Chronic Migraine Without Aura, IntractablePhase 1/2MigraineNCT03220113
Treatment of Chronic Migraine Headaches.
A Phase 1/2 study testing Dexamethasone, Lidocaine, Thiamine cohort in people with Chronic Migraine Without Aura, Intractable and Migraine With Typical Aura, run by Corona Doctors Medical Clinics, Inc. at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 10 to 90 years
- Conditions the study is for
- Chronic Migraine Without Aura, Intractable, Migraine With Typical Aura, Migraine Disorders
- What is being tested?
- Dexamethasone, Lidocaine, Thiamine cohort
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2017to 1 Jul 2019
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- • 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.
Who cannot join
- • 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Corona Doctors Medical Clinics Inc
Corona, California, 92879
Faro T Owiesy, 951-371-9500, owiesymd@gmail.com
Jovana Martin Murillo, 9513719500, coronadoctors@aol.com
About this study
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.
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.
Read the detailed description
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.
- Conditions
- Chronic Migraine Without Aura, Intractable, Migraine With Typical Aura, Migraine Disorders
- Being tested
- Dexamethasone, Lidocaine, Thiamine cohort
- Keywords
- Migraine, Craniofacial Neuralgia
- Medical subject headings
- Migraine with Aura, Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone, Lidocaine, Thiamine cohortCombination product
Also called De-Novo Treatment Cohort medication
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Combination Product: Dexamethasone, Lidocaine, Thiamine cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 weeks
Secondary outcomes (1)
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study start1 Jul 2017
- Primary completion1 Jul 2018 (estimated)
- Study completion1 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Chronic Migraine Without Aura, IntractableStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective Open Label Study
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corona Doctors Medical Clinics, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Faro T. Owiesy, M.D., Principal investigator, Corona Doctors Medical Clinics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03220113
- Sponsor's protocol ID
- 2017/05/1
- Acronym
- Migraine
- Status last verified
- Jul 2017
- First submitted
- 11 Jul 2017
- Last updated
- 4 Apr 2018
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No sharing suggested at this time
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. doi: 10.1016/S1474-4422(07)70104-7.
PubMed 17434099Negovskii VA. [History of resuscitation in the USSR]. Vestn Akad Med Nauk SSSR. 1975;(12):26-9. No abstract available. Russian.
PubMed 775837Johri 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.
PubMed 10999594Morinville V, Jeannet-Peter N, Hauser C. Anaphylaxis to parenteral thiamine (vitamin B1). Schweiz Med Wochenschr. 1998 Oct 31;128(44):1743-4.
PubMed 9846348Van 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.
PubMed 7755837Wrenn KD, Murphy F, Slovis CM. A toxicity study of parenteral thiamine hydrochloride. Ann Emerg Med. 1989 Aug;18(8):867-70. doi: 10.1016/s0196-0644(89)80215-x.
PubMed 2757284De 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.
PubMed 704656Hayashi 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.
PubMed 1760726Shoeb 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.
PubMed 22067901Newman SP. Aerosol deposition considerations in inhalation therapy. Chest. 1985 Aug;88(2 Suppl):152S-160S. doi: 10.1378/chest.88.2_supplement.152s.
PubMed 3893925Yadav 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.
PubMed 20219672Yadav 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.
PubMed 19136698Tai 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.
PubMed 17481556Liu 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.
PubMed 15328374Rodriguez Melendez R. [Importance of water-soluble vitamins as regulatory factors of genetic expression]. Rev Invest Clin. 2002 Jan-Feb;54(1):77-83. Spanish.
PubMed 11995411
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03220113
- Acronym / sponsor ID
- Migraine / 2017/05/1
- Conditions
- Chronic Migraine Without Aura, Intractable, Migraine With Typical Aura, Migraine Disorders
- Keywords
- Migraine, Craniofacial Neuralgia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Corona Doctors Medical Clinics, Inc.University, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Jul 2018 (estimated)
- Study completion
- 1 Jul 2019 (estimated)
- First posted
- 18 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective Open Label Study
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone,Lidocaine,Thiamine cohort | Experimental | Combination Product: Dexamethasone, Lidocaine, Thiamine cohortSimultaneous 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. |
Who may qualify
- Ages
- 10 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- • Age: 10-90 years
Key exclusion criteria (8 listed)
- • Uncontrollable hypertension, acute Myocardial Infarct within last 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone, Lidocaine, Thiamine cohortAlso: De-Novo Treatment Cohort medicationBilateral 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. | Combination product | Dexamethasone,Lidocaine,Thiamine cohort |
Primary outcome
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.
1 secondary outcome
Assessment of the clinical response to the De-Novo treatment formula in study patients consisting of a lone composite measure
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2018.
- Background: PubMed 17434099Sechi 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.
- Background: PubMed 775837Negovskii VA. [History of resuscitation in the USSR]. Vestn Akad Med Nauk SSSR. 1975;(12):26-9. No abstract available. Russian.
- Background: PubMed 10999594Johri 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.
- Background: PubMed 9846348Morinville V, Jeannet-Peter N, Hauser C. Anaphylaxis to parenteral thiamine (vitamin B1). Schweiz Med Wochenschr. 1998 Oct 31;128(44):1743-4.
- Background: PubMed 7755837Van 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.
- Background: PubMed 2757284Wrenn KD, Murphy F, Slovis CM. A toxicity study of parenteral thiamine hydrochloride. Ann Emerg Med. 1989 Aug;18(8):867-70. doi: 10.1016/s0196-0644(89)80215-x.
- Background: PubMed 704656De 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.
- Background: PubMed 1760726Hayashi 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.
- Background: PubMed 22067901Shoeb 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.
- Background: PubMed 3893925Newman SP. Aerosol deposition considerations in inhalation therapy. Chest. 1985 Aug;88(2 Suppl):152S-160S. doi: 10.1378/chest.88.2_supplement.152s.
- Background: PubMed 20219672Yadav 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.
- Background: PubMed 19136698Yadav 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.
- Individual participant dataSharing planned: No. No sharing suggested at this time
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Faro T. Owiesy, M.D. principal investigator
Corona Doctors Medical Clinics, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Dexamethasone, Lidocaine, Thiamine cohort in people with Chronic Migraine Without Aura, Intractable and Migraine With Typical Aura, run by Corona Doctors Medical Clinics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Faro T. Owiesy, M.D. (9513719500, owiesymd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the safety to the De-Novo treatment formula in study patients (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03220113, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2018.