various health questions. Health utility is a numerical indicator of a person's preference for a given health state or health outcome. Health utility is a sub-score ranging from 0(death) to 1(perfect health) calculated from the SF-12 total score based on: physical functioning, role participation, social functioning, bodily pain, mental health, and vitality and is termed SF-6D. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. The length of time between Baseline and SV1 is scheduled at the physician's discretion and was a maximum of 568 days for patients with "other" disorders. | Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, SV1 (up to 568 days) |
|
|
|
| Secondary | BOTOX® Dose in Patients With Cervical Dystonia | Cervical dystonia is a condition in which the neck muscles contract involuntarily, causing the head to turn to one side, forward or backward. The BOTOX® dose was assessed in this patient population. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician's discretion and was a maximum of 505 days for patients with cervical dystonia. | Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point | Posted | Mean | Standard Deviation | Units | Baseline, SV1 (up to 505 days) |
|
|
|
| Secondary | BOTOX® Dose in Patients With Blepharospasm | Blepharospasm is a condition in which the eyelids blink/close involuntarily. The BOTOX® dose was assessed in this patient population. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician's discretion and was a maximum of 542 days for patients with blepharospasm. | Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point | Posted | Mean | Standard Deviation | Units | Baseline, SV1 (up to 542 days) |
|
|
|
| Secondary | BOTOX® Dose in Patients With Hyperhidrosis | Hyperhidrosis is a condition causing excessive sweating, regardless of temperature or exercise. The BOTOX® dose was assessed in this patient population. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician's discretion and was a maximum of 1,273 days for patients with hyperhidrosis. | Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point | Posted | Mean | Standard Deviation | Units | Baseline, SV1 (up to 1,273 days) |
|
|
|
| Secondary | BOTOX® Dose in Patients With Adult Focal Spasticity | Adult Focal Spasticity is a condition in which muscles are continuously tight or stiff in a certain area. The BOTOX® dose was assessed in this patient population. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician's discretion and was a maximum of 1,562 days for patients with adult focal spasticity. | Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point | Posted | Mean | Standard Deviation | Units | Baseline, SV1 (up to 1,562 days) |
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| Secondary | BOTOX® Dose in Patients With Cerebral Palsy | Cerebral Palsy is a disability resulting in muscular incoordination and speech disturbances. The BOTOX® dose was assessed in this patient population. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician's discretion and was a maximum of 925 days for patients with cerebral palsy. | Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point | Posted | Mean | Standard Deviation | Units | Baseline, SV1 (up to 925 days) |
|
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|
| Secondary | BOTOX® Dose in Patients With Facial Nerve Disorder | Facial nerve disorder is a condition causing twitching, weakness or paralysis of the face. The BOTOX® dose was assessed in this patient population. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician's discretion and was a maximum of 765 days for patients with facial nerve disorder. | Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point | Posted | Mean | Standard Deviation | Units | Baseline, SV1 (up to 765 days) |
|
|
|
| Secondary | BOTOX® Dose in Patients With "Other" Disorders | "Other" disorders include focal dystonia (involuntary muscular contractions/abnormal postures), headache, pain, tics (sudden, repetitive, nonrhythmic movements/vocalizations), tremors (unintentional, rhythmic muscle movements), and other nonspecified disorders. The BOTOX® dose was assessed in this patient population. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician's discretion and was a maximum of 568 days for patients with "other" disorders. | Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point | Posted | Mean | Standard Deviation | Units | Baseline, SV1 (up to 568 days) |
|
|
|
| Secondary | Concurrent Procedure Resource Utilization Patterns | Resource utilization patterns are assessed in terms of concurrent procedures utilized during the study (up to 1,785 days across all indications) and are grouped by highest level term. (Note: NEC=not elsewhere classified) | Enrolled Cohort: All patients enrolled in the study | Posted | Number | Patients | Up to 1,785 days |
|
|
|
| Secondary | Concurrent Surgical Procedure Resource Utilization Patterns | Resource utilization patterns are assessed in terms of concurrent surgical procedures utilized during the study (up to 1,785 days across all indications) and are grouped by highest level term. (Note: NEC=not elsewhere classified) | Enrolled Cohort: All patients enrolled in the study | Posted | Number | Patients | Up to 1,785 days |
|
|
|
| 5 |
| 506 |
| 0 |
| 506 |
| EG001 | Non-naïve to Botox® Treatment | Receiving ongoing treatment with BOTOX® upon entry to the project. | 33 | 866 | 0 | 866 |
| Dysphagia | Gastrointestinal disorders | MedDRA version 9.1 | Non-systematic Assessment |
|
| Multiple Sclerosis | Nervous system disorders | MedDRA version 9.1 | Systematic Assessment |
|
| Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 9.1 | Systematic Assessment |
|
| Death | General disorders | MedDRA version 9.1 | Non-systematic Assessment |
|
| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | MedDRA version 9.1 | Systematic Assessment |
|
| Lumbar Radiculopathy | Nervous system disorders | MedDRA version 9.1 | Non-systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA version 9.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA version 9.1 | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA version 9.1 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA version 9.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA version 9.1 | Systematic Assessment |
|
| Hip Fracture | Injury, poisoning and procedural complications | MedDRA version 9.1 | Systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA version 9.1 | Systematic Assessment |
|
| Bile Duct Obstruction | Hepatobiliary disorders | MedDRA version 9.1 | Systematic Assessment |
|
| Cholecystitis Acute | Hepatobiliary disorders | MedDRA version 9.1 | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA version 9.1 | Systematic Assessment |
|
| Metastases to Lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 9.1 | Systematic Assessment |
|
| Rectosigmoid Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 9.1 | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA version 9.1 | Non-systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA version 9.1 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA version 9.1 | Non-systematic Assessment |
|
| Haemorrhoid Operation | Surgical and medical procedures | MedDRA version 9.1 | Systematic Assessment |
|
| Dementia | Nervous system disorders | MedDRA version 9.1 | Non-systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | MedDRA version 9.1 | Systematic Assessment |
|
| Muscle Tightness | Musculoskeletal and connective tissue disorders | MedDRA version 9.1 | Non-systematic Assessment |
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| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA version 9.1 | Non-systematic Assessment |
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| Atrial Fibrillation | Cardiac disorders | MedDRA version 9.1 | Systematic Assessment |
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| Cardiomegaly | Cardiac disorders | MedDRA version 9.1 | Systematic Assessment |
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| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA version 9.1 | Systematic Assessment |
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| Chest Pain | General disorders | MedDRA version 9.1 | Non-systematic Assessment |
|
| Local Swelling | General disorders | MedDRA version 9.1 | Non-systematic Assessment |
|
| Sudden Cardiac Death | General disorders | MedDRA version 9.1 | Systematic Assessment |
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| Gallbladder Disorder | Hepatobiliary disorders | MedDRA version 9.1 | Systematic Assessment |
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| Foot Fracture | Injury, poisoning and procedural complications | MedDRA version 9.1 | Systematic Assessment |
|
| Joint Injury | Injury, poisoning and procedural complications | MedDRA version 9.1 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 9.1 | Non-systematic Assessment |
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| Muscle Twitching | Musculoskeletal and connective tissue disorders | MedDRA version 9.1 | Non-systematic Assessment |
|
| Spinal Column Stenosis | Musculoskeletal and connective tissue disorders | MedDRA version 9.1 | Systematic Assessment |
|
| Carpal Tunnel Syndrome | Nervous system disorders | MedDRA version 9.1 | Systematic Assessment |
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| Dyskinesia | Nervous system disorders | MedDRA version 9.1 | Systematic Assessment |
|
| Grand Mal Convulsion | Nervous system disorders | MedDRA version 9.1 | Non-systematic Assessment |
|
| Head Titubation | Nervous system disorders | MedDRA version 9.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA version 9.1 | Non-systematic Assessment |
|
| Loss of Consciousness | Nervous system disorders | MedDRA version 9.1 | Non-systematic Assessment |
|
| Carpal Tunnel Decompression | Surgical and medical procedures | MedDRA version 9.1 | Systematic Assessment |
|
| Knee Operation | Surgical and medical procedures | MedDRA version 9.1 | Systematic Assessment |
|
| Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA version 9.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA version 9.1 | Non-systematic Assessment |
|
| Mental Disorder | Psychiatric disorders | MedDRA version 9.1 | Systematic Assessment |
|
| Parkinson's Disease | Nervous system disorders | MedDRA version 9.1 | Systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA version 9.1 | Systematic Assessment |
|
| Weight Decreased | Investigations | MedDRA version 9.1 | 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 at least 4 weeks from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015835 | Ocular Motility Disorders |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| Eye therapeutic procedures |
|
| Lifestyle issues |
|
| Therapeutic procedures and supportive care NEC |
|
| Gastrointestinal therapeutic procedures |
|
| Head and neck therapeutic procedures |
|
| Nervous system, skull&spine therapeutic procedures |
|
| Renal/urinary tract investigations & urinalyses |
|
| Renal and urinary tract therapeutic procedures |
|
| Skin appendage conditions |
|
| Soft tissue therapeutic procedures |
|
| Therapeutic procedures and supportive care NEC |
|
| Vascular therapeutic procedures |
|