MDs on Botox Utility (MOBILITY)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00535938
First received: September 25, 2007
Last updated: September 4, 2014
Last verified: September 2014
  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:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Cervical Dystonia [ Time Frame: Baseline, SV1 (up to 505 days) ] [ Designated as safety issue: No ]
    Cervical dystonia is a condition in which the neck muscles contract involuntarily, causing the head to turn to one side, forward or backward. The SF-12 consists of 12 questions on various health questions. Health utility is a numerical indicator of a person's preferences for a given health state or health outcome. Health utility is a sub-score ranging from 0 (death) to 1 (perfect health) and is calculated from the SF-12 total score based on the following items: physical functioning, role participation, social functioning, bodily pain, mental health, and vitality and is termed SF-6D. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician's discretion and was a maximum of 505 days for patients with cervical dystonia.

  • Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Blepharospasm [ Time Frame: Baseline, SV1 (up to 542 days) ] [ Designated as safety issue: No ]
    Blepharospasm is a condition in which the eyelids blink/close involuntarily. The SF-12 consists of 12 questions on various health questions. Health utility is a numerical indicator of a person's preferences for a given health state or health outcome. Health utility is a sub-score ranging from 0 (death) to 1 (perfect health) and is calculated from the SF-12 total score based on the following items: physical functioning, role participation, social functioning, bodily pain, mental health, and vitality and is termed SF-6D. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician's discretion and was a maximum of 542 days for patients with blepharospasm.

  • Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Hyperhidrosis [ Time Frame: Baseline, SV1 (up to 1,273 days) ] [ Designated as safety issue: No ]
    Hyperhidrosis is a condition causing excessive sweating, regardless of temperature or exercise. The SF-12 consists of 12 questions on various health questions. Health utility is a numerical indicator of a person's preferences for a given health state or health outcome. Health utility is a sub-score ranging from 0 (death) to 1 (perfect health) and is calculated from the SF-12 total score based on the following items: physical functioning, role participation, social functioning, bodily pain, mental health, and vitality and is termed SF-6D. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician's discretion and was a maximum of 1,273 days for patients with hyperhidrosis.

  • Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Cerebral Palsy [ Time Frame: Baseline, SV1 (up to 925 days) ] [ Designated as safety issue: No ]
    Cerebral Palsy is a disability resulting in muscular incoordination and speech disturbances. The SF-12 consists of 12 questions on various health questions. Health utility is a numerical indicator of a person's preferences for a given health state or health outcome. Health utility is a sub-score ranging from 0 (death) to 1 (perfect health) and is calculated from the SF-12 total score based on the following items: physical functioning, role participation, social functioning, bodily pain, mental health, and vitality and is termed SF-6D. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician's discretion and was a maximum of 925 days for patients with cerebral palsy.

  • 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 [ Time Frame: Baseline, SV1 (up to 1,562 days) ] [ Designated as safety issue: No ]
    Adult Focal Spasticity is a condition in which muscles are continuously tight or stiff in a certain area. The SF-12 consists of 12 questions on various health questions. Health utility is a numerical indicator of a person's preferences for a given health state or health outcome. Health utility is a sub-score ranging from 0 (death) to 1 (perfect health) and is calculated from the SF-12 total score based on the following items: physical functioning, role participation, social functioning, bodily pain, mental health, and vitality and is termed SF-6D. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician's discretion and was a maximum of 1,562 days for patients with adult focal spasticity.

  • 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 [ Time Frame: Baseline, SV1 (up to 765 days) ] [ Designated as safety issue: No ]
    Facial nerve disorder is a condition causing twitching, weakness or paralysis of the face. The SF-12 consists of 12 questions on various health questions. Health utility is a numerical indicator of a person's preferences for a given health state or health outcome. Health utility is a sub-score ranging from 0 (death) to 1 (perfect health) and is calculated from the SF-12 total score based on the following items: physical functioning, role participation, social functioning, bodily pain, mental health, and vitality and is termed SF-6D. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician's discretion and was a maximum of 765 days for patients with facial nerve disorder.

  • Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With "Other" Disorders [ Time Frame: Baseline, SV1 (up to 568 days) ] [ Designated as safety issue: No ]
    "Other" disorders include focal dystonia (involuntary muscular contractions/abnormal postures), headache, pain, tics (sudden, repetitive, nonrhythmic movements/vocalizations), tremors (unintentional, rhythmic muscle movements), and other nonspecified disorders. The SF-12 is 12 questions on various health questions. Health utility is a numerical indicator of a person's preference for a given health state or health outcome. Health utility is a sub-score ranging from 0(death) to 1(perfect health) calculated from the SF-12 total score based on: physical functioning, role participation, social functioning, bodily pain, mental health, and vitality and is termed SF-6D. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. The length of time between Baseline and SV1 is scheduled at the physician's discretion and was a maximum of 568 days for patients with "other" disorders.


Secondary Outcome Measures:
  • BOTOX® Dose in Patients With Cervical Dystonia [ Time Frame: Baseline, SV1 (up to 505 days) ] [ Designated as safety issue: No ]
    Cervical dystonia is a condition in which the neck muscles contract involuntarily, causing the head to turn to one side, forward or backward. The BOTOX® dose was assessed in this patient population. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician's discretion and was a maximum of 505 days for patients with cervical dystonia.

  • BOTOX® Dose in Patients With Blepharospasm [ Time Frame: Baseline, SV1 (up to 542 days) ] [ Designated as safety issue: No ]
    Blepharospasm is a condition in which the eyelids blink/close involuntarily. The BOTOX® dose was assessed in this patient population. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician's discretion and was a maximum of 542 days for patients with blepharospasm.

  • BOTOX® Dose in Patients With Hyperhidrosis [ Time Frame: Baseline, SV1 (up to 1,273 days) ] [ Designated as safety issue: No ]
    Hyperhidrosis is a condition causing excessive sweating, regardless of temperature or exercise. The BOTOX® dose was assessed in this patient population. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician's discretion and was a maximum of 1,273 days for patients with hyperhidrosis.

  • BOTOX® Dose in Patients With Adult Focal Spasticity [ Time Frame: Baseline, SV1 (up to 1,562 days) ] [ Designated as safety issue: No ]
    Adult Focal Spasticity is a condition in which muscles are continuously tight or stiff in a certain area. The BOTOX® dose was assessed in this patient population. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician's discretion and was a maximum of 1,562 days for patients with adult focal spasticity.

  • BOTOX® Dose in Patients With Cerebral Palsy [ Time Frame: Baseline, SV1 (up to 925 days) ] [ Designated as safety issue: No ]
    Cerebral Palsy is a disability resulting in muscular incoordination and speech disturbances. The BOTOX® dose was assessed in this patient population. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician's discretion and was a maximum of 925 days for patients with cerebral palsy.

  • BOTOX® Dose in Patients With Facial Nerve Disorder [ Time Frame: Baseline, SV1 (up to 765 days) ] [ Designated as safety issue: No ]
    Facial nerve disorder is a condition causing twitching, weakness or paralysis of the face. The BOTOX® dose was assessed in this patient population. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician's discretion and was a maximum of 765 days for patients with facial nerve disorder.

  • BOTOX® Dose in Patients With "Other" Disorders [ Time Frame: Baseline, SV1 (up to 568 days) ] [ Designated as safety issue: No ]
    "Other" disorders include focal dystonia (involuntary muscular contractions/abnormal postures), headache, pain, tics (sudden, repetitive, nonrhythmic movements/vocalizations), tremors (unintentional, rhythmic muscle movements), and other nonspecified disorders. The BOTOX® dose was assessed in this patient population. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician's discretion and was a maximum of 568 days for patients with "other" disorders.

  • Concurrent Procedure Resource Utilization Patterns [ Time Frame: Up to 1,785 days ] [ Designated as safety issue: No ]
    Resource utilization patterns are assessed in terms of concurrent procedures utilized during the study (up to 1,785 days across all indications) and are grouped by highest level term. (Note: NEC=not elsewhere classified)

  • Concurrent Surgical Procedure Resource Utilization Patterns [ Time Frame: Up to 1,785 days ] [ Designated as safety issue: No ]
    Resource utilization patterns are assessed in terms of concurrent surgical procedures utilized during the study (up to 1,785 days across all indications) and are grouped by highest level term. (Note: NEC=not elsewhere classified)


Enrollment: 1372
Study Start Date: September 2007
Study Completion Date: September 2013
Primary Completion Date: September 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Results First Received: September 4, 2014
Last Updated: September 4, 2014
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
Botulinum Toxins, Type A
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 30, 2014