MDs on Botox Utility (MOBILITY)

NCT00535938 | Completed Results

• 1 other identifier: AGN/MMC B00705
• Study Type: observational
• Target: 1,372
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Blepharospasm; Torticollis; Strabismus; Muscle Spasticity

Outcome Measures

Primary Outcomes (7)

• Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Cervical Dystonia

  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.

  Baseline, SV1 (up to 505 days)

• Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Blepharospasm

  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.

  Baseline, SV1 (up to 542 days)

• Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Hyperhidrosis

  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.

  Baseline, SV1 (up to 1,273 days)

• Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Cerebral Palsy

  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.

  Baseline, SV1 (up to 925 days)

• 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

  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.

  Baseline, SV1 (up to 1,562 days)

• 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

  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.

  Baseline, SV1 (up to 765 days)

• Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With "Other" Disorders

  "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.

  Baseline, SV1 (up to 568 days)

Secondary Outcomes (9)

• BOTOX® Dose in Patients With Cervical Dystonia

  Baseline, SV1 (up to 505 days)

• BOTOX® Dose in Patients With Blepharospasm

  Baseline, SV1 (up to 542 days)

• BOTOX® Dose in Patients With Hyperhidrosis

  Baseline, SV1 (up to 1,273 days)

• BOTOX® Dose in Patients With Adult Focal Spasticity

  Baseline, SV1 (up to 1,562 days)

• BOTOX® Dose in Patients With Cerebral Palsy

  Baseline, SV1 (up to 925 days)

Study Arms (2)

Naïve to Botox® treatment

Initiating treatment with BOTOX® upon entry to the project.

Other: botulinum toxin type A

Non-naïve to Botox® treatment

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

Other: botulinum toxin type A

Interventions

botulinum toxin type A 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.

Naïve to Botox® treatment; Non-naïve to Botox® treatment

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community sample

You may qualify if:

• 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

You may not qualify if:

• Patient is participating in a clinical trial for any BOTOX® indication
• Patient with any contraindications to use botulinum toxin A

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Blepharospasm; Torticollis; Strabismus; Muscle Spasticity

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases; Dystonia; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Ocular Motility Disorders; Cranial Nerve Diseases; Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Results Point of Contact

• Title: Vice President Medical Affairs,
• Organization: Allergan, Inc

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2007
• First Posted: September 27, 2007
• Study Start: September 1, 2007
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: September 10, 2014
• Results First Posted: September 10, 2014

Record last verified: 2014-09

Locations

CA (1)