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ASIS for Botox in Chronic Migraine (ASISinCM)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2015 by ASIS Corporation.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02074163
First Posted: February 28, 2014
Last Update Posted: June 24, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
ASIS Corporation
  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
Chronic Migraine More than15 Days Per Month, and Lasting 4 Hours a Day or Longer. 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
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: ASIS for Botox in Chronic Migraine

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: 12 months ]
    Gadolinium will be injected with ASIS subdermally (30) or conventional intramuscularly (30) in Chronic Migraine adult patients for these 6 muscle groups: Glabella, Frontal, Temporal, Occipital, Paraspinal, and Trapezius. 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 Chronic Migraine, and these particular 6 muscle groups. The Relative Prolongation Ability Score or total Persistent % subdermally over total Persistent % intramuscularly, in Chronic Migraine patients will not be like those of normal patients, or even the same between these 6 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 Chronic Migraine. [ Time Frame: 12 months ]
    Efficacy of Botox intramuscularly vs. subdermally with ASIS Device at Week 6,12,18, 24, and 30; in terms of Change from baseline in frequency of headache days, and Change from baseline in total cumulative hours of headache on headache days.


Other Outcome Measures:
  • Adverse Reactions of Botox intramuscularly vs. subdermally in Chronic Migraine. [ Time Frame: 12 months ]

    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: January 2016
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Glabella

Glabella

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
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: Frontal

Frontal

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
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: Temporal

Temporal

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
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: Occipital

Occipital

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
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: Paraspinal

Paraspinal

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
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

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
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 in frequency of headache days
Change in frequency of headache days 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 Change in frequency of headache days, and Change in hrs of HA on HA days.
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox intramuscularly at Week 12
Efficacy of Botox (onabotulinumtoxinA) intramuscularly at Week 12, in terms of Change in frequency of headache days, and Change in hrs of HA on HA days.
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox intramuscularly at Week 18
Efficacy of Botox (onabotulinumtoxinA) intramuscularly at Week 18, in terms of Change in frequency of headache days, and Change in hrs of HA on HA days.
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox intramuscularly at Week 24,
Efficacy of Botox (onabotulinumtoxinA) intramuscularly at Week 24, in terms of Change in frequency of headache days, and Change in hrs of HA on HA days.
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox intramuscularly at Week 30
Efficacy of Botox (onabotulinumtoxinA) intramuscularly at Week 30, in terms of Change in frequency of headache days, and Change in hrs of HA on HA days.
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox subdermally at Week 6
Efficacy of Botox (onabotulinumtoxinA) subdermally at Week 6, in terms of Change in frequency of headache days, and Change in hrs of HA on HA days.
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox subdermally at Week 12
Efficacy of Botox (onabotulinumtoxinA) subdermally at Week 12, in terms of Change in frequency of headache days, and Change in hrs of HA on HA days.
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox subdermally at Week 18
Efficacy of Botox (onabotulinumtoxinA) subdermally at Week 18, in terms of Change in frequency of headache days, and Change in hrs of HA on HA days.
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox subdermally at Week 24
Efficacy of Botox (onabotulinumtoxinA) subdermally at Week 24, in terms of Change in frequency of headache days, and Change in hrs of HA on HA days.
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox subdermally at Week 30
Efficacy of Botox (onabotulinumtoxinA) subdermally at Week 30, in terms of Change in frequency of headache days, and Change in hrs of HA on HA days.
Other Name: Botox (onabotulinumtoxinA)
Experimental: Change in hrs of HA on HA days
Change in hrs of HA on HA days 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 Change in frequency of headache days, and Change in hrs of HA on HA days.
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox intramuscularly at Week 12
Efficacy of Botox (onabotulinumtoxinA) intramuscularly at Week 12, in terms of Change in frequency of headache days, and Change in hrs of HA on HA days.
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox intramuscularly at Week 18
Efficacy of Botox (onabotulinumtoxinA) intramuscularly at Week 18, in terms of Change in frequency of headache days, and Change in hrs of HA on HA days.
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox intramuscularly at Week 24,
Efficacy of Botox (onabotulinumtoxinA) intramuscularly at Week 24, in terms of Change in frequency of headache days, and Change in hrs of HA on HA days.
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox intramuscularly at Week 30
Efficacy of Botox (onabotulinumtoxinA) intramuscularly at Week 30, in terms of Change in frequency of headache days, and Change in hrs of HA on HA days.
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox subdermally at Week 6
Efficacy of Botox (onabotulinumtoxinA) subdermally at Week 6, in terms of Change in frequency of headache days, and Change in hrs of HA on HA days.
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox subdermally at Week 12
Efficacy of Botox (onabotulinumtoxinA) subdermally at Week 12, in terms of Change in frequency of headache days, and Change in hrs of HA on HA days.
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox subdermally at Week 18
Efficacy of Botox (onabotulinumtoxinA) subdermally at Week 18, in terms of Change in frequency of headache days, and Change in hrs of HA on HA days.
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox subdermally at Week 24
Efficacy of Botox (onabotulinumtoxinA) subdermally at Week 24, in terms of Change in frequency of headache days, and Change in hrs of HA on HA days.
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox subdermally at Week 30
Efficacy of Botox (onabotulinumtoxinA) subdermally at Week 30, in terms of Change in frequency of headache days, and Change in hrs of HA on HA days.
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 Chronic Migraine (≥15 days per month, with headache lasting 4 hours a day or longer). Gadolinium will be injected with ASIS subdermally (30) or conventional intramuscularly (30) for these 6 muscle groups: Glabella, Frontal, Temporal, Occipital, Paraspinal, and Trapezius. 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 Chronic Migraine, and these particular 6 muscle groups. Case in point, patients with Chronic Migraine presumably have hyperactive Glabella, Frontal, Temporal, Occipital, Paraspinal, and Trapezius muscles, so expectantly will have shortened Gadolinium intramuscularly Persistent %, and somewhat Gadolinium subdermally Persistent % as well due to agitation, thus these Persistent % values in Chronic Migraine patients will not be like those of normal patients, or even the same between these 6 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 the Botox dosage and duration to inject into that "unknown" subdermal bloodless space for Aim 2.

Aim 2 over 12 months, using Botox, instead of Gadolinium, to demonstrate the advantages of ASIS device subdermally over intramuscularly, for the particular 6 muscle groups on the same 60 Chronic Migraine adults. Given that there isn't a way to detect Botox in the peripheral blood to document Prolongation of Botox Pharmacokinetically, this Relative Prolongation Ability is our best and only possible way to demonstrate that subdermal bloodless space's ability on Botox. Although valuable, that Relative Prolongation Ability Score from Aim 1 isn't absolutely required to start Aim 2. Hypothetically speaking, if that subdermal bloodless space in patients with e.g., Chronic Migraine 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 reduction in Number of Headache Days from Baseline, and adverse reactions.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must have history of chronic migraine (with or without aura) according to the criteria proposed by the Headache Classification Committee of the International Headache Society for at least 3 months prior to enrollment.
  • Must be able to understand the requirements of the study including maintaining a headache diary, and signing informed consent.
  • If taking migraine preventive, must be on a stable dose of preventive medication for at least 3 months.

Exclusion Criteria:

  • Has headache disorders outside IHS-defined chronic migraine definition.
  • Has evidence of underlying pathology contributing to their headaches.
  • Has any pathology of the salivary glands such as sialadenitis (e.g. Sjogren's syndrome, viral or bacterial sialadenitis) or condition or symptom that would alter the content of saliva.
  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02074163


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         
Sponsors and Collaborators
ASIS Corporation
Investigators
Principal Investigator: Li Nguyen, MD AUTOMATIC SUBDERMAL INJECTOR SYSTEM INC
Principal Investigator: Thanh Phung, MD AUTOMATIC SUBDERMAL INJECTOR SYSTEM, INC
  More Information

Additional Information:
Publications:
Bartleson JD, Cutrer FM. Migraine update. Diagnosis and treatment. Minn Med. 2010 May;93(5):36-41. Review.
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. Review.
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. Erratum in: Invest Radiol. 2006 Sep;41(9):667.
Montagna P. Migraine genetics. Expert Rev Neurother. 2008 Sep;8(9):1321-30. doi: 10.1586/14737175.8.9.1321. Review.
Robbins MS, Lipton RB. The epidemiology of primary headache disorders. Semin Neurol. 2010 Apr;30(2):107-19. doi: 10.1055/s-0030-1249220. Epub 2010 Mar 29. Review.
Levy D, Strassman AM, Burstein R. A critical view on the role of migraine triggers in the genesis of migraine pain. Headache. 2009 Jun;49(6):953-7. doi: 10.1111/j.1526-4610.2009.01444.x. Review.
Cousins G, Hijazze S, Van de Laar FA, Fahey T. Diagnostic accuracy of the ID Migraine: a systematic review and meta-analysis. Headache. 2011 Jul-Aug;51(7):1140-8. doi: 10.1111/j.1526-4610.2011.01916.x. Epub 2011 Jun 7. Review.
Olesen J, Burstein R, Ashina M, Tfelt-Hansen P. Origin of pain in migraine: evidence for peripheral sensitisation. Lancet Neurol. 2009 Jul;8(7):679-90. doi: 10.1016/S1474-4422(09)70090-0. Review.

Responsible Party: ASIS Corporation
ClinicalTrials.gov Identifier: NCT02074163     History of Changes
Other Study ID Numbers: NCTNS088800
R01NS088800 ( Other Grant/Funding Number: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE )
First Submitted: February 26, 2014
First Posted: February 28, 2014
Last Update Posted: June 24, 2015
Last Verified: June 2015

Keywords provided by ASIS Corporation:
Subdermal bloodless space
Subdermal injection
injectable EMG needle
electrical stimulation
MRI with Gadolinium
Chronic Migraine
intramuscular injection

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
onabotulinumtoxinA
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents


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