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ASIS for Botox in Cervical Dystonia (ASISinCD)

Primary Purpose

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.

Status

Unknown status

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Gadolinium

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

Efficacy of Botox intramuscularly at Week 30

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

Efficacy of Botox subdermally at Week 30

Adverse Reactions of Botox intramuscularly

Adverse Reactions of Botox subdermally

About this trial

This is an interventional treatment trial for Cervical Dystonia Adults , focused on measuring Subdermal bloodless space, Subdermal injection, injectable EMG needle, electrical stimulation, MRI with Gadolinium, Cervical Dystonia, intramuscular injection, cervical dystonia,

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Automatic Subdermal Injector System, Inc

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm 16

Arm 17

Arm 18

Arm 19

Arm 20

Arm 21

Arm 22

Arm Type

Experimental

Arm Label

Splenius

Scalene

Sterno-cleido-mastoid

Levator Scapulae

Semispinalis

Trapezius

Longissimus

Change from Baseline in Pain Frequency

Change from Baseline in Pain Intensity

Change from Baseline in CDSS

Percent of Patients with Improved PGAS

Adverse Reactions with Facial paresis

Adverse Reactions with Eyelid ptosis

Adverse Reactions with Bronchitis

Adverse Reactions with Neck pain

Adverse Reactions with Muscle stiffness

Adverse Reactions with Muscular weakness

Adverse Reactions with Myalgia

Adverse Reactions with Muscle pain

Adverse Reactions with Muscle spasms

Adverse Reactions Injection site pain

Adverse Reactions with Hypertension

Arm Description

Gadolinium Magnevist® (gadopentetate dimeglumine) .1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients.

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.

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).

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).

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.

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

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

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

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

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

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

Relative Prolongation Ability Score for Gadolinium subdermally injected.

Gadolinium will be injected with ASIS subdermally (30) or conventional intramuscularly (30) in Cervical Dystonia adult patients 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 %. This approximation can only work if the variables are minimized to the same population with Cervical Dystonia, and these particular 7 muscle groups. The Relative Prolongation Ability Score or total Persistent % subdermally over total Persistent % intramuscularly, in Cervical Dystonia patients will not be like those of normal patients, or even the same between these 7 different muscle groups, but valuable indicators to help us modify Botox dosage and duration to inject into "unknown" subdermal bloodless space for Aim 2.

Secondary Outcome Measures

Efficacy of Botox intramuscularly vs. subdermally in Cervical Dystonia.

Efficacy of Botox intramuscularly vs. subdermally with ASIS Device at Week 6,12,18, 24, and 30; in terms of improvement on the Physician Global Assessment Scale (-4=very marked worsening to +4=very marked improvement). Also in terms of improvement, or Median Change from Baseline in Pain Frequency, Pain Intensity (0(no pain) to 4(constant or extremely severe intensity)), and Cervical Dystonia Severity Scale (CDSS). 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).

Full Information

NCT ID

NCT02074293

First Posted

February 26, 2014

Last Updated

June 22, 2015

Sponsor

li nguyen

1. Study Identification

Unique Protocol Identification Number

NCT02074293

Brief Title

ASIS for Botox in Cervical Dystonia

Acronym

ASISinCD

Official Title

ASIS for Botox in Cervical Dystonia

Study Type

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Unknown status

Study Start Date

January 2016 (undefined)

Primary Completion Date

June 2016 (Anticipated)

Study Completion Date

June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

li nguyen

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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.

Keywords

Subdermal bloodless space, Subdermal injection, injectable EMG needle, electrical stimulation, MRI with Gadolinium, Cervical Dystonia, intramuscular injection, cervical dystonia,

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Splenius

Arm Type

Experimental

Arm Description

Gadolinium Magnevist® (gadopentetate dimeglumine) .1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients.

Arm Title

Scalene

Arm Type

Experimental

Arm Description

Gadolinium Magnevist® (gadopentetate dimeglumine) .1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients.

Arm Title

Sterno-cleido-mastoid

Arm Type

Experimental

Arm Description

Gadolinium Magnevist® (gadopentetate dimeglumine) .1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients.

Arm Title

Levator Scapulae

Arm Type

Experimental

Arm Description

Gadolinium Magnevist® (gadopentetate dimeglumine) .1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients.

Arm Title

Semispinalis

Arm Type

Experimental

Arm Description

Gadolinium Magnevist® (gadopentetate dimeglumine) .1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients.

Arm Title

Trapezius

Arm Type

Experimental

Arm Description

Gadolinium Magnevist® (gadopentetate dimeglumine) .1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients.

Arm Title

Longissimus

Arm Type

Experimental

Arm Description

Gadolinium Magnevist® (gadopentetate dimeglumine) .1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients.

Arm Title

Change from Baseline in Pain Frequency

Arm Type

Experimental

Arm Description

Arm Title

Change from Baseline in Pain Intensity

Arm Type

Experimental

Arm Description

Arm Title

Change from Baseline in CDSS

Arm Type

Experimental

Arm Description

Arm Title

Percent of Patients with Improved PGAS

Arm Type

Experimental

Arm Description

Arm Title

Adverse Reactions with Facial paresis

Arm Type

Experimental

Arm Description

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

Arm Title

Adverse Reactions with Eyelid ptosis

Arm Type

Experimental

Arm Description

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

Arm Title

Adverse Reactions with Bronchitis

Arm Type

Experimental

Arm Description

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

Arm Title

Adverse Reactions with Neck pain

Arm Type

Experimental

Arm Description

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

Arm Title

Adverse Reactions with Muscle stiffness

Arm Type

Experimental

Arm Description

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

Arm Title

Adverse Reactions with Muscular weakness

Arm Type

Experimental

Arm Description

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

Arm Title

Adverse Reactions with Myalgia

Arm Type

Experimental

Arm Description

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

Arm Title

Adverse Reactions with Muscle pain

Arm Type

Experimental

Arm Description

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

Arm Title

Adverse Reactions with Muscle spasms

Arm Type

Experimental

Arm Description

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

Arm Title

Adverse Reactions Injection site pain

Arm Type

Experimental

Arm Description

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

Arm Title

Adverse Reactions with Hypertension

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Gadolinium

Other Intervention Name(s)

Gadolinium Magnevist® (gadopentetate dimeglumine)

Intervention Description

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

Intervention Name(s)

Gadolinium

Other Intervention Name(s)

Gadolinium Magnevist® (gadopentetate dimeglumine)

Intervention Description

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

Intervention Name(s)

Gadolinium

Other Intervention Name(s)

Gadolinium Magnevist® (gadopentetate dimeglumine)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Efficacy of Botox intramuscularly at Week 6

Other Intervention Name(s)

Botox (onabotulinumtoxinA)

Intervention Description

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).

Intervention Type

Drug

Intervention Name(s)

Efficacy of Botox intramuscularly at Week 12

Other Intervention Name(s)

Botox (onabotulinumtoxinA)

Intervention Description

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).

Intervention Type

Drug

Intervention Name(s)

Efficacy of Botox intramuscularly at Week 18

Other Intervention Name(s)

Botox (onabotulinumtoxinA)

Intervention Description

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).

Intervention Type

Drug

Intervention Name(s)

Efficacy of Botox intramuscularly at Week 24

Other Intervention Name(s)

Botox (onabotulinumtoxinA)

Intervention Description

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).

Intervention Type

Drug

Intervention Name(s)

Efficacy of Botox intramuscularly at Week 30

Other Intervention Name(s)

Botox (onabotulinumtoxinA)

Intervention Description

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).

Intervention Type

Drug

Intervention Name(s)

Efficacy of Botox subdermally at Week 6

Other Intervention Name(s)

Botox (onabotulinumtoxinA)

Intervention Description

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).

Intervention Type

Drug

Intervention Name(s)

Efficacy of Botox subdermally at Week 12

Other Intervention Name(s)

Botox (onabotulinumtoxinA)

Intervention Description

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).

Intervention Type

Drug

Intervention Name(s)

Efficacy of Botox subdermally at Week 18

Other Intervention Name(s)

Botox (onabotulinumtoxinA)

Intervention Description

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).

Intervention Type

Drug

Intervention Name(s)

Efficacy of Botox subdermally at Week 24

Other Intervention Name(s)

Botox (onabotulinumtoxinA)

Intervention Description

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).

Intervention Type

Drug

Intervention Name(s)

Efficacy of Botox subdermally at Week 30

Other Intervention Name(s)

Botox (onabotulinumtoxinA)

Intervention Description

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).

Intervention Type

Drug

Intervention Name(s)

Adverse Reactions of Botox intramuscularly

Other Intervention Name(s)

Botox (onabotulinumtoxinA)

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Adverse Reactions of Botox subdermally

Other Intervention Name(s)

Botox (onabotulinumtoxinA)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Relative Prolongation Ability Score for Gadolinium subdermally injected.

Description

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Efficacy of Botox intramuscularly vs. subdermally in Cervical Dystonia.

Description

Time Frame

12 months

Other Pre-specified Outcome Measures:

Title

Adverse Reactions of Botox intramuscularly vs. subdermally in Cervical Dystonia.

Description

Adverse Reactions of Botox intramuscularly vs. subdermally: Headache Migraine, Facial paresis, Eyelid ptosis, Bronchitis, Neck pain Musculoskeletal stiffness, Muscular weakness Myalgia, Musculoskeletal pain, Muscle spasms, Injection site pain, and Hypertension.

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Li Nguyen, MD

Phone

(714)-453-7857

dr.li.nguyen@asis-inc.com

First Name & Middle Initial & Last Name or Official Title & Degree

Thanh Phung, MD

Phone

714-893-1915

thanhphung@idit-inc.com

Facility Information:

Facility Name

Automatic Subdermal Injector System, Inc

City

Westminster

State/Province

California

ZIP/Postal Code

92683

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Li Nguyen, MD

Phone

714-453-7857

dr.li.nguyen@asis-inc.com

First Name & Middle Initial & Last Name & Degree

Thanh Phung, MD

Phone

(714)-893-1915

thanhphung@idit-inc.com

First Name & Middle Initial & Last Name & Degree

Li Nguyen, MD

First Name & Middle Initial & Last Name & Degree

Thanh Phung, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

23515199

Citation

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PubMed Identifier

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Citation

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Citation

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Citation

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23893443

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Albanese A, Sorbo FD, Comella C, Jinnah HA, Mink JW, Post B, Vidailhet M, Volkmann J, Warner TT, Leentjens AF, Martinez-Martin P, Stebbins GT, Goetz CG, Schrag A. Dystonia rating scales: critique and recommendations. Mov Disord. 2013 Jun 15;28(7):874-83. doi: 10.1002/mds.25579.

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23779062

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Evidente VG, Fernandez HH, LeDoux MS, Brashear A, Grafe S, Hanschmann A, Comella CL. A randomized, double-blind study of repeated incobotulinumtoxinA (Xeomin((R))) in cervical dystonia. J Neural Transm (Vienna). 2013 Dec;120(12):1699-707. doi: 10.1007/s00702-013-1048-3. Epub 2013 Jun 19.

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Leplow B, Bottcher M, Schonfeld R. [Botulinum toxin therapy for spasmodic torticollis: medical and non-medical adjunct treatment]. Nervenarzt. 2013 Apr;84(4):493-7. doi: 10.1007/s00115-012-3708-1. German.

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Vivancos-Matellano F, Ybot-Gorrin I, Diez-Tejedor E. A 17-year experience of abobotulinumtoxina in cervical dystonia. Int J Neurosci. 2012 Jul;122(7):354-7. doi: 10.3109/00207454.2012.665971. Epub 2012 Mar 20. Erratum In: Int J Neurosci. 2012 Dec;122(12):767.

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