MDs on Botox Utility (MOBILITY)

NCT ID: NCT00535938

Last Updated: 2014-09-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1372 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-09-30

Study Completion Date

2013-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Blepharospasm Torticollis Strabismus Muscle Spasticity

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Naïve to Botox® treatment

Initiating treatment with BOTOX® upon entry to the project.

botulinum toxin type A

Intervention Type OTHER

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.

Non-naïve to Botox® treatment

Receiving ongoing treatment with BOTOX® upon entry to the project.

botulinum toxin type A

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

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Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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AGN/MMC B00705

Identifier Type: -

Identifier Source: org_study_id

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