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Corticosteroid
Dexamethasone,Lidocaine,Thiamine cohort for Migraine (Migraine Trial)
Phase 1 & 2
Waitlist Available
Led By Faro T. Owiesy, M.D.
Research Sponsored by Corona Doctors Medical Clinics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Migraine 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 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.
Eligible Conditions
- Migraine
Migraine Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Assessment of the safety to the De-Novo treatment formula in study patients
Secondary outcome measures
Assessment of the clinical response to the De-Novo treatment formula in study patients consisting of a lone composite measure
Migraine Trial Design
1Treatment groups
Experimental Treatment
Group I: Dexamethasone,Lidocaine,Thiamine cohortExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
Corona Doctors Medical Clinics, Inc.Lead Sponsor
1 Previous Clinical Trials
5 Total Patients Enrolled
Faro T. Owiesy, M.D.Principal InvestigatorCorona Doctors Medical Clinics, Inc.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What state do they live in?
California
How old are they?
65+
What site did they apply to?
Corona Doctors Medical Clinics Inc
What portion of applicants met pre-screening criteria?
Met criteria
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