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Neurotoxin

Temporal for Migraine (ASISinCM Trial)

Phase 1 & 2
Waitlist Available
Led By Li Nguyen, MD
Research Sponsored by ASIS Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

ASISinCM Trial 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.

Eligible Conditions
  • Migraine

ASISinCM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Relative Prolongation Ability Score for Gadolinium subdermally injected.
Secondary outcome measures
Efficacy of Botox intramuscularly vs. subdermally in Chronic Migraine.
Other outcome measures
Adverse Reactions of Botox intramuscularly vs. subdermally in Chronic Migraine.

ASISinCM Trial Design

19Treatment groups
Experimental Treatment
Group I: TrapeziusExperimental Treatment1 Intervention
Trapezius Gadolinium Magnevist® (gadopentetate dimeglumine) .1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients.
Group II: TemporalExperimental Treatment1 Intervention
Temporal Gadolinium Magnevist® (gadopentetate dimeglumine) .1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients.
Group III: ParaspinalExperimental Treatment1 Intervention
Paraspinal Gadolinium Magnevist® (gadopentetate dimeglumine) .1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients.
Group IV: OccipitalExperimental Treatment1 Intervention
Occipital Gadolinium Magnevist® (gadopentetate dimeglumine) .1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients.
Group V: GlabellaExperimental Treatment1 Intervention
Glabella Gadolinium Magnevist® (gadopentetate dimeglumine) .1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients.
Group VI: FrontalExperimental Treatment1 Intervention
Frontal Gadolinium Magnevist® (gadopentetate dimeglumine) .1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients.
Group VII: Change in hrs of HA on HA daysExperimental Treatment10 Interventions
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.
Group VIII: Change in frequency of headache daysExperimental Treatment10 Interventions
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.
Group IX: Adverse Reactions with Neck painExperimental Treatment2 Interventions
Neck pain as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Group X: Adverse Reactions with MyalgiaExperimental Treatment2 Interventions
Myalgia as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Group XI: Adverse Reactions with Muscular weaknessExperimental Treatment2 Interventions
Muscular weakness as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Group XII: Adverse Reactions with Muscle stiffnessExperimental Treatment2 Interventions
Musculoskeletal stiffness as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Group XIII: Adverse Reactions with Muscle spasmsExperimental Treatment2 Interventions
Muscle spasms as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Group XIV: Adverse Reactions with Muscle painExperimental Treatment2 Interventions
Musculoskeletal pain as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Group XV: Adverse Reactions with HypertensionExperimental Treatment2 Interventions
Hypertension as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Group XVI: Adverse Reactions with Facial paresisExperimental Treatment2 Interventions
Facial paresis as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Group XVII: Adverse Reactions with Eyelid ptosisExperimental Treatment2 Interventions
Eyelid ptosis as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Group XVIII: Adverse Reactions with BronchitisExperimental Treatment2 Interventions
Bronchitis as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Group XIX: Adverse Reactions Injection site painExperimental Treatment2 Interventions
Injection site pain as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gadolinium
FDA approved

Find a Location

Who is running the clinical trial?

ASIS CorporationLead Sponsor
2 Previous Clinical Trials
120 Total Patients Enrolled
Li Nguyen, MDPrincipal InvestigatorAUTOMATIC SUBDERMAL INJECTOR SYSTEM INC
3 Previous Clinical Trials
180 Total Patients Enrolled
Thanh Phung, MDPrincipal InvestigatorAUTOMATIC SUBDERMAL INJECTOR SYSTEM, INC
1 Previous Clinical Trials
60 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
ASIS for Botox in Chronic Migraine
2016. "ASIS for Botox in Chronic Migraine". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02074163.
All > Migraine
~6 spots leftby Apr 2025
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