ASIS for Botox in Chronic Migraine
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Migraine Headaches |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/2/2016 |
| Start Date: | January 2016 |
| End Date: | June 2017 |
| Contact: | Li Nguyen, MD |
| Email: | dr.li.nguyen@asis-inc.com |
| Phone: | (714)-453-7857 |
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.
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.
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.
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.
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.
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