Trial · NCT00535938
MDs on Botox Utility (MOBILITY)
NCT00535938, Completed, Allergan; results first posted 2014-09-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. MDs on Botox Utility (MOBILITY). Trials, record NCT00535938. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00535938
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- MDs on Botox Utility (MOBILITY)
- NCT number
- NCT00535938
- Status
- Completed
- Enrollment
- 1,372 participants, actual
- Lead sponsor
- Allergan
- Conditions
- Blepharospasm, Torticollis, Strabismus, Muscle Spasticity
- Interventions
- botulinum toxin type A
- First posted
- 2007-09-27
- Last updated
- 2014-09-10
- Results first posted
- 2014-09-10
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | 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. |
| Primary | 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. |
| Primary | 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. |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| 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 | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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 | Baseline, SV1 (up to 505 days) | 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 | Scores on a Scale | MEAN |
| PRIMARY | 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) | 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 | Scores on a Scale | MEAN |
| PRIMARY | 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) | 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 | Scores on a Scale | MEAN |
| 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 | Baseline, SV1 (up to 925 days) | 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 | Scores on a Scale | MEAN |
| 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 | Baseline, SV1 (up to 1,562 days) | 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 | Scores on a Scale | MEAN |
| 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 | Baseline, SV1 (up to 765 days) | 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 | Scores on a Scale | MEAN |
| 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 | Baseline, SV1 (up to 568 days) | 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 | Scores on a Scale | MEAN |
| SECONDARY | BOTOX® Dose in Patients With Cervical Dystonia | Baseline, SV1 (up to 505 days) | 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 | Units | MEAN |
| SECONDARY | BOTOX® Dose in Patients With Blepharospasm | Baseline, SV1 (up to 542 days) | 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 | Units | MEAN |
| SECONDARY | BOTOX® Dose in Patients With Hyperhidrosis | Baseline, SV1 (up to 1,273 days) | 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 | Units | MEAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group88
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Cervical Dystonia | Naïve to Botox® Treatment | Baseline | 0.650 | Standard Deviation 0.154 | Scores on a Scale |
| Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Cervical Dystonia | Non-naïve to Botox® Treatment | Baseline | 0.676 | Standard Deviation 0.143 | Scores on a Scale |
| Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Cervical Dystonia | Naïve to Botox® Treatment | Change from Baseline at SV1 (N=33,174) | 0.020 | Standard Deviation 0.084 | Scores on a Scale |
| Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Cervical Dystonia | Non-naïve to Botox® Treatment | Change from Baseline at SV1 (N=33,174) | -0.001 | Standard Deviation 0.104 | Scores on a Scale |
| Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Blepharospasm | Naïve to Botox® Treatment | Baseline | 0.718 | Standard Deviation 0.122 | Scores on a Scale |
| Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Blepharospasm | Non-naïve to Botox® Treatment | Baseline | 0.754 | Standard Deviation 0.132 | Scores on a Scale |
| Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Blepharospasm | Naïve to Botox® Treatment | Change from Baseline at SV1 (N=21, 51) | 0.053 | Standard Deviation 0.156 | Scores on a Scale |
| Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Blepharospasm | Non-naïve to Botox® Treatment | Change from Baseline at SV1 (N=21, 51) | 0.014 | Standard Deviation 0.120 | Scores on a Scale |
| Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Hyperhidrosis | Naïve to Botox® Treatment | Baseline | 0.782 | Standard Deviation 0.129 | Scores on a Scale |
| Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Hyperhidrosis | Non-naïve to Botox® Treatment | Baseline | 0.799 | Standard Deviation 0.115 | Scores on a Scale |
1 to 10 of 88Source ClinicalTrials.gov
See all 88 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Naïve to Botox® Treatment | 506 | |
| Overall Study | STARTED | Non-naïve to Botox® Treatment | 866 | |
| Overall Study | COMPLETED | Naïve to Botox® Treatment | 115 | |
| Overall Study | COMPLETED | Non-naïve to Botox® Treatment | 404 | |
| Overall Study | NOT COMPLETED | Naïve to Botox® Treatment | 391 | |
| Overall Study | NOT COMPLETED | Non-naïve to Botox® Treatment | 462 |
Source ClinicalTrials.gov
Adverse events106
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Foot Deformity | Musculoskeletal and connective tissue disorders | Naïve to Botox® Treatment | 1 | 506 | |
| serious | Foot Deformity | Musculoskeletal and connective tissue disorders | Non-naïve to Botox® Treatment | 0 | 866 | |
| serious | Dysphagia | Gastrointestinal disorders | Naïve to Botox® Treatment | 1 | 506 | |
| serious | Dysphagia | Gastrointestinal disorders | Non-naïve to Botox® Treatment | 4 | 866 | |
| serious | Multiple Sclerosis | Nervous system disorders | Naïve to Botox® Treatment | 1 | 506 | |
| serious | Multiple Sclerosis | Nervous system disorders | Non-naïve to Botox® Treatment | 0 | 866 | |
| serious | Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Naïve to Botox® Treatment | 1 | 506 | |
| serious | Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-naïve to Botox® Treatment | 0 | 866 | |
| serious | Death | General disorders | Naïve to Botox® Treatment | 1 | 506 | |
| serious | Death | General disorders | Non-naïve to Botox® Treatment | 6 | 866 |
1 to 10 of 106Source ClinicalTrials.gov
See all 106 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Naïve to Botox® Treatment | ||
| Total, all-cause mortality | Non-naïve to Botox® Treatment | ||
| Total, other adverse events | Naïve to Botox® Treatment | 0 | 506 |
| Total, other adverse events | Non-naïve to Botox® Treatment | 0 | 866 |
| Total, serious adverse events | Naïve to Botox® Treatment | 5 | 506 |
| Total, serious adverse events | Non-naïve to Botox® Treatment | 33 | 866 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Naïve to Botox® Treatment vs Non-naïve to Botox® Treatment: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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