MDs on Botox Utility (MOBILITY) - Full Text View

Sponsor:	Allergan
Information provided by (Responsible Party):	Allergan
ClinicalTrials.gov Identifier:	NCT00535938

Purpose

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.

Condition	Intervention
Patients Treated With BOTOX® for On-label Therapeutic Indications	Other: botulinum toxin type A

Study Type:	Observational
Study Design:	Time Perspective: Prospective

Resource links provided by NLM:

MedlinePlus related topics: Botox

Drug Information available for: Botulinum toxin A Clostridium botulinum toxin

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:

Measure Health Utility (quality of life) by using the SF-12® Health Survey Scores and the SF-6D [ Time Frame: Baseline, week 4; subsequent injection visit as determined by MD ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]
Characterize patient experience and physician treatment patterns with BOTOX® [ Time Frame: Baseline, Subsequent injection visits (time interval determined by MD) ] [ Designated as safety issue: No ]
Resource utilization [ Time Frame: Baseline, Subsequent injection visits (time interval determined by MD) ] [ Designated as safety issue: No ]

Enrollment:	1364
Study Start Date:	September 2007
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1) naïve to Botox® treatment Initiating treatment with BOTOX® upon entry to the project	Other: botulinum toxin type A There will be no protocol-mandated intervention with regard to physician treatment choice or management of patient condition once the patient is enrolled in the project.
2) Non-naïve to Botox® treatment Receiving ongoing treatment with BOTOX® upon entry to the project.	Other: botulinum toxin type A There will be no protocol-mandated intervention with regard to physician treatment choice or management of patient condition once the patient is enrolled in the project.

Eligibility

Ages Eligible for Study:	14 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Community sample

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00535938

Locations

Canada, Ontario

Toronto, Ontario, Canada

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Director

Allergan

More Information

No publications provided

Responsible Party:	Allergan
ClinicalTrials.gov Identifier:	NCT00535938 History of Changes
Other Study ID Numbers:	AGN/MMC B00705
Study First Received:	September 25, 2007
Last Updated:	November 21, 2011
Health Authority:	Canada: Health Canada

Additional relevant MeSH terms:

Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012