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Treatment of Chronic Migraine Headaches. (Migraine)

This study is currently recruiting participants.
Verified July 2017 by Corona Doctors Medical Clinics, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03220113
First Posted: July 18, 2017
Last Update Posted: July 21, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Corona Doctors Medical Clinics, Inc.
  Purpose

The purpose of the study is assessment of the safety and efficacy of the De-Novo therapy in the treatment of craniofacial neuralgia and migraine headaches.This is an open-label study of simultaneous administration of combination of dexamethasone, lidocaine, and thiamine into the trigeminal nerve branches as well as greater and lesser occipital nerve bilaterally in one session.

Patients who meet the exclusion and inclusion criteria are eligible for trial if they have experienced chronic migraine and craniofacial pain not responding to other prior therapies.


Condition Intervention Phase
Chronic Migraine Without Aura, Intractable Migraine With Typical Aura Migraine Disorders Combination Product: Dexamethasone, Lidocaine, Thiamine cohort Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Intervention Model Description:
Prospective Open Label Study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of De-Novo Algorithm and Formula in the Treatment of Patients With Intractable Chronic Craniofacial Neuralgia, or Chronic Migraine Headaches.

Resource links provided by NLM:


Further study details as provided by Corona Doctors Medical Clinics, Inc.:

Primary Outcome Measures:
  • Assessment of the safety to the De-Novo treatment formula in study patients [ Time Frame: 5 weeks ]
    Study assesses the safety of the De-Novo algorithm( if patients who receive this treatment will experience any major adverse reactions due to the medication combination )within the next 5 weeks following treatment. Participants will be interviewed after the initial treatment weekly, for 5 weeks to evaluate for any possible adverse events, hospitalization, or treatment. Any significant adverse event in over 45% of participants, may project end of the trial.


Secondary Outcome Measures:
  • Assessment of the clinical response to the De-Novo treatment formula in study patients consisting of a lone composite measure [ Time Frame: 12 months ]

    Assessment of the clinical response to the De-Novo treatment formula in study patients.

    Study assesses the efficacy parameters of the study ( i.e. the change in baseline frequency of migraine attack in patients post initial treatment ), and functionality status based on continuation of work performance and return to work or school.

    Therefore, the Outcome of study consisting of multiple measures and present lone composite measure.



Estimated Enrollment: 100
Actual Study Start Date: July 1, 2017
Estimated Study Completion Date: July 1, 2019
Estimated Primary Completion Date: July 1, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dexamethasone,Lidocaine,Thiamine cohort

Simultaneous administration of a combination of sterile dexamethasone phosphate total dose (bilaterally) of 20 mg, 4 mg/ml, Lidocaine Hydrochloride 1% 40 mg, 10 mg/ml, and Thiamine, 100 mg, 100 mg/ml in a single session into the accessible branches of the trigeminal nerve of the first, second, and third divisions, as well as into the greater and lesser occipital nerve. In first,patient placed in supine position then in prone position for comfortable access to injection site.

De-Novo Treatment medication 'Dexamethasone, Lidocaine, Thiamine Cohort' prepared in single 1 milliliter volume sterile syringes, using 27 Gauge-30 Gauge needles.

Combination Product: Dexamethasone, Lidocaine, Thiamine cohort
Bilateral and simultaneous administration of composition of De-Novo Treatment Cohort medication (Dexamethasone, Lidocaine, Thiamine) into the trigeminal and greater/lesser occipital nerves in one session.In children and hypersensitive individuals with needle phobia pre-treatment of skin with Lidocaine 2.5% Prilocaine 2.5% cream, and oral Alprazolam 0.25 mg (an Anxiolytic) 2 hours prior to initiation of procedure will be used.
Other Name: De-Novo Treatment Cohort medication

Detailed Description:

A combination of dexamethasone, lidocaine and thiamine may bring changes in the pattern of sympathetic and parasympathetic nerve signaling at the level vasa nervorum. These changes may down-regulate the hyperexcitable sympathetic signals at the level of adventitia and consequently the medial layer of vasa nervorum and providing long term relief from migraine headaches. However, a bilateral and simultaneous treatment of trigeminal and occipital nerves in migraine and craniofacial neuralgia using a combination of dexamethasone, thiamine and lidocaine has been rarely studied.

The objective of this study is to assess the safety and efficacy of concomitant administration of dexamethasone, lidocaine, and thiamine compounds into the trigeminal nerve branches, the greater and lesser occipital nerve for the treatment of chronic migraine, and craniofacial neuralgia.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   10 Years to 90 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • • Age: 10-90 years

    • Ability to describe headache and its symptoms
    • Ability to read, comprehend, and legibly and reliably record information
    • Ability to provide written, informed consent, and respond to pre and post treatment questionnaires, children's guardian accepts responsibility. Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures
    • Already diagnosed with chronic craniofacial neuralgia and chronic migraine headache
    • Exhausted all or most of available abortive and preventive treatment modalities.

Exclusion Criteria:

  • • Uncontrollable hypertension, acute Myocardial Infarct within last 6 months

    • History of cerebral vascular aneurysm/known atherosclerosis of cerebral system, brain tumor
    • Implanted of neuro-stimulator, trigeminal tractotomy, neurectomy partial or complete, history of gamma knife treatment, microsurgical decompression procedure.
    • Hypersensitivity or allergy to any components of De-Novo formula
    • Presence or known anatomic craniofacial deformities or severe spondylosis/spondylolisthesis of cervical spine, profound dental caries, Maxillofacial deformities
    • Pregnancy and current breast feeding status
    • Headaches attribute to acute head and neck injuries, chronicity of cervicogenic headaches
    • Skin infection or micro abscesses dermatogen or dental, ongoing treatment for Methicillin Resistant Streptococcus Aureus ( MRSA) unless treatment completed.
  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): NCT03220113


Contacts
Contact: Faro T. Owiesy, M.D. 9513719500 owiesymd@gmail.com
Contact: Jovana Martin Murillo 9513719500 coronadoctors@aol.com

Locations
United States, California
Corona Doctors Medical Clinics Inc Recruiting
Corona, California, United States, 92879
Contact: Faro T Owiesy    951-371-9500    owiesymd@gmail.com   
Contact: Jovana Martin Murillo    9513719500    coronadoctors@aol.com   
Principal Investigator: Faro T Owiesy, MD         
Sponsors and Collaborators
Corona Doctors Medical Clinics, Inc.
Investigators
Principal Investigator: Faro T. Owiesy, M.D. Corona Doctors Medical Clinics, Inc.
  More Information

Publications:
Sechi G, Serra A. Wernicke's encephalopathy: new clinical settings and recent advances in diagnosis and management. Lancet Neurol. 2007 May;6(5):442-55. Review.
Negovskiĭ VA. [History of resuscitation in the USSR]. Vestn Akad Med Nauk SSSR. 1975;(12):26-9. Russian.
Johri S, Shetty S, Soni A, Kumar S. Anaphylaxis from intravenous thiamine--long forgotten? Am J Emerg Med. 2000 Sep;18(5):642-3.
Morinville V, Jeannet-Peter N, Hauser C. Anaphylaxis to parenteral thiamine (vitamin B1). Schweiz Med Wochenschr. 1998 Oct 31;128(44):1743-4.
Van Haecke P, Ramaekers D, Vanderwegen L, Boonen S. Thiamine-induced anaphylactic shock. Am J Emerg Med. 1995 May;13(3):371-2. Review.
Wrenn KD, Murphy F, Slovis CM. A toxicity study of parenteral thiamine hydrochloride. Ann Emerg Med. 1989 Aug;18(8):867-70.
De Bold JF, Ruppert PH, Clemens LG. Inhibition of estrogen-induced sexual receptivity of female hamsters: comparative effects of progesterone, dihydrotestosterone and an estrogen antagonist. Pharmacol Biochem Behav. 1978 Jul;9(1):81-6.
Hayashi Y. Effects of intra-amygdaloid injections of alpha-difluoromethylornithine and putrescine on the development of electrical kindling in rats. Brain Res. 1991 Sep 27;560(1-2):181-5.
Shoeb M, Ramana KV. Anti-inflammatory effects of benfotiamine are mediated through the regulation of the arachidonic acid pathway in macrophages. Free Radic Biol Med. 2012 Jan 1;52(1):182-90. doi: 10.1016/j.freeradbiomed.2011.10.444. Epub 2011 Oct 24.
Newman SP. Aerosol deposition considerations in inhalation therapy. Chest. 1985 Aug;88(2 Suppl):152S-160S. Review.
Yadav UC, Kalariya NM, Srivastava SK, Ramana KV. Protective role of benfotiamine, a fat-soluble vitamin B1 analogue, in lipopolysaccharide-induced cytotoxic signals in murine macrophages. Free Radic Biol Med. 2010 May 15;48(10):1423-34. doi: 10.1016/j.freeradbiomed.2010.02.031. Epub 2010 Feb 26.
Yadav UC, Subramanyam S, Ramana KV. Prevention of endotoxin-induced uveitis in rats by benfotiamine, a lipophilic analogue of vitamin B1. Invest Ophthalmol Vis Sci. 2009 May;50(5):2276-82. doi: 10.1167/iovs.08-2816. Epub 2009 Jan 10.
Tai HH, Tong M, Ding Y. 15-hydroxyprostaglandin dehydrogenase (15-PGDH) and lung cancer. Prostaglandins Other Lipid Mediat. 2007 May;83(3):203-8. Epub 2007 Jan 17. Review.
Liu S, Stromberg A, Tai HH, Moscow JA. Thiamine transporter gene expression and exogenous thiamine modulate the expression of genes involved in drug and prostaglandin metabolism in breast cancer cells. Mol Cancer Res. 2004 Aug;2(8):477-87.
Rodríguez Meléndez R. [Importance of water-soluble vitamins as regulatory factors of genetic expression]. Rev Invest Clin. 2002 Jan-Feb;54(1):77-83. Review. Spanish.
Bettendorff L, Wins P. Thiamin diphosphate in biological chemistry: new aspects of thiamin metabolism, especially triphosphate derivatives acting other than as cofactors. FEBS J. 2009 Jun;276(11):2917-25. doi: 10.1111/j.1742-4658.2009.07019.x. Epub 2009 Apr 23. Review.
Hazell AS, Butterworth RF. Update of cell damage mechanisms in thiamine deficiency: focus on oxidative stress, excitotoxicity and inflammation. Alcohol Alcohol. 2009 Mar-Apr;44(2):141-7. doi: 10.1093/alcalc/agn120. Epub 2009 Jan 16. Review.
Desjardins P, Butterworth RF. Role of mitochondrial dysfunction and oxidative stress in the pathogenesis of selective neuronal loss in Wernicke's encephalopathy. Mol Neurobiol. 2005;31(1-3):17-25. Review.

Responsible Party: Corona Doctors Medical Clinics, Inc.
ClinicalTrials.gov Identifier: NCT03220113     History of Changes
Other Study ID Numbers: 2017/05/1
First Submitted: July 11, 2017
First Posted: July 18, 2017
Last Update Posted: July 21, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No sharing suggested at this time

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Corona Doctors Medical Clinics, Inc.:
Migraine
Craniofacial Neuralgia

Additional relevant MeSH terms:
Migraine Disorders
Migraine without Aura
Migraine with Aura
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Dexamethasone acetate
Dexamethasone
BB 1101
Lidocaine
Thiamine
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors


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