ASIS for Botox in Cervical Dystonia (ASISinCD)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by ASIS Corporation
Sponsor:
Information provided by (Responsible Party):
li nguyen, ASIS Corporation
ClinicalTrials.gov Identifier:
NCT02074293
First received: February 26, 2014
Last updated: NA
Last verified: February 2014
History: No changes posted
  Purpose

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.


Condition Intervention Phase
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.
Drug: Gadolinium
Drug: Efficacy of Botox intramuscularly at Week 6
Drug: Efficacy of Botox intramuscularly at Week 12
Drug: Efficacy of Botox intramuscularly at Week 18
Drug: Efficacy of Botox intramuscularly at Week 24
Drug: Efficacy of Botox intramuscularly at Week 30
Drug: Efficacy of Botox subdermally at Week 6
Drug: Efficacy of Botox subdermally at Week 12
Drug: Efficacy of Botox subdermally at Week 18
Drug: Efficacy of Botox subdermally at Week 24
Drug: Efficacy of Botox subdermally at Week 30
Drug: Adverse Reactions of Botox intramuscularly
Drug: Adverse Reactions of Botox subdermally
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: ASIS for Botox in Cervical Dystonia

Resource links provided by NLM:


Further study details as provided by ASIS Corporation:

Primary Outcome Measures:
  • Relative Prolongation Ability Score for Gadolinium subdermally injected. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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).


Other Outcome Measures:
  • Adverse Reactions of Botox intramuscularly vs. subdermally in Cervical Dystonia. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

    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.



Estimated Enrollment: 60
Study Start Date: June 2014
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Splenius

Gadolinium Magnevist® (gadopentetate dimeglumine)

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

Drug: 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.
Other Name: Gadolinium Magnevist® (gadopentetate dimeglumine)
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.
Other Name: Gadolinium Magnevist® (gadopentetate dimeglumine)
Drug: Gadolinium
Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium intramuscularly on MRI.
Other Name: Gadolinium Magnevist® (gadopentetate dimeglumine)
Experimental: Scalene

Gadolinium Magnevist® (gadopentetate dimeglumine)

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

Drug: 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.
Other Name: Gadolinium Magnevist® (gadopentetate dimeglumine)
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.
Other Name: Gadolinium Magnevist® (gadopentetate dimeglumine)
Drug: Gadolinium
Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium intramuscularly on MRI.
Other Name: Gadolinium Magnevist® (gadopentetate dimeglumine)
Experimental: Sterno-cleido-mastoid

Gadolinium Magnevist® (gadopentetate dimeglumine)

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

Drug: 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.
Other Name: Gadolinium Magnevist® (gadopentetate dimeglumine)
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.
Other Name: Gadolinium Magnevist® (gadopentetate dimeglumine)
Drug: Gadolinium
Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium intramuscularly on MRI.
Other Name: Gadolinium Magnevist® (gadopentetate dimeglumine)
Experimental: Levator Scapulae

Gadolinium Magnevist® (gadopentetate dimeglumine)

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

Drug: 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.
Other Name: Gadolinium Magnevist® (gadopentetate dimeglumine)
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.
Other Name: Gadolinium Magnevist® (gadopentetate dimeglumine)
Drug: Gadolinium
Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium intramuscularly on MRI.
Other Name: Gadolinium Magnevist® (gadopentetate dimeglumine)
Experimental: Semispinalis

Gadolinium Magnevist® (gadopentetate dimeglumine)

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

Drug: 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.
Other Name: Gadolinium Magnevist® (gadopentetate dimeglumine)
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.
Other Name: Gadolinium Magnevist® (gadopentetate dimeglumine)
Drug: Gadolinium
Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium intramuscularly on MRI.
Other Name: Gadolinium Magnevist® (gadopentetate dimeglumine)
Experimental: Trapezius

Gadolinium Magnevist® (gadopentetate dimeglumine)

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

Drug: 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.
Other Name: Gadolinium Magnevist® (gadopentetate dimeglumine)
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.
Other Name: Gadolinium Magnevist® (gadopentetate dimeglumine)
Drug: Gadolinium
Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium intramuscularly on MRI.
Other Name: Gadolinium Magnevist® (gadopentetate dimeglumine)
Experimental: Longissimus

Gadolinium Magnevist® (gadopentetate dimeglumine)

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

Drug: 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.
Other Name: Gadolinium Magnevist® (gadopentetate dimeglumine)
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.
Other Name: Gadolinium Magnevist® (gadopentetate dimeglumine)
Drug: Gadolinium
Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium intramuscularly on MRI.
Other Name: Gadolinium Magnevist® (gadopentetate dimeglumine)
Experimental: 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.
Drug: Efficacy of Botox intramuscularly at Week 6
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).
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox intramuscularly at Week 12
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).
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox intramuscularly at Week 18
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).
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox intramuscularly at Week 24
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).
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox intramuscularly at Week 30
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).
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox subdermally at Week 6
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).
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox subdermally at Week 12
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).
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox subdermally at Week 18
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).
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox subdermally at Week 24
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).
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox subdermally at Week 30
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).
Other Name: Botox (onabotulinumtoxinA)
Experimental: 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).
Drug: Efficacy of Botox intramuscularly at Week 6
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).
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox intramuscularly at Week 12
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).
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox intramuscularly at Week 18
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).
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox intramuscularly at Week 24
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).
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox intramuscularly at Week 30
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).
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox subdermally at Week 6
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).
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox subdermally at Week 12
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).
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox subdermally at Week 18
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).
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox subdermally at Week 24
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).
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox subdermally at Week 30
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).
Other Name: Botox (onabotulinumtoxinA)
Experimental: 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).
Drug: Efficacy of Botox intramuscularly at Week 6
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).
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox intramuscularly at Week 12
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).
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox intramuscularly at Week 18
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).
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox intramuscularly at Week 24
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).
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox intramuscularly at Week 30
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).
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox subdermally at Week 6
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).
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox subdermally at Week 12
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).
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox subdermally at Week 18
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).
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox subdermally at Week 24
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).
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox subdermally at Week 30
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).
Other Name: Botox (onabotulinumtoxinA)
Experimental: 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.
Drug: Efficacy of Botox intramuscularly at Week 6
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).
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox intramuscularly at Week 12
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).
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox intramuscularly at Week 18
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).
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox intramuscularly at Week 24
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).
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox intramuscularly at Week 30
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).
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox subdermally at Week 6
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).
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox subdermally at Week 12
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).
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox subdermally at Week 18
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).
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox subdermally at Week 24
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).
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox subdermally at Week 30
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).
Other Name: Botox (onabotulinumtoxinA)
Experimental: Adverse Reactions with Facial paresis
Facial paresis as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Drug: Adverse Reactions of Botox intramuscularly
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.
Other Name: Botox (onabotulinumtoxinA)
Drug: Adverse Reactions of Botox subdermally
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.
Other Name: Botox (onabotulinumtoxinA)
Experimental: Adverse Reactions with Eyelid ptosis
Eyelid ptosis as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Drug: Adverse Reactions of Botox intramuscularly
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.
Other Name: Botox (onabotulinumtoxinA)
Drug: Adverse Reactions of Botox subdermally
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.
Other Name: Botox (onabotulinumtoxinA)
Experimental: Adverse Reactions with Bronchitis
Bronchitis as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Drug: Adverse Reactions of Botox intramuscularly
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.
Other Name: Botox (onabotulinumtoxinA)
Drug: Adverse Reactions of Botox subdermally
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.
Other Name: Botox (onabotulinumtoxinA)
Experimental: Adverse Reactions with Neck pain
Neck pain as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Drug: Adverse Reactions of Botox intramuscularly
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.
Other Name: Botox (onabotulinumtoxinA)
Drug: Adverse Reactions of Botox subdermally
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.
Other Name: Botox (onabotulinumtoxinA)
Experimental: Adverse Reactions with Muscle stiffness
Musculoskeletal stiffness as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Drug: Adverse Reactions of Botox intramuscularly
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.
Other Name: Botox (onabotulinumtoxinA)
Drug: Adverse Reactions of Botox subdermally
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.
Other Name: Botox (onabotulinumtoxinA)
Experimental: Adverse Reactions with Muscular weakness
Muscular weakness as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Drug: Adverse Reactions of Botox intramuscularly
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.
Other Name: Botox (onabotulinumtoxinA)
Drug: Adverse Reactions of Botox subdermally
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.
Other Name: Botox (onabotulinumtoxinA)
Experimental: Adverse Reactions with Myalgia
Myalgia as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Drug: Adverse Reactions of Botox intramuscularly
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.
Other Name: Botox (onabotulinumtoxinA)
Drug: Adverse Reactions of Botox subdermally
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.
Other Name: Botox (onabotulinumtoxinA)
Experimental: Adverse Reactions with Muscle pain
Musculoskeletal pain as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Drug: Adverse Reactions of Botox intramuscularly
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.
Other Name: Botox (onabotulinumtoxinA)
Drug: Adverse Reactions of Botox subdermally
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.
Other Name: Botox (onabotulinumtoxinA)
Experimental: Adverse Reactions with Muscle spasms
Muscle spasms as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Drug: Adverse Reactions of Botox intramuscularly
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.
Other Name: Botox (onabotulinumtoxinA)
Drug: Adverse Reactions of Botox subdermally
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.
Other Name: Botox (onabotulinumtoxinA)
Experimental: Adverse Reactions Injection site pain
Injection site pain as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Drug: Adverse Reactions of Botox intramuscularly
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.
Other Name: Botox (onabotulinumtoxinA)
Drug: Adverse Reactions of Botox subdermally
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.
Other Name: Botox (onabotulinumtoxinA)
Experimental: Adverse Reactions with Hypertension
Hypertension as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Drug: Adverse Reactions of Botox intramuscularly
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.
Other Name: Botox (onabotulinumtoxinA)
Drug: Adverse Reactions of Botox subdermally
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.
Other Name: Botox (onabotulinumtoxinA)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02074293

Contacts
Contact: Li Nguyen, MD (714)-453-7857 dr.li.nguyen@asis-inc.com
Contact: Thanh Phung, MD 714-893-1915 thanhphung@idit-inc.com

Locations
United States, California
Automatic Subdermal Injector System, Inc Not yet recruiting
Westminster, California, United States, 92683
Contact: Li Nguyen, MD    714-453-7857    dr.li.nguyen@asis-inc.com   
Contact: Thanh Phung, MD    (714)-893-1915    thanhphung@idit-inc.com   
Principal Investigator: Li Nguyen, MD         
Principal Investigator: Thanh Phung, MD         
Sponsors and Collaborators
li nguyen
  More Information

Additional Information:
Publications:

Responsible Party: li nguyen, MD/CEO/PI, ASIS Corporation
ClinicalTrials.gov Identifier: NCT02074293     History of Changes
Other Study ID Numbers: NCTNS089268, R44NS089268
Study First Received: February 26, 2014
Last Updated: February 26, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by ASIS Corporation:
Subdermal bloodless space
Subdermal injection
injectable EMG needle
electrical stimulation
MRI with Gadolinium
Cervical Dystonia
intramuscular injection
cervical dystonia,

Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Neck Pain
Torticollis
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Dyskinesias
Movement Disorders
Central Nervous System Diseases
Botulinum Toxins, Type A
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014