N/A
N=1,372
MDs on Botox Utility (MOBILITY)
Blepharospasm · Torticollis · Strabismus · Muscle Spasticity
Bottom Line
View on ClinicalTrials.gov: NCT00535938 ↗Enrolled (actual)
1,372
Serious AEs
2.8%
Results posted
Sep 2014
Primary outcome: 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 — 0.650; 0.676; 0.020; -0.001 Scores on a Scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- botulinum toxin type A (Other)
- Age
- Pediatric, Adult, Older Adult · 14+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
0.650; 0.676; 0.020; -0.001 | — |
| PRIMARY Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Blepharospasm |
0.718; 0.754; 0.053; 0.014 | — |
| PRIMARY Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Hyperhidrosis |
0.782; 0.799; 0.010; -0.000 | — |
| 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 |
0.712; 0.733; NA; 0.018 | — |
| 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 |
0.621; 0.635; 0.002; 0.008 | — |
| 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 |
0.770; 0.759; 0.035; 0.002 | — |
| 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 |
0.570; 0.610; 0.060; 0.028 | — |
| SECONDARY BOTOX® Dose in Patients With Cervical Dystonia |
154.8; 242.7; 169.9; 246.4 | — |
| SECONDARY BOTOX® Dose in Patients With Blepharospasm |
42.9; 67.3; 47.8; 61.9 | — |
| SECONDARY BOTOX® Dose in Patients With Hyperhidrosis |
192.5; 203.6; 186.9; 206.5 | — |
| SECONDARY BOTOX® Dose in Patients With Adult Focal Spasticity |
253.0; 346.4; 295.4; 355.8 | — |
| SECONDARY BOTOX® Dose in Patients With Cerebral Palsy |
260.0; 245.5; 200.0; 252.5 | — |
| SECONDARY BOTOX® Dose in Patients With Facial Nerve Disorder |
31.3; 40.6; 30.9; 44.1 | — |
| SECONDARY BOTOX® Dose in Patients With "Other" Disorders |
157.2; 187.2; 173.4; 185.7 | — |
| SECONDARY Concurrent Procedure Resource Utilization Patterns |
0; 3; 2; 1; 1; 0 | — |
| SECONDARY Concurrent Surgical Procedure Resource Utilization Patterns |
2; 6; 1; 2; 0; 1 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00535938). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.