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MDs on Botox Utility (MOBILITY)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00535938
First received: September 25, 2007
Last updated: November 21, 2012
Last verified: November 2012
History of Changes
  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
Blepharospasm
Torticollis
Strabismus
Muscle Spasticity
 Other: botulinum toxin type A

Study Type: Observational
Study Design: Time Perspective: Prospective

Resource links provided by NLM:

MedlinePlus related topics: Botox
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: 1383
Study Start Date: September 2007
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
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, 2012
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Blepharospasm
Muscle Spasticity
Strabismus
Torticollis
Eyelid Diseases
Eye Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Ocular Motility Disorders
Cranial Nerve Diseases
 Dystonic Disorders
Movement Disorders
Central Nervous System Diseases
Dystonia
Dyskinesias
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 June 17, 2013