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MDs on Botox Utility (MOBILITY)

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ClinicalTrials.gov Identifier: NCT00535938
Recruitment Status : Completed
First Posted : September 27, 2007
Results First Posted : September 10, 2014
Last Update Posted : September 10, 2014
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Type Observational
Study Design Time Perspective: Prospective
Conditions Blepharospasm
Torticollis
Strabismus
Muscle Spasticity
Intervention Other: botulinum toxin type A
Enrollment 1372
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Naïve to Botox® Treatment Non-naïve to Botox® Treatment
Hide Arm/Group Description Initiating treatment with BOTOX® upon entry to the project. Receiving ongoing treatment with BOTOX® upon entry to the project.
Period Title: Overall Study
Started 506 866
Completed 115 404
Not Completed 391 462
Arm/Group Title Naïve to Botox® Treatment Non-naïve to Botox® Treatment Total
Hide Arm/Group Description Initiating treatment with BOTOX® upon entry to the project. Receiving ongoing treatment with BOTOX® upon entry to the project. Total of all reporting groups
Overall Number of Baseline Participants 506 866 1372
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 506 participants 866 participants 1372 participants
14 to 17 years 22 28 50
18 to 65 years 374 641 1015
>65 years 110 197 307
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 506 participants 866 participants 1372 participants
Female
304
  60.1%
577
  66.6%
881
  64.2%
Male
202
  39.9%
289
  33.4%
491
  35.8%
1.Primary Outcome
Title Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Cervical Dystonia
Hide Description 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Naïve to Botox® Treatment Non-naïve to Botox® Treatment
Hide Arm/Group Description:
Initiating treatment with BOTOX® upon entry to the project.
Receiving ongoing treatment with BOTOX® upon entry to the project.
Overall Number of Participants Analyzed 44 186
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
Baseline 0.650  (0.154) 0.676  (0.143)
Change from Baseline at SV1 (N=33,174) 0.020  (0.084) -0.001  (0.104)
2.Primary Outcome
Title Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Blepharospasm
Hide Description 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Naïve to Botox® Treatment Non-naïve to Botox® Treatment
Hide Arm/Group Description:
Initiating treatment with BOTOX® upon entry to the project.
Receiving ongoing treatment with BOTOX® upon entry to the project.
Overall Number of Participants Analyzed 23 56
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
Baseline 0.718  (0.122) 0.754  (0.132)
Change from Baseline at SV1 (N=21, 51) 0.053  (0.156) 0.014  (0.120)
3.Primary Outcome
Title Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Hyperhidrosis
Hide Description 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Naïve to Botox® Treatment Non-naïve to Botox® Treatment
Hide Arm/Group Description:
Initiating treatment with BOTOX® upon entry to the project.
Receiving ongoing treatment with BOTOX® upon entry to the project.
Overall Number of Participants Analyzed 101 107
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
Baseline 0.782  (0.129) 0.799  (0.115)
Change from Baseline at SV1 (N=58, 60) 0.010  (0.136) -0.000  (0.124)
4.Primary Outcome
Title Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Cerebral Palsy
Hide Description 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Naïve to Botox® Treatment Non-naïve to Botox® Treatment
Hide Arm/Group Description:
Initiating treatment with BOTOX® upon entry to the project.
Receiving ongoing treatment with BOTOX® upon entry to the project.
Overall Number of Participants Analyzed 3 15
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
Baseline 0.712  (0.131) 0.733  (0.117)
Change from Baseline at SV1 (N=0, 8) NA [1]   (NA) 0.018  (0.114)
[1]
No patients had data at this time point.
5.Primary Outcome
Title 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
Hide Description 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Naïve to Botox® Treatment Non-naïve to Botox® Treatment
Hide Arm/Group Description:
Initiating treatment with BOTOX® upon entry to the project.
Receiving ongoing treatment with BOTOX® upon entry to the project.
Overall Number of Participants Analyzed 149 241
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
Baseline 0.621  (0.111) 0.635  (0.124)
Change from Baseline at Week 4 (N=114, 201) 0.002  (0.096) 0.008  (0.096)
6.Primary Outcome
Title 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
Hide Description 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Naïve to Botox® Treatment Non-naïve to Botox® Treatment
Hide Arm/Group Description:
Initiating treatment with BOTOX® upon entry to the project.
Receiving ongoing treatment with BOTOX® upon entry to the project.
Overall Number of Participants Analyzed 38 77
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
Baseline 0.770  (0.134) 0.759  (0.134)
Change from Baseline at SV1 (N=30, 63) 0.035  (0.158) 0.002  (0.111)
7.Primary Outcome
Title Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With "Other" Disorders
Hide Description "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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Naïve to Botox® Treatment Non-naïve to Botox® Treatment
Hide Arm/Group Description:
Initiating treatment with BOTOX® upon entry to the project.
Receiving ongoing treatment with BOTOX® upon entry to the project.
Overall Number of Participants Analyzed 47 84
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
Baseline 0.570  (0.137) 0.610  (0.118)
Change from Baseline at SV1 (N=33, 72) 0.060  (0.086) 0.028  (0.113)
8.Secondary Outcome
Title BOTOX® Dose in Patients With Cervical Dystonia
Hide Description 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Naïve to Botox® Treatment Non-naïve to Botox® Treatment
Hide Arm/Group Description:
Initiating treatment with BOTOX® upon entry to the project.
Receiving ongoing treatment with BOTOX® upon entry to the project.
Overall Number of Participants Analyzed 48 202
Mean (Standard Deviation)
Unit of Measure: Units
Baseline 154.8  (61.1) 242.7  (99.6)
SV1 (N=37, 187) 169.9  (70.2) 246.4  (101.7)
9.Secondary Outcome
Title BOTOX® Dose in Patients With Blepharospasm
Hide Description 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Naïve to Botox® Treatment Non-naïve to Botox® Treatment
Hide Arm/Group Description:
Initiating treatment with BOTOX® upon entry to the project.
Receiving ongoing treatment with BOTOX® upon entry to the project.
Overall Number of Participants Analyzed 24 59
Mean (Standard Deviation)
Unit of Measure: Units
Baseline 42.9  (13.8) 67.3  (54.3)
SV1 (N=23, 54) 47.8  (22.7) 61.9  (39.5)
10.Secondary Outcome
Title BOTOX® Dose in Patients With Hyperhidrosis
Hide Description 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Naïve to Botox® Treatment Non-naïve to Botox® Treatment
Hide Arm/Group Description:
Initiating treatment with BOTOX® upon entry to the project.
Receiving ongoing treatment with BOTOX® upon entry to the project.
Overall Number of Participants Analyzed 151 137
Mean (Standard Deviation)
Unit of Measure: Units
Baseline 192.5  (60.4) 203.6  (74.8)
SV1 (N=80, 97) 186.9  (53.8) 206.5  (81.6)
11.Secondary Outcome
Title BOTOX® Dose in Patients With Adult Focal Spasticity
Hide Description 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Naïve to Botox® Treatment Non-naïve to Botox® Treatment
Hide Arm/Group Description:
Initiating treatment with BOTOX® upon entry to the project.
Receiving ongoing treatment with BOTOX® upon entry to the project.
Overall Number of Participants Analyzed 178 274
Mean (Standard Deviation)
Unit of Measure: Units
Baseline 253.0  (132.6) 346.4  (157.4)
SV1 (N=127, 225) 295.4  (152.4) 355.8  (150.2)
12.Secondary Outcome
Title BOTOX® Dose in Patients With Cerebral Palsy
Hide Description 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Naïve to Botox® Treatment Non-naïve to Botox® Treatment
Hide Arm/Group Description:
Initiating treatment with BOTOX® upon entry to the project.
Receiving ongoing treatment with BOTOX® upon entry to the project.
Overall Number of Participants Analyzed 5 22
Mean (Standard Deviation)
Unit of Measure: Units
Baseline 260.0  (89.4) 245.5  (101.1)
SV1 (N=1, 12) 200.0 [1]   (NA) 252.5  (105.2)
[1]
Standard deviation is not available as only 1 patient had data at this time point.
13.Secondary Outcome
Title BOTOX® Dose in Patients With Facial Nerve Disorder
Hide Description 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Naïve to Botox® Treatment Non-naïve to Botox® Treatment
Hide Arm/Group Description:
Initiating treatment with BOTOX® upon entry to the project.
Receiving ongoing treatment with BOTOX® upon entry to the project.
Overall Number of Participants Analyzed 42 80
Mean (Standard Deviation)
Unit of Measure: Units
Baseline 31.3  (13.7) 40.6  (25.4)
SV1 (N=31, 69) 30.9  (13.4) 44.1  (31.2)
14.Secondary Outcome
Title BOTOX® Dose in Patients With "Other" Disorders
Hide Description "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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Naïve to Botox® Treatment Non-naïve to Botox® Treatment
Hide Arm/Group Description:
Initiating treatment with BOTOX® upon entry to the project.
Receiving ongoing treatment with BOTOX® upon entry to the project.
Overall Number of Participants Analyzed 58 92
Mean (Standard Deviation)
Unit of Measure: Units
Baseline 157.2  (82.4) 187.2  (106.8)
SV1 (N=40, 75) 173.4  (106.9) 185.7  (110.1)
15.Secondary Outcome
Title Concurrent Procedure Resource Utilization Patterns
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Enrolled Cohort: All patients enrolled in the study
Arm/Group Title Naïve to Botox® Treatment Non-naïve to Botox® Treatment
Hide Arm/Group Description:
Initiating treatment with BOTOX® upon entry to the project.
Receiving ongoing treatment with BOTOX® upon entry to the project.
Overall Number of Participants Analyzed 506 866
Measure Type: Number
Unit of Measure: Patients
Bone and joint therapeutic procedures 0 3
Economic and housing issues 2 1
Eye therapeutic procedures 1 0
Lifestyle issues 3 9
Therapeutic procedures and supportive care NEC 41 69
16.Secondary Outcome
Title Concurrent Surgical Procedure Resource Utilization Patterns
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Enrolled Cohort: All patients enrolled in the study
Arm/Group Title Naïve to Botox® Treatment Non-naïve to Botox® Treatment
Hide Arm/Group Description:
Initiating treatment with BOTOX® upon entry to the project.
Receiving ongoing treatment with BOTOX® upon entry to the project.
Overall Number of Participants Analyzed 506 866
Measure Type: Number
Unit of Measure: Patients
Bone and joint therapeutic procedures 2 6
Eye therapeutic procedures 1 2
Gastrointestinal therapeutic procedures 0 1
Head and neck therapeutic procedures 0 1
Nervous system, skull&spine therapeutic procedures 2 6
Renal/urinary tract investigations & urinalyses 1 0
Renal and urinary tract therapeutic procedures 0 1
Skin appendage conditions 0 1
Soft tissue therapeutic procedures 2 6
Therapeutic procedures and supportive care NEC 1 1
Vascular therapeutic procedures 0 1
Time Frame [Not Specified]
Adverse Event Reporting Description 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).
 
Arm/Group Title Naïve to Botox® Treatment Non-naïve to Botox® Treatment
Hide Arm/Group Description Initiating treatment with BOTOX® upon entry to the project. Receiving ongoing treatment with BOTOX® upon entry to the project.
All-Cause Mortality
Naïve to Botox® Treatment Non-naïve to Botox® Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Naïve to Botox® Treatment Non-naïve to Botox® Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   5/506 (0.99%)   33/866 (3.81%) 
Cardiac disorders     
Myocardial Infarction  1  0/506 (0.00%)  2/866 (0.23%) 
Atrial Fibrillation  1  0/506 (0.00%)  1/866 (0.12%) 
Cardiomegaly  1  0/506 (0.00%)  1/866 (0.12%) 
Gastrointestinal disorders     
Dysphagia * 1  1/506 (0.20%)  4/866 (0.46%) 
Pancreatitis  1  0/506 (0.00%)  1/866 (0.12%) 
Abdominal Pain * 1  0/506 (0.00%)  1/866 (0.12%) 
Constipation * 1  0/506 (0.00%)  1/866 (0.12%) 
Small Intestinal Obstruction  1  0/506 (0.00%)  2/866 (0.23%) 
General disorders     
Death * 1  1/506 (0.20%)  6/866 (0.69%) 
Pyrexia * 1  0/506 (0.00%)  1/866 (0.12%) 
Asthenia  1  0/506 (0.00%)  2/866 (0.23%) 
Chest Pain * 1  0/506 (0.00%)  1/866 (0.12%) 
Local Swelling * 1  0/506 (0.00%)  1/866 (0.12%) 
Sudden Cardiac Death  1  0/506 (0.00%)  1/866 (0.12%) 
Hepatobiliary disorders     
Cholangitis  1  0/506 (0.00%)  1/866 (0.12%) 
Bile Duct Obstruction  1  0/506 (0.00%)  1/866 (0.12%) 
Cholecystitis Acute  1  0/506 (0.00%)  1/866 (0.12%) 
Gallbladder Disorder  1  0/506 (0.00%)  1/866 (0.12%) 
Infections and infestations     
Urosepsis  1  0/506 (0.00%)  1/866 (0.12%) 
Injury, poisoning and procedural complications     
Hip Fracture  1  1/506 (0.20%)  2/866 (0.23%) 
Foot Fracture  1  0/506 (0.00%)  1/866 (0.12%) 
Joint Injury * 1  0/506 (0.00%)  1/866 (0.12%) 
Investigations     
Weight Decreased * 1  0/506 (0.00%)  1/866 (0.12%) 
Metabolism and nutrition disorders     
Diabetes Mellitus  1  0/506 (0.00%)  1/866 (0.12%) 
Musculoskeletal and connective tissue disorders     
Foot Deformity * 1  1/506 (0.20%)  0/866 (0.00%) 
Intervertebral Disc Protrusion  1  0/506 (0.00%)  1/866 (0.12%) 
Muscle Tightness * 1  0/506 (0.00%)  1/866 (0.12%) 
Muscular Weakness * 1  0/506 (0.00%)  1/866 (0.12%) 
Arthralgia * 1  0/506 (0.00%)  1/866 (0.12%) 
Muscle Twitching * 1  0/506 (0.00%)  1/866 (0.12%) 
Spinal Column Stenosis  1  0/506 (0.00%)  1/866 (0.12%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasm Malignant  1  1/506 (0.20%)  0/866 (0.00%) 
Metastases to Lung  1  0/506 (0.00%)  1/866 (0.12%) 
Rectosigmoid Cancer  1  0/506 (0.00%)  1/866 (0.12%) 
Nervous system disorders     
Multiple Sclerosis  1  1/506 (0.20%)  0/866 (0.00%) 
Lumbar Radiculopathy * 1  0/506 (0.00%)  1/866 (0.12%) 
Lethargy * 1  0/506 (0.00%)  1/866 (0.12%) 
Dementia * 1  0/506 (0.00%)  1/866 (0.12%) 
Carpal Tunnel Syndrome  1  0/506 (0.00%)  1/866 (0.12%) 
Dyskinesia  1  0/506 (0.00%)  1/866 (0.12%) 
Grand Mal Convulsion * 1  0/506 (0.00%)  1/866 (0.12%) 
Head Titubation * 1  0/506 (0.00%)  1/866 (0.12%) 
Headache * 1  0/506 (0.00%)  1/866 (0.12%) 
Loss of Consciousness * 1  0/506 (0.00%)  1/866 (0.12%) 
Parkinson's Disease  1  0/506 (0.00%)  1/866 (0.12%) 
Psychiatric disorders     
Depression * 1  0/506 (0.00%)  2/866 (0.23%) 
Mental Disorder  1  0/506 (0.00%)  1/866 (0.12%) 
Renal and urinary disorders     
Haematuria  1  0/506 (0.00%)  1/866 (0.12%) 
Pollakiuria  1  0/506 (0.00%)  1/866 (0.12%) 
Respiratory, thoracic and mediastinal disorders     
Pleural Effusion  1  0/506 (0.00%)  1/866 (0.12%) 
Surgical and medical procedures     
Haemorrhoid Operation  1  0/506 (0.00%)  1/866 (0.12%) 
Carpal Tunnel Decompression  1  0/506 (0.00%)  1/866 (0.12%) 
Knee Operation  1  0/506 (0.00%)  1/866 (0.12%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA version 9.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Naïve to Botox® Treatment Non-naïve to Botox® Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   0/506 (0.00%)   0/866 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is 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.
Results Point of Contact
Name/Title: Vice President Medical Affairs,
Organization: Allergan, Inc
Phone: 714-246-4500
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00535938     History of Changes
Other Study ID Numbers: AGN/MMC B00705
First Submitted: September 25, 2007
First Posted: September 27, 2007
Results First Submitted: September 4, 2014
Results First Posted: September 10, 2014
Last Update Posted: September 10, 2014