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ASIS for Botox in Cervical Dy...

ASIS for Botox in Cervical Dystonia

NCT ID: NCT02074293

Last Updated: 2015-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-06-30

Brief Summary

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Botox acts on nerve endings, yet there are no nerve endings inside the muscle, where they are typically injected. All nerves terminate on the fascia, where ASIS device can precisely deliver Botox by creating that subdermal bloodless space, between the skin and muscle. Thus enhancing and prolonging Botox's efficacy, at the same time prevent it's unnecessary adverse reactions and distant spread, especially since Botox has no reason to travel to the rest of the body any way.

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Detailed Description

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Aim 1 over 6 months will demonstrate ASIS device's consistent performance on 60 adult subjects with Cervical Dystonia. Gadolinium will be injected with ASIS subdermally (30) or conventional intramuscularly (30) for these 7 muscle groups: Splenius, Scalene, Sterno-cleido-mastoid, Levator scapulae, Semispinalis, Trapezius, and Longissimus. An MRI will be taken promptly after Gadolinium injection, as starting reference, to which subsequent MRI taken at 6 hrs, 12 hrs, and 24 hrs later will be compared for Persistent %. Since there isn't a way to measure level of Gadolinium within it, or any other (e.g. Botox) for that matter, at least the Prolongation of Gadolinium may be approximated by the greater or longer Persistent % on MRI. However, this approximation can only work if the variables are minimized to the same population with Cervical Dystonia, and these particular 7 muscle groups. Case in point, patients with Cervical Dystonia presumably have hyperactive Splenius, Scalene, Sterno-cleido-mastoid, Levator scapulae, Semispinalis, Trapezius, and Longissimus muscles, so expectantly will have shortened Gadolinium intramuscularly Persistent %, and somewhat reduced Gadolinium subdermally Persistent % as well due to agitation, thus these Persistent % values in Cervical Dystonia patients will not be like those of normal patients, or even the same between these 7 different muscle groups. Therefore, the Relative Prolongation Ability Score or total Persistent % subdermally over total Persistent % intramuscularly, will be specific and valuable indicators to help us modify Botox dosage and duration to inject into "unknown" subdermal bloodless space for Aim 2.

Aim 2 over 12 months, using Botox, instead of Gadolinium, will demonstrate the advantages of ASIS device subdermally over intramuscularly, for the same 60 adult subjects with Cervical Dystonia, on these particular 7 muscle groups: Splenius, Scalene, Sterno-cleido-mastoid, Levator scapulae, Semispinalis, Trapezius, and Longissimus. Hypothetically speaking, if that subdermal bloodless space in patients with e.g., Cervical Dystonia somehow failed to show prolongation of half-life for Gadolinium in Aim 1, we can still proceed with primary interest being therapeutic comparison for Botox in Aim 2, in terms of improvement on the Physician Global Assessment Scale at 6, 12, 18, 24, and 30 weeks, and reduction in Cervical Dystonia Severity Scale (CDSS) as well as adverse reactions.

Conditions

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Cervical Dystonia Adults , Abnormal Head Position and Neck Pain for These 7 Muscle Groups: Splenius,Scalene,Sterno-cleido-mastoid,Levator Scapulae,Semispinalis,Trapezius,and Longissimus.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Splenius

Gadolinium Magnevist® (gadopentetate dimeglumine)

.1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients.

Group Type EXPERIMENTAL

Gadolinium

Intervention Type DRUG

Gadolinium .1cc/ diluted with .9ccNS intramuscularly with ASIS Device for 30 patients. Total cumulative Persistent % of Gadolinium intramuscularly on MRI at 6 hrs, 12 hrs, and 24 hrs.

Gadolinium

Intervention Type DRUG

Gadolinium .1cc/ diluted with .9ccNS subdermally with ASIS Device for 30 patients. Total cumulative Persistent % of Gadolinium subdermally on MRI at 6 hrs, 12 hrs, and 24 hrs.

Gadolinium

Intervention Type DRUG

Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium intramuscularly on MRI.

Scalene

Gadolinium Magnevist® (gadopentetate dimeglumine)

.1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients.

Group Type EXPERIMENTAL

Gadolinium

Intervention Type DRUG

Gadolinium .1cc/ diluted with .9ccNS intramuscularly with ASIS Device for 30 patients. Total cumulative Persistent % of Gadolinium intramuscularly on MRI at 6 hrs, 12 hrs, and 24 hrs.

Gadolinium

Intervention Type DRUG

Gadolinium .1cc/ diluted with .9ccNS subdermally with ASIS Device for 30 patients. Total cumulative Persistent % of Gadolinium subdermally on MRI at 6 hrs, 12 hrs, and 24 hrs.

Gadolinium

Intervention Type DRUG

Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium intramuscularly on MRI.

Sterno-cleido-mastoid

Gadolinium Magnevist® (gadopentetate dimeglumine)

.1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients.

Group Type EXPERIMENTAL

Gadolinium

Intervention Type DRUG

Gadolinium .1cc/ diluted with .9ccNS intramuscularly with ASIS Device for 30 patients. Total cumulative Persistent % of Gadolinium intramuscularly on MRI at 6 hrs, 12 hrs, and 24 hrs.

Gadolinium

Intervention Type DRUG

Gadolinium .1cc/ diluted with .9ccNS subdermally with ASIS Device for 30 patients. Total cumulative Persistent % of Gadolinium subdermally on MRI at 6 hrs, 12 hrs, and 24 hrs.

Gadolinium

Intervention Type DRUG

Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium intramuscularly on MRI.

Levator Scapulae

Gadolinium Magnevist® (gadopentetate dimeglumine)

.1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients.

Group Type EXPERIMENTAL

Gadolinium

Intervention Type DRUG

Gadolinium .1cc/ diluted with .9ccNS intramuscularly with ASIS Device for 30 patients. Total cumulative Persistent % of Gadolinium intramuscularly on MRI at 6 hrs, 12 hrs, and 24 hrs.

Gadolinium

Intervention Type DRUG

Gadolinium .1cc/ diluted with .9ccNS subdermally with ASIS Device for 30 patients. Total cumulative Persistent % of Gadolinium subdermally on MRI at 6 hrs, 12 hrs, and 24 hrs.

Gadolinium

Intervention Type DRUG

Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium intramuscularly on MRI.

Semispinalis

Gadolinium Magnevist® (gadopentetate dimeglumine)

.1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients.

Group Type EXPERIMENTAL

Gadolinium

Intervention Type DRUG

Gadolinium .1cc/ diluted with .9ccNS intramuscularly with ASIS Device for 30 patients. Total cumulative Persistent % of Gadolinium intramuscularly on MRI at 6 hrs, 12 hrs, and 24 hrs.

Gadolinium

Intervention Type DRUG

Gadolinium .1cc/ diluted with .9ccNS subdermally with ASIS Device for 30 patients. Total cumulative Persistent % of Gadolinium subdermally on MRI at 6 hrs, 12 hrs, and 24 hrs.

Gadolinium

Intervention Type DRUG

Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium intramuscularly on MRI.

Trapezius

Gadolinium Magnevist® (gadopentetate dimeglumine)

.1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients.

Group Type EXPERIMENTAL

Gadolinium

Intervention Type DRUG

Gadolinium .1cc/ diluted with .9ccNS intramuscularly with ASIS Device for 30 patients. Total cumulative Persistent % of Gadolinium intramuscularly on MRI at 6 hrs, 12 hrs, and 24 hrs.

Gadolinium

Intervention Type DRUG

Gadolinium .1cc/ diluted with .9ccNS subdermally with ASIS Device for 30 patients. Total cumulative Persistent % of Gadolinium subdermally on MRI at 6 hrs, 12 hrs, and 24 hrs.

Gadolinium

Intervention Type DRUG

Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium intramuscularly on MRI.

Longissimus

Gadolinium Magnevist® (gadopentetate dimeglumine)

.1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients.

Group Type EXPERIMENTAL

Gadolinium

Intervention Type DRUG

Gadolinium .1cc/ diluted with .9ccNS intramuscularly with ASIS Device for 30 patients. Total cumulative Persistent % of Gadolinium intramuscularly on MRI at 6 hrs, 12 hrs, and 24 hrs.

Gadolinium

Intervention Type DRUG

Gadolinium .1cc/ diluted with .9ccNS subdermally with ASIS Device for 30 patients. Total cumulative Persistent % of Gadolinium subdermally on MRI at 6 hrs, 12 hrs, and 24 hrs.

Gadolinium

Intervention Type DRUG

Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium intramuscularly on MRI.

Change from Baseline in Pain Frequency

Change from Baseline in Pain Frequency as Efficacy of Botox intramuscularly at Week 6, Efficacy of Botox intramuscularly at Week 12, Efficacy of Botox intramuscularly at Week 18, Efficacy of Botox intramuscularly at Week 24, and Efficacy of Botox intramuscularly at Week 30 vs.Efficacy of Botox subdermally at Week 6, Efficacy of Botox subdermally at Week 12, Efficacy of Botox subdermally at Week 18, Efficacy of Botox subdermally at Week 24, and Efficacy of Botox subdermally at Week 30.

Group Type EXPERIMENTAL

Efficacy of Botox intramuscularly at Week 6

Intervention Type DRUG

Efficacy of Botox (onabotulinumtoxinA) intramuscularly at Week 6, in terms of improvement on the Physician Global Assessment Scale, and Change from Baseline in Pain Frequency, and Pain Intensity, as well as Cervical Dystonia Severity Scale (CDSS).

Efficacy of Botox intramuscularly at Week 12

Intervention Type DRUG

Efficacy of Botox intramuscularly at Week 12, in terms of Percent of Patients with Improved PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Pain Frequency, Change from Baseline in Pain Intensity, Change from Baseline in CDSS (Cervical Dystonia Severity Scale).

Efficacy of Botox intramuscularly at Week 18

Intervention Type DRUG

Efficacy of Botox intramuscularly at Week 18, in terms of Percent of Patients with Improved PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Pain Frequency, Change from Baseline in Pain Intensity, Change from Baseline in CDSS (Cervical Dystonia Severity Scale).

Efficacy of Botox intramuscularly at Week 24

Intervention Type DRUG

Efficacy of Botox (onabotulinumtoxinA) intramuscularly at Week 24, in terms of improvement on the Physician Global Assessment Scale, and Change from Baseline in Pain Frequency, and Pain Intensity, as well as Cervical Dystonia Severity Scale (CDSS).

Efficacy of Botox intramuscularly at Week 30

Intervention Type DRUG

Efficacy of Botox (onabotulinumtoxinA) intramuscularly at Week 30, in terms of improvement on the Physician Global Assessment Scale, and Change from Baseline in Pain Frequency, and Pain Intensity, as well as Cervical Dystonia Severity Scale (CDSS).

Efficacy of Botox subdermally at Week 6

Intervention Type DRUG

Efficacy of Botox (onabotulinumtoxinA) subdermally at Week 6, in terms of improvement on the Physician Global Assessment Scale, and Change from Baseline in Pain Frequency, and Pain Intensity, as well as Cervical Dystonia Severity Scale (CDSS).

Efficacy of Botox subdermally at Week 12

Intervention Type DRUG

Efficacy of Botox (onabotulinumtoxinA) subdermally at Week 12, in terms of improvement on the Physician Global Assessment Scale, and Change from Baseline in Pain Frequency, and Pain Intensity, as well as Cervical Dystonia Severity Scale (CDSS).

Efficacy of Botox subdermally at Week 18

Intervention Type DRUG

Efficacy of Botox (onabotulinumtoxinA) subdermally at Week 18, in terms of improvement on the Physician Global Assessment Scale, and Change from Baseline in Pain Frequency, and Pain Intensity, as well as Cervical Dystonia Severity Scale (CDSS).

Efficacy of Botox subdermally at Week 24

Intervention Type DRUG

Efficacy of Botox (onabotulinumtoxinA) subdermally at Week 24, in terms of improvement on the Physician Global Assessment Scale, and Change from Baseline in Pain Frequency, and Pain Intensity, as well as Cervical Dystonia Severity Scale (CDSS).

Efficacy of Botox subdermally at Week 30

Intervention Type DRUG

Efficacy of Botox (onabotulinumtoxinA) subdermally at Week 30, in terms of improvement on the Physician Global Assessment Scale, and Change from Baseline in Pain Frequency, and Pain Intensity, as well as Cervical Dystonia Severity Scale (CDSS).

Change from Baseline in Pain Intensity

Change from Baseline in Pain Intensity as Efficacy of Botox intramuscularly at Week 6, Efficacy of Botox intramuscularly at Week 12, Efficacy of Botox intramuscularly at Week 18, Efficacy of Botox intramuscularly at Week 24, and Efficacy of Botox intramuscularly at Week 30 vs.Efficacy of Botox subdermally at Week 6, Efficacy of Botox subdermally at Week 12, Efficacy of Botox subdermally at Week 18, Efficacy of Botox subdermally at Week 24, and Efficacy of Botox subdermally at Week 30. The severity on scales of 0(no pain) to 4(constant or extremely severe intensity).

Group Type EXPERIMENTAL

Efficacy of Botox intramuscularly at Week 6

Intervention Type DRUG

Efficacy of Botox intramuscularly at Week 12

Intervention Type DRUG

Efficacy of Botox intramuscularly at Week 18

Intervention Type DRUG

Efficacy of Botox intramuscularly at Week 24

Intervention Type DRUG

Efficacy of Botox intramuscularly at Week 30

Intervention Type DRUG

Efficacy of Botox subdermally at Week 6

Intervention Type DRUG

Efficacy of Botox subdermally at Week 12

Intervention Type DRUG

Efficacy of Botox subdermally at Week 18

Intervention Type DRUG

Efficacy of Botox subdermally at Week 24

Intervention Type DRUG

Efficacy of Botox subdermally at Week 30

Intervention Type DRUG

Change from Baseline in CDSS

Change from Baseline in CDSS as Efficacy of Botox intramuscularly at Week 6, Efficacy of Botox intramuscularly at Week 12, Efficacy of Botox intramuscularly at Week 18, Efficacy of Botox intramuscularly at Week 24, and Efficacy of Botox intramuscularly at Week 30 vs.Efficacy of Botox subdermally at Week 6, Efficacy of Botox subdermally at Week 12, Efficacy of Botox subdermally at Week 18, Efficacy of Botox subdermally at Week 24, and Efficacy of Botox subdermally at Week 30. The CDSS or Cervical Dystonia Severity Scale quantifies the severity of abnormal head positioning and was newly devised for this study. CDSS allots 1 point for each 5 degrees (or part thereof) of head deviation in each of the three planes of head movement (range of scores up to theoretical maximum of 54).

Group Type EXPERIMENTAL

Efficacy of Botox intramuscularly at Week 6

Intervention Type DRUG

Efficacy of Botox intramuscularly at Week 12

Intervention Type DRUG

Efficacy of Botox intramuscularly at Week 18

Intervention Type DRUG

Efficacy of Botox intramuscularly at Week 24

Intervention Type DRUG

Efficacy of Botox intramuscularly at Week 30

Intervention Type DRUG

Efficacy of Botox subdermally at Week 6

Intervention Type DRUG

Efficacy of Botox subdermally at Week 12

Intervention Type DRUG

Efficacy of Botox subdermally at Week 18

Intervention Type DRUG

Efficacy of Botox subdermally at Week 24

Intervention Type DRUG

Efficacy of Botox subdermally at Week 30

Intervention Type DRUG

Percent of Patients with Improved PGAS

Percent of Patients with Improved PGAS as Efficacy of Botox intramuscularly at Week 6, Efficacy of Botox intramuscularly at Week 12, Efficacy of Botox intramuscularly at Week 18, Efficacy of Botox intramuscularly at Week 24, and Efficacy of Botox intramuscularly at Week 30 vs.Efficacy of Botox subdermally at Week 6, Efficacy of Botox subdermally at Week 12, Efficacy of Botox subdermally at Week 18, Efficacy of Botox subdermally at Week 24, and Efficacy of Botox subdermally at Week 30. The Physician Global Assessment Scale or PGAS is a 9 category scale scoring the physician's evaluation of the patients' status compared to baseline, ranging from -4 to +4 (very marked worsening to complete improvement), with 0 indicating no change from baseline and +1 slight improvement.

Group Type EXPERIMENTAL

Efficacy of Botox intramuscularly at Week 6

Intervention Type DRUG

Efficacy of Botox intramuscularly at Week 12

Intervention Type DRUG

Efficacy of Botox intramuscularly at Week 18

Intervention Type DRUG

Efficacy of Botox intramuscularly at Week 24

Intervention Type DRUG

Efficacy of Botox intramuscularly at Week 30

Intervention Type DRUG

Efficacy of Botox subdermally at Week 6

Intervention Type DRUG

Efficacy of Botox subdermally at Week 12

Intervention Type DRUG

Efficacy of Botox subdermally at Week 18

Intervention Type DRUG

Efficacy of Botox subdermally at Week 24

Intervention Type DRUG

Efficacy of Botox subdermally at Week 30

Intervention Type DRUG

Adverse Reactions with Facial paresis

Facial paresis as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.

Group Type EXPERIMENTAL

Adverse Reactions of Botox intramuscularly

Intervention Type DRUG

Adverse Reactions of Botox (onabotulinumtoxinA) intramuscularly at Week 30, in number of Headache Migraine, Facial paresis, Eyelid ptosis, Bronchitis, Neck pain Musculoskeletal stiffness, Muscular weakness Myalgia, Musculoskeletal pain, Muscle spasms, Injection site pain, and Hypertension.

Adverse Reactions of Botox subdermally

Intervention Type DRUG

Adverse Reactions of Botox (onabotulinumtoxinA) subdermally at Week 30, in number of Headache Migraine, Facial paresis, Eyelid ptosis, Bronchitis, Neck pain Musculoskeletal stiffness, Muscular weakness Myalgia, Musculoskeletal pain, Muscle spasms, Injection site pain, and Hypertension.

Adverse Reactions with Eyelid ptosis

Eyelid ptosis as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.

Group Type EXPERIMENTAL

Adverse Reactions of Botox intramuscularly

Intervention Type DRUG

Adverse Reactions of Botox subdermally

Intervention Type DRUG

Adverse Reactions with Bronchitis

Bronchitis as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.

Group Type EXPERIMENTAL

Adverse Reactions of Botox intramuscularly

Intervention Type DRUG

Adverse Reactions of Botox subdermally

Intervention Type DRUG

Adverse Reactions with Neck pain

Neck pain as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.

Group Type EXPERIMENTAL

Adverse Reactions of Botox intramuscularly

Intervention Type DRUG

Adverse Reactions of Botox subdermally

Intervention Type DRUG

Adverse Reactions with Muscle stiffness

Musculoskeletal stiffness as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.

Group Type EXPERIMENTAL

Adverse Reactions of Botox intramuscularly

Intervention Type DRUG

Adverse Reactions of Botox subdermally

Intervention Type DRUG

Adverse Reactions with Muscular weakness

Muscular weakness as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.

Group Type EXPERIMENTAL

Adverse Reactions of Botox intramuscularly

Intervention Type DRUG

Adverse Reactions of Botox subdermally

Intervention Type DRUG

Adverse Reactions with Myalgia

Myalgia as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.

Group Type EXPERIMENTAL

Adverse Reactions of Botox intramuscularly

Intervention Type DRUG

Adverse Reactions of Botox subdermally

Intervention Type DRUG

Adverse Reactions with Muscle pain

Musculoskeletal pain as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.

Group Type EXPERIMENTAL

Adverse Reactions of Botox intramuscularly

Intervention Type DRUG

Adverse Reactions of Botox subdermally

Intervention Type DRUG

Adverse Reactions with Muscle spasms

Muscle spasms as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.

Group Type EXPERIMENTAL

Adverse Reactions of Botox intramuscularly

Intervention Type DRUG

Adverse Reactions of Botox subdermally

Intervention Type DRUG

Adverse Reactions Injection site pain

Injection site pain as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.

Group Type EXPERIMENTAL

Adverse Reactions of Botox intramuscularly

Intervention Type DRUG

Adverse Reactions of Botox subdermally

Intervention Type DRUG

Adverse Reactions with Hypertension

Hypertension as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.

Group Type EXPERIMENTAL

Adverse Reactions of Botox intramuscularly

Intervention Type DRUG

Adverse Reactions of Botox subdermally

Intervention Type DRUG

Interventions

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Gadolinium

Gadolinium .1cc/ diluted with .9ccNS intramuscularly with ASIS Device for 30 patients. Total cumulative Persistent % of Gadolinium intramuscularly on MRI at 6 hrs, 12 hrs, and 24 hrs.

Intervention Type DRUG

Gadolinium

Gadolinium .1cc/ diluted with .9ccNS subdermally with ASIS Device for 30 patients. Total cumulative Persistent % of Gadolinium subdermally on MRI at 6 hrs, 12 hrs, and 24 hrs.

Intervention Type DRUG

Gadolinium

Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium intramuscularly on MRI.

Intervention Type DRUG

Efficacy of Botox intramuscularly at Week 6

Intervention Type DRUG

Efficacy of Botox intramuscularly at Week 12

Intervention Type DRUG

Efficacy of Botox intramuscularly at Week 18

Intervention Type DRUG

Efficacy of Botox intramuscularly at Week 24

Intervention Type DRUG

Efficacy of Botox intramuscularly at Week 30

Intervention Type DRUG

Efficacy of Botox subdermally at Week 6

Intervention Type DRUG

Efficacy of Botox subdermally at Week 12

Intervention Type DRUG

Efficacy of Botox subdermally at Week 18

Intervention Type DRUG

Efficacy of Botox subdermally at Week 24

Intervention Type DRUG

Efficacy of Botox subdermally at Week 30

Intervention Type DRUG

Adverse Reactions of Botox intramuscularly

Intervention Type DRUG

Adverse Reactions of Botox subdermally

Intervention Type DRUG

Other Intervention Names

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Gadolinium Magnevist® (gadopentetate dimeglumine) Gadolinium Magnevist® (gadopentetate dimeglumine) Gadolinium Magnevist® (gadopentetate dimeglumine) Botox (onabotulinumtoxinA) Botox (onabotulinumtoxinA) Botox (onabotulinumtoxinA) Botox (onabotulinumtoxinA) Botox (onabotulinumtoxinA) Botox (onabotulinumtoxinA) Botox (onabotulinumtoxinA) Botox (onabotulinumtoxinA) Botox (onabotulinumtoxinA) Botox (onabotulinumtoxinA) Botox (onabotulinumtoxinA) Botox (onabotulinumtoxinA)

Eligibility Criteria

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Inclusion Criteria

•Adults with cervical dystonia, or abnormal head position and neck pain for these 7 muscle groups: Splenius, Scalene, Sterno-cleido-mastoid, Levator scapulae, Semispinalis, Trapezius, and Longissimus.

Exclusion Criteria

* Known Hypersensitivity to Botulinum Toxin or to any of the components in the formulation.
* Infection at the Injection Site(s).
* Has any medical condition that may increase their risk with exposure to Botox including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interfere with neuromuscular function.
* Has profound atrophy or weakness of muscles in the target areas of injection.
* Had previously received surgical or other denervation treatment for their symptoms or had a known history of neuromuscular disorder.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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li nguyen

MD/CEO/PI

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Automatic Subdermal Injector System, Inc

Westminster, California, United States

Site Status

Countries

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United States

Central Contacts

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Li Nguyen, MD

Role: CONTACT

[email protected]

(714)-453-7857

Thanh Phung, MD

Role: CONTACT

[email protected]

714-893-1915

Facility Contacts

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Li Nguyen, MD

Role: primary

[email protected]

714-453-7857

Thanh Phung, MD

Role: backup

[email protected]

(714)-893-1915

References

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Lorenc ZP, Kenkel JM, Fagien S, Hirmand H, Nestor MS, Sclafani AP, Sykes JM, Waldorf HA. A review of onabotulinumtoxinA (Botox). Aesthet Surg J. 2013 Mar;33(1 Suppl):9S-12S. doi: 10.1177/1090820X12474629.

Reference Type BACKGROUND

PMID: 23515199 (View on PubMed)

Knopp MV, Balzer T, Esser M, Kashanian FK, Paul P, Niendorf HP. Assessment of utilization and pharmacovigilance based on spontaneous adverse event reporting of gadopentetate dimeglumine as a magnetic resonance contrast agent after 45 million administrations and 15 years of clinical use. Invest Radiol. 2006 Jun;41(6):491-9. doi: 10.1097/01.rli.0000209657.16115.42.

Reference Type BACKGROUND

PMID: 16763467 (View on PubMed)

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Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R44NS089268

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NCTNS089268

Identifier Type: -

Identifier Source: org_study_id

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