MedTrace Logo

Treatment of Chronic Migraine Headaches.

NCT03220113 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2018-04-04

No results posted yet for this study

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.

Conditions

  • Chronic Migraine Without Aura, Intractable
  • Migraine With Typical Aura
  • Migraine Disorders

Interventions

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.

Sponsors & Collaborators

  • Corona Doctors Medical Clinics, Inc.

    lead OTHER

Principal Investigators

  • Faro T. Owiesy, M.D. · Corona Doctors Medical Clinics, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
10 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-01
Primary Completion
2018-07-01
Completion
2019-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03220113 on ClinicalTrials.gov