BlepharospasmNCT00535938
MDs on Botox Utility (MOBILITY)
An observational study of Blepharospasm and Torticollis, run by Allergan at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Blepharospasm, Torticollis, Strabismus
- What is being tested?
- botulinum toxin type A
- How many people
- 1,372 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2007to Sep 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Community sample
Who may be able to join
- 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
Who cannot join
- Patient is participating in a clinical trial for any BOTOX® indication
- Patient with any contraindications to use botulinum toxin A
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- botulinum toxin type A
- Medical subject headings
- Blepharospasm, Torticollis, Strabismus, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
botulinum toxin type AOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Naïve to Botox® treatment | Initiating treatment with BOTOX® upon entry to the project. Receives: Other: botulinum toxin type A | |
| Non-naïve to Botox® treatment | Receiving ongoing treatment with BOTOX® upon entry to the project. Receives: Other: botulinum toxin type A |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, SV1 (up to 568 days)
Secondary outcomes (9)
BOTOX® Dose in 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 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.
Measured: Baseline, SV1 (up to 505 days)
BOTOX® Dose in Patients With Blepharospasm
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.
Measured: Baseline, SV1 (up to 542 days)
BOTOX® Dose in Patients With Hyperhidrosis
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.
Measured: Baseline, SV1 (up to 1,273 days)
BOTOX® Dose in Patients With Adult Focal Spasticity
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.
Measured: Baseline, SV1 (up to 1,562 days)
BOTOX® Dose in Patients With Cerebral Palsy
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.
Measured: Baseline, SV1 (up to 925 days)
BOTOX® Dose in Patients With Facial Nerve Disorder
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.
Measured: Baseline, SV1 (up to 765 days)
BOTOX® Dose in 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 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.
Measured: Baseline, SV1 (up to 568 days)
Concurrent Procedure Resource Utilization Patterns
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)
Measured: Up to 1,785 days
Concurrent Surgical Procedure Resource Utilization Patterns
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)
Measured: Up to 1,785 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for BlepharospasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 1,372 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00535938
- Sponsor's protocol ID
- AGN/MMC B00705
- Status last verified
- Sep 2014
- First submitted
- 25 Sep 2007
- Last updated
- 10 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MDs on Botox Utility (MOBILITY)
- ClinicalTrials.gov ID
- NCT00535938
- Acronym / sponsor ID
- AGN/MMC B00705
- Conditions
- Blepharospasm, Torticollis, Strabismus, Muscle Spasticity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,372 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 27 Sep 2007 (estimated)
- Results
- Posted 10 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Naïve to Botox® treatment | – | Other: botulinum toxin type AInitiating treatment with BOTOX® upon entry to the project. |
| Non-naïve to Botox® treatment | – | Other: botulinum toxin type AReceiving ongoing treatment with BOTOX® upon entry to the project. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Community sample
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Patient is participating in a clinical trial for any BOTOX® indication
- Patient with any contraindications to use botulinum toxin A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| botulinum toxin type AThere 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. | Other | Naïve to Botox® treatment, Non-naïve to Botox® treatment |
Primary outcome
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)
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)
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)
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)
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)
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)
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)
"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.
9 secondary outcomes
BOTOX® Dose in Patients With Cervical Dystonia
Time frame: Baseline, SV1 (up to 505 days)
BOTOX® Dose in Patients With Blepharospasm
Time frame: Baseline, SV1 (up to 542 days)
BOTOX® Dose in Patients With Hyperhidrosis
Time frame: Baseline, SV1 (up to 1,273 days)
BOTOX® Dose in Patients With Adult Focal Spasticity
Time frame: Baseline, SV1 (up to 1,562 days)
BOTOX® Dose in Patients With Cerebral Palsy
Time frame: Baseline, SV1 (up to 925 days)
BOTOX® Dose in Patients With Facial Nerve Disorder
Time frame: Baseline, SV1 (up to 765 days)
BOTOX® Dose in Patients With "Other" Disorders
Time frame: Baseline, SV1 (up to 568 days)
Concurrent Procedure Resource Utilization Patterns
Time frame: Up to 1,785 days
Concurrent Surgical Procedure Resource Utilization Patterns
Time frame: Up to 1,785 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Blepharospasm
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RecruitingPhase 4
Effects of DaxibotulinumtoxinA for Blepharospasm and Hemifacial Spasm
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Allergan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blepharospasm and Torticollis, run by Allergan at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2014.