MDs on Botox Utility (MOBILITY)

Condition(s) targeted: Patients Treated With BOTOX® for on-Label Therapeutic Indications

Intervention: botulinum toxin type A (Other)

Phase: N/A

Status: Recruiting

Sponsored by: Allergan

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Allergan

Overall contact:
Allergan Inc, Email: clinicaltrials@allergan.com

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.

Study design: Other, Prospective

Primary outcome: Measure Health Utility (quality of life) by using the SF-12® Health Survey Scores and the SF-6D

Secondary outcome:

Measure the change in utility from baseline and determine the Minimally Important Difference (MID) by using the utility and GRC (global rating of change) scores

Measure the Physical and Mental Component Summary scores (PCS and MCS) and assess changes in PCS and MCS from baseline in the naïve patient group

Characterize patient experience and physician treatment patterns with BOTOX®

Resource utilization

Minimum age: 14 Years. Maximum age: N/A. Gender(s): Both.

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

Allergan Inc, Email: clinicaltrials@allergan.com

Toronto, Ontario, Canada; Recruiting

Starting date: September 2007
Ending date: December 2013
Last updated: September 22, 2008