Blepharospasm, Muscle Spasticity, Strabismus, Torticollis
Conditions
Brief summary
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.
Interventions
OTHERbotulinum toxin type A
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.
Sponsors
Allergan
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who are eligible for BOTOX® treatment deemed medically necessary by their physician * Patient (and/or patient's authorized legal representative) should provide written informed consent; a patient under the age of 18 must review and sign the Patient Assent Form * Patients at the age of or over 14
Exclusion criteria
* Patient is participating in a clinical trial for any BOTOX® indication * Patient with any contraindications to use botulinum toxin A
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Cervical Dystonia | Baseline, SV1 (up to 505 days) | 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. |
| Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Blepharospasm | Baseline, SV1 (up to 542 days) | 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. |
| Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Hyperhidrosis | Baseline, SV1 (up to 1,273 days) | 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. |
| Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Cerebral Palsy | Baseline, SV1 (up to 925 days) | 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. |
| 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 | Baseline, SV1 (up to 1,562 days) | 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. |
| 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 | Baseline, SV1 (up to 765 days) | 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. |
| Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Other Disorders | Baseline, SV1 (up to 568 days) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concurrent Procedure Resource Utilization Patterns | Up to 1,785 days | 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) |
| BOTOX® Dose in Patients With Cervical Dystonia | Baseline, SV1 (up to 505 days) | 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. |
| Concurrent Surgical Procedure Resource Utilization Patterns | Up to 1,785 days | 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) |
| BOTOX® Dose in Patients With Blepharospasm | Baseline, SV1 (up to 542 days) | 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. |
| BOTOX® Dose in Patients With Hyperhidrosis | Baseline, SV1 (up to 1,273 days) | 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. |
| BOTOX® Dose in Patients With Adult Focal Spasticity | Baseline, SV1 (up to 1,562 days) | 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. |
| BOTOX® Dose in Patients With Cerebral Palsy | Baseline, SV1 (up to 925 days) | 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. |
| BOTOX® Dose in Patients With Facial Nerve Disorder | Baseline, SV1 (up to 765 days) | 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. |
| BOTOX® Dose in Patients With Other Disorders | Baseline, SV1 (up to 568 days) | 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. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Naïve to Botox® Treatment Initiating treatment with BOTOX® upon entry to the project. | 506 |
| Non-naïve to Botox® Treatment Receiving ongoing treatment with BOTOX® upon entry to the project. | 866 |
| Total | 1,372 |
Baseline characteristics
| Characteristic | Naïve to Botox® Treatment | Non-naïve to Botox® Treatment | Total |
|---|---|---|---|
| Age, Customized 14 to 17 years | 22 Participants | 28 Participants | 50 Participants |
| Age, Customized 18 to 65 years | 374 Participants | 641 Participants | 1015 Participants |
| Age, Customized >65 years | 110 Participants | 197 Participants | 307 Participants |
| Sex: Female, Male Female | 304 Participants | 577 Participants | 881 Participants |
| Sex: Female, Male Male | 202 Participants | 289 Participants | 491 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 506 | 0 / 866 |
| serious Total, serious adverse events | 5 / 506 | 33 / 866 |
Outcome results
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.
Time frame: Baseline, SV1 (up to 1,562 days)
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Naïve to Botox® Treatment | 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 | Baseline | 0.621 Scores on a Scale | Standard Deviation 0.111 |
| Naïve to Botox® Treatment | 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 | Change from Baseline at Week 4 (N=114, 201) | 0.002 Scores on a Scale | Standard Deviation 0.096 |
| Non-naïve to Botox® Treatment | 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 | Baseline | 0.635 Scores on a Scale | Standard Deviation 0.124 |
| Non-naïve to Botox® Treatment | 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 | Change from Baseline at Week 4 (N=114, 201) | 0.008 Scores on a Scale | Standard Deviation 0.096 |
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.
Time frame: Baseline, SV1 (up to 542 days)
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Naïve to Botox® Treatment | Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Blepharospasm | Baseline | 0.718 Scores on a Scale | Standard Deviation 0.122 |
| Naïve to Botox® Treatment | Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Blepharospasm | Change from Baseline at SV1 (N=21, 51) | 0.053 Scores on a Scale | Standard Deviation 0.156 |
| Non-naïve to Botox® Treatment | Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Blepharospasm | Baseline | 0.754 Scores on a Scale | Standard Deviation 0.132 |
| Non-naïve to Botox® Treatment | Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Blepharospasm | Change from Baseline at SV1 (N=21, 51) | 0.014 Scores on a Scale | Standard Deviation 0.12 |
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.
Time frame: Baseline, SV1 (up to 925 days)
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Naïve to Botox® Treatment | Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Cerebral Palsy | Baseline | 0.712 Scores on a Scale | Standard Deviation 0.131 |
| Naïve to Botox® Treatment | Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Cerebral Palsy | Change from Baseline at SV1 (N=0, 8) | NA Scores on a Scale | — |
| Non-naïve to Botox® Treatment | Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Cerebral Palsy | Baseline | 0.733 Scores on a Scale | Standard Deviation 0.117 |
| Non-naïve to Botox® Treatment | Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Cerebral Palsy | Change from Baseline at SV1 (N=0, 8) | 0.018 Scores on a Scale | Standard Deviation 0.114 |
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.
Time frame: Baseline, SV1 (up to 505 days)
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Naïve to Botox® Treatment | Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Cervical Dystonia | Baseline | 0.650 Scores on a Scale | Standard Deviation 0.154 |
| Naïve to Botox® Treatment | Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Cervical Dystonia | Change from Baseline at SV1 (N=33,174) | 0.020 Scores on a Scale | Standard Deviation 0.084 |
| Non-naïve to Botox® Treatment | Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Cervical Dystonia | Baseline | 0.676 Scores on a Scale | Standard Deviation 0.143 |
| Non-naïve to Botox® Treatment | Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Cervical Dystonia | Change from Baseline at SV1 (N=33,174) | -0.001 Scores on a Scale | Standard Deviation 0.104 |
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.
Time frame: Baseline, SV1 (up to 765 days)
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Naïve to Botox® Treatment | 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 | Baseline | 0.770 Scores on a Scale | Standard Deviation 0.134 |
| Naïve to Botox® Treatment | 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 | Change from Baseline at SV1 (N=30, 63) | 0.035 Scores on a Scale | Standard Deviation 0.158 |
| Non-naïve to Botox® Treatment | 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 | Baseline | 0.759 Scores on a Scale | Standard Deviation 0.134 |
| Non-naïve to Botox® Treatment | 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 | Change from Baseline at SV1 (N=30, 63) | 0.002 Scores on a Scale | Standard Deviation 0.111 |
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.
Time frame: Baseline, SV1 (up to 1,273 days)
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Naïve to Botox® Treatment | Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Hyperhidrosis | Baseline | 0.782 Scores on a Scale | Standard Deviation 0.129 |
| Naïve to Botox® Treatment | Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Hyperhidrosis | Change from Baseline at SV1 (N=58, 60) | 0.010 Scores on a Scale | Standard Deviation 0.136 |
| Non-naïve to Botox® Treatment | Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Hyperhidrosis | Baseline | 0.799 Scores on a Scale | Standard Deviation 0.115 |
| Non-naïve to Botox® Treatment | Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Hyperhidrosis | Change from Baseline at SV1 (N=58, 60) | -0.000 Scores on a Scale | Standard Deviation 0.124 |
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.
Time frame: Baseline, SV1 (up to 568 days)
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Naïve to Botox® Treatment | Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Other Disorders | Baseline | 0.570 Scores on a Scale | Standard Deviation 0.137 |
| Naïve to Botox® Treatment | Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Other Disorders | Change from Baseline at SV1 (N=33, 72) | 0.060 Scores on a Scale | Standard Deviation 0.086 |
| Non-naïve to Botox® Treatment | Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Other Disorders | Baseline | 0.610 Scores on a Scale | Standard Deviation 0.118 |
| Non-naïve to Botox® Treatment | Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Other Disorders | Change from Baseline at SV1 (N=33, 72) | 0.028 Scores on a Scale | Standard Deviation 0.113 |
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.
Time frame: Baseline, SV1 (up to 1,562 days)
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Naïve to Botox® Treatment | BOTOX® Dose in Patients With Adult Focal Spasticity | Baseline | 253.0 Units | Standard Deviation 132.6 |
| Naïve to Botox® Treatment | BOTOX® Dose in Patients With Adult Focal Spasticity | SV1 (N=127, 225) | 295.4 Units | Standard Deviation 152.4 |
| Non-naïve to Botox® Treatment | BOTOX® Dose in Patients With Adult Focal Spasticity | Baseline | 346.4 Units | Standard Deviation 157.4 |
| Non-naïve to Botox® Treatment | BOTOX® Dose in Patients With Adult Focal Spasticity | SV1 (N=127, 225) | 355.8 Units | Standard Deviation 150.2 |
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.
Time frame: Baseline, SV1 (up to 542 days)
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Naïve to Botox® Treatment | BOTOX® Dose in Patients With Blepharospasm | Baseline | 42.9 Units | Standard Deviation 13.8 |
| Naïve to Botox® Treatment | BOTOX® Dose in Patients With Blepharospasm | SV1 (N=23, 54) | 47.8 Units | Standard Deviation 22.7 |
| Non-naïve to Botox® Treatment | BOTOX® Dose in Patients With Blepharospasm | Baseline | 67.3 Units | Standard Deviation 54.3 |
| Non-naïve to Botox® Treatment | BOTOX® Dose in Patients With Blepharospasm | SV1 (N=23, 54) | 61.9 Units | Standard Deviation 39.5 |
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.
Time frame: Baseline, SV1 (up to 925 days)
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Naïve to Botox® Treatment | BOTOX® Dose in Patients With Cerebral Palsy | Baseline | 260.0 Units | Standard Deviation 89.4 |
| Naïve to Botox® Treatment | BOTOX® Dose in Patients With Cerebral Palsy | SV1 (N=1, 12) | 200.0 Units | — |
| Non-naïve to Botox® Treatment | BOTOX® Dose in Patients With Cerebral Palsy | Baseline | 245.5 Units | Standard Deviation 101.1 |
| Non-naïve to Botox® Treatment | BOTOX® Dose in Patients With Cerebral Palsy | SV1 (N=1, 12) | 252.5 Units | Standard Deviation 105.2 |
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.
Time frame: Baseline, SV1 (up to 505 days)
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Naïve to Botox® Treatment | BOTOX® Dose in Patients With Cervical Dystonia | Baseline | 154.8 Units | Standard Deviation 61.1 |
| Naïve to Botox® Treatment | BOTOX® Dose in Patients With Cervical Dystonia | SV1 (N=37, 187) | 169.9 Units | Standard Deviation 70.2 |
| Non-naïve to Botox® Treatment | BOTOX® Dose in Patients With Cervical Dystonia | Baseline | 242.7 Units | Standard Deviation 99.6 |
| Non-naïve to Botox® Treatment | BOTOX® Dose in Patients With Cervical Dystonia | SV1 (N=37, 187) | 246.4 Units | Standard Deviation 101.7 |
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.
Time frame: Baseline, SV1 (up to 765 days)
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Naïve to Botox® Treatment | BOTOX® Dose in Patients With Facial Nerve Disorder | Baseline | 31.3 Units | Standard Deviation 13.7 |
| Naïve to Botox® Treatment | BOTOX® Dose in Patients With Facial Nerve Disorder | SV1 (N=31, 69) | 30.9 Units | Standard Deviation 13.4 |
| Non-naïve to Botox® Treatment | BOTOX® Dose in Patients With Facial Nerve Disorder | Baseline | 40.6 Units | Standard Deviation 25.4 |
| Non-naïve to Botox® Treatment | BOTOX® Dose in Patients With Facial Nerve Disorder | SV1 (N=31, 69) | 44.1 Units | Standard Deviation 31.2 |
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.
Time frame: Baseline, SV1 (up to 1,273 days)
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Naïve to Botox® Treatment | BOTOX® Dose in Patients With Hyperhidrosis | Baseline | 192.5 Units | Standard Deviation 60.4 |
| Naïve to Botox® Treatment | BOTOX® Dose in Patients With Hyperhidrosis | SV1 (N=80, 97) | 186.9 Units | Standard Deviation 53.8 |
| Non-naïve to Botox® Treatment | BOTOX® Dose in Patients With Hyperhidrosis | Baseline | 203.6 Units | Standard Deviation 74.8 |
| Non-naïve to Botox® Treatment | BOTOX® Dose in Patients With Hyperhidrosis | SV1 (N=80, 97) | 206.5 Units | Standard Deviation 81.6 |
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.
Time frame: Baseline, SV1 (up to 568 days)
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Naïve to Botox® Treatment | BOTOX® Dose in Patients With Other Disorders | Baseline | 157.2 Units | Standard Deviation 82.4 |
| Naïve to Botox® Treatment | BOTOX® Dose in Patients With Other Disorders | SV1 (N=40, 75) | 173.4 Units | Standard Deviation 106.9 |
| Non-naïve to Botox® Treatment | BOTOX® Dose in Patients With Other Disorders | Baseline | 187.2 Units | Standard Deviation 106.8 |
| Non-naïve to Botox® Treatment | BOTOX® Dose in Patients With Other Disorders | SV1 (N=40, 75) | 185.7 Units | Standard Deviation 110.1 |
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)
Time frame: Up to 1,785 days
Population: Enrolled Cohort: All patients enrolled in the study
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Naïve to Botox® Treatment | Concurrent Procedure Resource Utilization Patterns | Eye therapeutic procedures | 1 Patients |
| Naïve to Botox® Treatment | Concurrent Procedure Resource Utilization Patterns | Lifestyle issues | 3 Patients |
| Naïve to Botox® Treatment | Concurrent Procedure Resource Utilization Patterns | Therapeutic procedures and supportive care NEC | 41 Patients |
| Naïve to Botox® Treatment | Concurrent Procedure Resource Utilization Patterns | Bone and joint therapeutic procedures | 0 Patients |
| Naïve to Botox® Treatment | Concurrent Procedure Resource Utilization Patterns | Economic and housing issues | 2 Patients |
| Non-naïve to Botox® Treatment | Concurrent Procedure Resource Utilization Patterns | Economic and housing issues | 1 Patients |
| Non-naïve to Botox® Treatment | Concurrent Procedure Resource Utilization Patterns | Bone and joint therapeutic procedures | 3 Patients |
| Non-naïve to Botox® Treatment | Concurrent Procedure Resource Utilization Patterns | Lifestyle issues | 9 Patients |
| Non-naïve to Botox® Treatment | Concurrent Procedure Resource Utilization Patterns | Eye therapeutic procedures | 0 Patients |
| Non-naïve to Botox® Treatment | Concurrent Procedure Resource Utilization Patterns | Therapeutic procedures and supportive care NEC | 69 Patients |
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)
Time frame: Up to 1,785 days
Population: Enrolled Cohort: All patients enrolled in the study
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Naïve to Botox® Treatment | Concurrent Surgical Procedure Resource Utilization Patterns | Head and neck therapeutic procedures | 0 Patients |
| Naïve to Botox® Treatment | Concurrent Surgical Procedure Resource Utilization Patterns | Renal and urinary tract therapeutic procedures | 0 Patients |
| Naïve to Botox® Treatment | Concurrent Surgical Procedure Resource Utilization Patterns | Gastrointestinal therapeutic procedures | 0 Patients |
| Naïve to Botox® Treatment | Concurrent Surgical Procedure Resource Utilization Patterns | Skin appendage conditions | 0 Patients |
| Naïve to Botox® Treatment | Concurrent Surgical Procedure Resource Utilization Patterns | Nervous system, skull&spine therapeutic procedures | 2 Patients |
| Naïve to Botox® Treatment | Concurrent Surgical Procedure Resource Utilization Patterns | Soft tissue therapeutic procedures | 2 Patients |
| Naïve to Botox® Treatment | Concurrent Surgical Procedure Resource Utilization Patterns | Eye therapeutic procedures | 1 Patients |
| Naïve to Botox® Treatment | Concurrent Surgical Procedure Resource Utilization Patterns | Therapeutic procedures and supportive care NEC | 1 Patients |
| Naïve to Botox® Treatment | Concurrent Surgical Procedure Resource Utilization Patterns | Renal/urinary tract investigations & urinalyses | 1 Patients |
| Naïve to Botox® Treatment | Concurrent Surgical Procedure Resource Utilization Patterns | Vascular therapeutic procedures | 0 Patients |
| Naïve to Botox® Treatment | Concurrent Surgical Procedure Resource Utilization Patterns | Bone and joint therapeutic procedures | 2 Patients |
| Non-naïve to Botox® Treatment | Concurrent Surgical Procedure Resource Utilization Patterns | Vascular therapeutic procedures | 1 Patients |
| Non-naïve to Botox® Treatment | Concurrent Surgical Procedure Resource Utilization Patterns | Eye therapeutic procedures | 2 Patients |
| Non-naïve to Botox® Treatment | Concurrent Surgical Procedure Resource Utilization Patterns | Bone and joint therapeutic procedures | 6 Patients |
| Non-naïve to Botox® Treatment | Concurrent Surgical Procedure Resource Utilization Patterns | Gastrointestinal therapeutic procedures | 1 Patients |
| Non-naïve to Botox® Treatment | Concurrent Surgical Procedure Resource Utilization Patterns | Head and neck therapeutic procedures | 1 Patients |
| Non-naïve to Botox® Treatment | Concurrent Surgical Procedure Resource Utilization Patterns | Nervous system, skull&spine therapeutic procedures | 6 Patients |
| Non-naïve to Botox® Treatment | Concurrent Surgical Procedure Resource Utilization Patterns | Renal/urinary tract investigations & urinalyses | 0 Patients |
| Non-naïve to Botox® Treatment | Concurrent Surgical Procedure Resource Utilization Patterns | Renal and urinary tract therapeutic procedures | 1 Patients |
| Non-naïve to Botox® Treatment | Concurrent Surgical Procedure Resource Utilization Patterns | Skin appendage conditions | 1 Patients |
| Non-naïve to Botox® Treatment | Concurrent Surgical Procedure Resource Utilization Patterns | Soft tissue therapeutic procedures | 6 Patients |
| Non-naïve to Botox® Treatment | Concurrent Surgical Procedure Resource Utilization Patterns | Therapeutic procedures and supportive care NEC | 1 Patients |