Treatment of Chronic Migraine Headaches. (Migraine)

April 2, 2018 updated by: Corona Doctors Medical Clinics, Inc.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Corona, California, United States, 92879
        • Recruiting
        • Corona Doctors Medical Clinics Inc
        • Contact:
        • Contact:
        • Principal Investigator:
          • Faro T Owiesy, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 90 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • • 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.

Exclusion Criteria:

  • • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Dexamethasone,Lidocaine,Thiamine cohort

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.
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.
Other Names:
  • De-Novo Treatment Cohort medication

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of the clinical response to the De-Novo treatment formula in study patients consisting of a lone composite measure
Time Frame: 12 months

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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corona Doctors Medical Clinics, Inc.

Investigators

  • Principal Investigator: Faro T. Owiesy, M.D., Corona Doctors Medical Clinics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2017

Primary Completion (ANTICIPATED)

July 1, 2018

Study Completion (ANTICIPATED)

July 1, 2019

Study Registration Dates

First Submitted

July 11, 2017

First Submitted That Met QC Criteria

July 14, 2017

First Posted (ACTUAL)

July 18, 2017

Study Record Updates

Last Update Posted (ACTUAL)

April 4, 2018

Last Update Submitted That Met QC Criteria

April 2, 2018

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017/05/1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No sharing suggested at this time

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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