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

No Placebo-Only Group

All Individual Drugs Already Approved

Approved for 60 Other Conditions

Summary

This trial tests a new treatment for people with chronic migraines and facial pain that haven't responded to other treatments. The treatment involves injecting a mix of a steroid, a pain reliever, and a vitamin into specific nerves in the head and neck. This combination aims to reduce overactive pain signals and provide long-term relief.

Eligible Conditions

Migraine

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Assessment of the safety to the De-Novo treatment formula in study patients

Secondary study objectives

Assessment of the clinical response to the De-Novo treatment formula in study patients consisting of a lone composite measure

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 60 Other Conditions

This treatment demonstrated efficacy for 60 other conditions.

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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