ASIS for Botox in Chronic Migraine

NCT02074163 | Unknown Phase 1 DMC

• 2 other identifiers: NCTNS088800R01NS088800
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Migraine More than15 Days Per Month, and Lasting 4 Hours a Day or Longer.

Keywords

Subdermal bloodless space; Subdermal injection; injectable EMG needle; electrical stimulation; MRI with Gadolinium; Chronic Migraine; intramuscular injection

Outcome Measures

Primary Outcomes (1)

• Relative Prolongation Ability Score for Gadolinium subdermally injected.

  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.

  12 months

Secondary Outcomes (1)

• Efficacy of Botox intramuscularly vs. subdermally in Chronic Migraine.

  12 months

Other Outcomes (1)

• Adverse Reactions of Botox intramuscularly vs. subdermally in Chronic Migraine.

  12 months

Study Arms (19)

Glabella

EXPERIMENTAL

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

Drug: Gadolinium

Frontal

EXPERIMENTAL

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

Drug: Gadolinium

Temporal

EXPERIMENTAL

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

Drug: Gadolinium

Occipital

EXPERIMENTAL

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

Drug: Gadolinium

Paraspinal

EXPERIMENTAL

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

Drug: Gadolinium

Trapezius

EXPERIMENTAL

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

Drug: Gadolinium

Change in frequency of headache days

EXPERIMENTAL

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; 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

Change in hrs of HA on HA days

EXPERIMENTAL

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; 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

Adverse Reactions with Facial paresis

EXPERIMENTAL

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

Drug: Adverse Reactions of Botox intramuscularly; Drug: Adverse Reactions of Botox subdermally

Adverse Reactions with Eyelid ptosis

EXPERIMENTAL

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

Drug: Adverse Reactions of Botox intramuscularly; Drug: Adverse Reactions of Botox subdermally

Adverse Reactions with Bronchitis

EXPERIMENTAL

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

Drug: Adverse Reactions of Botox intramuscularly; Drug: Adverse Reactions of Botox subdermally

Adverse Reactions with Neck pain

EXPERIMENTAL

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

Drug: Adverse Reactions of Botox intramuscularly; Drug: Adverse Reactions of Botox subdermally

Adverse Reactions with Muscle stiffness

EXPERIMENTAL

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

Drug: Adverse Reactions of Botox intramuscularly; Drug: Adverse Reactions of Botox subdermally

Adverse Reactions with Muscular weakness

EXPERIMENTAL

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

Drug: Adverse Reactions of Botox intramuscularly; Drug: Adverse Reactions of Botox subdermally

Adverse Reactions with Myalgia

EXPERIMENTAL

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

Drug: Adverse Reactions of Botox intramuscularly; Drug: Adverse Reactions of Botox subdermally

Adverse Reactions with Muscle pain

EXPERIMENTAL

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

Drug: Adverse Reactions of Botox intramuscularly; Drug: Adverse Reactions of Botox subdermally

Adverse Reactions with Muscle spasms

EXPERIMENTAL

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

Drug: Adverse Reactions of Botox intramuscularly; Drug: Adverse Reactions of Botox subdermally

Adverse Reactions Injection site pain

EXPERIMENTAL

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

Drug: Adverse Reactions of Botox intramuscularly; Drug: Adverse Reactions of Botox subdermally

Adverse Reactions with Hypertension

EXPERIMENTAL

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

Drug: Adverse Reactions of Botox intramuscularly; Drug: Adverse Reactions of Botox subdermally

Interventions

Gadolinium DRUG

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.

Also known as: Gadolinium Magnevist® (gadopentetate dimeglumine)

Frontal; Glabella; Occipital; Paraspinal; Temporal; Trapezius

Efficacy of Botox intramuscularly at Week 6 DRUG

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.

Also known as: Botox (onabotulinumtoxinA)

Change in frequency of headache days; Change in hrs of HA on HA days

Efficacy of Botox intramuscularly at Week 12 DRUG

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.

Also known as: Botox (onabotulinumtoxinA)

Change in frequency of headache days; Change in hrs of HA on HA days

Efficacy of Botox intramuscularly at Week 18 DRUG

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.

Also known as: Botox (onabotulinumtoxinA)

Change in frequency of headache days; Change in hrs of HA on HA days

Efficacy of Botox intramuscularly at Week 24, DRUG

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.

Also known as: Botox (onabotulinumtoxinA)

Change in frequency of headache days; Change in hrs of HA on HA days

Efficacy of Botox intramuscularly at Week 30 DRUG

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.

Also known as: Botox (onabotulinumtoxinA)

Change in frequency of headache days; Change in hrs of HA on HA days

Efficacy of Botox subdermally at Week 6 DRUG

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.

Also known as: Botox (onabotulinumtoxinA)

Change in frequency of headache days; Change in hrs of HA on HA days

Efficacy of Botox subdermally at Week 12 DRUG

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.

Also known as: Botox (onabotulinumtoxinA)

Change in frequency of headache days; Change in hrs of HA on HA days

Efficacy of Botox subdermally at Week 18 DRUG

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.

Also known as: Botox (onabotulinumtoxinA)

Change in frequency of headache days; Change in hrs of HA on HA days

Efficacy of Botox subdermally at Week 24 DRUG

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.

Also known as: Botox (onabotulinumtoxinA)

Change in frequency of headache days; Change in hrs of HA on HA days

Efficacy of Botox subdermally at Week 30 DRUG

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.

Also known as: Botox (onabotulinumtoxinA)

Change in frequency of headache days; Change in hrs of HA on HA days

Adverse Reactions of Botox intramuscularly DRUG

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.

Also known as: Botox (onabotulinumtoxinA)

Adverse Reactions Injection site pain; Adverse Reactions with Bronchitis; Adverse Reactions with Eyelid ptosis; Adverse Reactions with Facial paresis; Adverse Reactions with Hypertension; Adverse Reactions with Muscle pain; Adverse Reactions with Muscle spasms; Adverse Reactions with Muscle stiffness; Adverse Reactions with Muscular weakness; Adverse Reactions with Myalgia; Adverse Reactions with Neck pain

Adverse Reactions of Botox subdermally DRUG

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.

Also known as: Botox (onabotulinumtoxinA)

Adverse Reactions Injection site pain; Adverse Reactions with Bronchitis; Adverse Reactions with Eyelid ptosis; Adverse Reactions with Facial paresis; Adverse Reactions with Hypertension; Adverse Reactions with Muscle pain; Adverse Reactions with Muscle spasms; Adverse Reactions with Muscle stiffness; Adverse Reactions with Muscular weakness; Adverse Reactions with Myalgia; Adverse Reactions with Neck pain

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ASIS Corporation: lead

Study Sites (1)

Automatic Subdermal Injector System, Inc

Westminster, California, 92683, United States

Location

Related Publications (8)

• Bartleson JD, Cutrer FM. Migraine update. Diagnosis and treatment. Minn Med. 2010 May;93(5):36-41.

  PMID: 20572569 BACKGROUND

• 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.

  PMID: 23515199 BACKGROUND

• 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. doi: 10.1097/01.rli.0000209657.16115.42.

  PMID: 16763467 BACKGROUND

• Montagna P. Migraine genetics. Expert Rev Neurother. 2008 Sep;8(9):1321-30. doi: 10.1586/14737175.8.9.1321.

  PMID: 18759544 BACKGROUND

• 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.

  PMID: 20352581 BACKGROUND

• 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.

  PMID: 19545256 BACKGROUND

• 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.

  PMID: 21649653 BACKGROUND

• 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.

  PMID: 19539239 BACKGROUND

Related Links

• Click here for more information about this study ASIS for Botox in Chronic Migraine

MeSH Terms

Interventions

Gadolinium; Gadolinium DTPA; Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Lanthanoid Series Elements; Metals, Rare Earth; Elements; Inorganic Chemicals; Metals; Pentetic Acid; Polyamines; Amines; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Coordination Complexes; Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Li Nguyen, MD

  AUTOMATIC SUBDERMAL INJECTOR SYSTEM INC

  PRINCIPAL INVESTIGATOR

• Thanh Phung, MD

  AUTOMATIC SUBDERMAL INJECTOR SYSTEM, INC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Nguyen, MD

CONTACT

(714)-453-7857; dr.li.nguyen@asis-inc.com

Thanh Phung, MD

CONTACT

714-893-1915; thanhphung@idit-inc.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2014
• First Posted: February 28, 2014
• Study Start: January 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2017
• Last Updated: June 24, 2015

Record last verified: 2015-06

Locations

US (1)