Clinical trial NCT00535938: MDs on Botox Utility (MOBILITY)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blepharospasm
Torticollis
Strabismus
Muscle Spasticity
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2007-09-27
Enrollment: 1372
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample

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.


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

Primary outcomes:
measure: Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Cervical Dystonia
timeFrame: Baseline, SV1 (up to 505 days)
measure: Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Blepharospasm
timeFrame: Baseline, SV1 (up to 542 days)
measure: Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Hyperhidrosis
timeFrame: Baseline, SV1 (up to 1,273 days)
measure: Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Cerebral Palsy
timeFrame: Baseline, SV1 (up to 925 days)
measure: 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
timeFrame: Baseline, SV1 (up to 1,562 days)
measure: 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
timeFrame: Baseline, SV1 (up to 765 days)
measure: Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With "Other" Disorders
timeFrame: Baseline, SV1 (up to 568 days)
Secondary outcomes:
measure: BOTOX® Dose in Patients With Cervical Dystonia
timeFrame: Baseline, SV1 (up to 505 days)
measure: BOTOX® Dose in Patients With Blepharospasm
timeFrame: Baseline, SV1 (up to 542 days)
measure: BOTOX® Dose in Patients With Hyperhidrosis
timeFrame: Baseline, SV1 (up to 1,273 days)
measure: BOTOX® Dose in Patients With Adult Focal Spasticity
timeFrame: Baseline, SV1 (up to 1,562 days)
measure: BOTOX® Dose in Patients With Cerebral Palsy
timeFrame: Baseline, SV1 (up to 925 days)
measure: BOTOX® Dose in Patients With Facial Nerve Disorder
timeFrame: Baseline, SV1 (up to 765 days)
measure: BOTOX® Dose in Patients With "Other" Disorders
timeFrame: Baseline, SV1 (up to 568 days)
measure: Concurrent Procedure Resource Utilization Patterns
timeFrame: Up to 1,785 days
measure: Concurrent Surgical Procedure Resource Utilization Patterns
timeFrame: Up to 1,785 days
Other outcomes:
Locations:
city: Toronto
country: Canada
state: Ontario
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References: