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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.
A combination of dexamethasone, lidocaine and thiamine (pat.), 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexamethasone,Lidocaine,Thiamine cohort | Experimental | 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 Hydrochloride 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone, Lidocaine, Thiamine cohort | Combination Product | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the safety to the De-Novo treatment formula in study patients | 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. | 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the clinical response to the De-Novo treatment formula in study patients consisting of a lone composite measure | 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. |
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Inclusion Criteria:
• Age: 10-90 years
Exclusion Criteria:
• Uncontrollable hypertension, acute Myocardial Infarct within last 6 months
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Faro T. Owiesy, M.D. | Contact | 9513719500 | owiesymd@gmail.com | |
| Jovana Martin Murillo | Contact | 9513719500 | coronadoctors@aol.com |
| Name | Affiliation | Role |
|---|---|---|
| Faro T. Owiesy, M.D. | Corona Doctors Medical Clinics, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Corona Doctors Medical Clinics Inc | Recruiting | Corona | California | 92879 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17434099 | Background | 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. doi: 10.1016/S1474-4422(07)70104-7. | |
| 775837 | Background | Negovskii VA. [History of resuscitation in the USSR]. Vestn Akad Med Nauk SSSR. 1975;(12):26-9. No abstract available. Russian. |
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No sharing suggested at this time
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| ID | Term |
|---|---|
| D020325 | Migraine with Aura |
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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Prospective Open Label Study
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| 12 months |
| 10999594 | Background | Johri S, Shetty S, Soni A, Kumar S. Anaphylaxis from intravenous thiamine--long forgotten? Am J Emerg Med. 2000 Sep;18(5):642-3. doi: 10.1016/s0735-6757(00)90303-6. No abstract available. |
| 9846348 | Background | Morinville V, Jeannet-Peter N, Hauser C. Anaphylaxis to parenteral thiamine (vitamin B1). Schweiz Med Wochenschr. 1998 Oct 31;128(44):1743-4. |
| 7755837 | Background | Van Haecke P, Ramaekers D, Vanderwegen L, Boonen S. Thiamine-induced anaphylactic shock. Am J Emerg Med. 1995 May;13(3):371-2. doi: 10.1016/0735-6757(95)90221-X. No abstract available. |
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| 704656 | Background | 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. doi: 10.1016/0091-3057(78)90015-1. |
| 1760726 | Background | 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. doi: 10.1016/0006-8993(91)91230-x. |
| 22067901 | Background | 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. |
| 3893925 | Background | Newman SP. Aerosol deposition considerations in inhalation therapy. Chest. 1985 Aug;88(2 Suppl):152S-160S. doi: 10.1378/chest.88.2_supplement.152s. |
| 20219672 | Background | 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. |
| 19136698 | Background | 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. |
| 17481556 | Background | Tai HH, Tong M, Ding Y. 15-hydroxyprostaglandin dehydrogenase (15-PGDH) and lung cancer. Prostaglandins Other Lipid Mediat. 2007 May;83(3):203-8. doi: 10.1016/j.prostaglandins.2007.01.007. Epub 2007 Jan 17. |
| 15328374 | Background | 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. |
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| 19490098 | Background | 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. |
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| 15953809 | Background | 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. doi: 10.1385/MN:31:1-3:017. |
| D009422 | Nervous System Diseases |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |