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Treatment of Chronic Migraine Headaches. (Migraine)

Primary Purpose

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

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Dexamethasone, Lidocaine, Thiamine cohort
Sponsored by
Corona Doctors Medical Clinics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Migraine Without Aura, Intractable focused on measuring Migraine, Craniofacial Neuralgia

Eligibility Criteria

10 Years - 90 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Corona Doctors Medical Clinics IncRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dexamethasone,Lidocaine,Thiamine cohort

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 11, 2017
Last Updated
April 2, 2018
Sponsor
Corona Doctors Medical Clinics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03220113
Brief Title
Treatment of Chronic Migraine Headaches.
Acronym
Migraine
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
July 1, 2018 (Anticipated)
Study Completion Date
July 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Corona Doctors Medical Clinics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Migraine Without Aura, Intractable, Migraine With Typical Aura, Migraine Disorders
Keywords
Migraine, Craniofacial Neuralgia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Prospective Open Label Study
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dexamethasone,Lidocaine,Thiamine cohort
Arm Type
Experimental
Arm Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Dexamethasone, Lidocaine, Thiamine cohort
Other Intervention Name(s)
De-Novo Treatment Cohort medication
Intervention Description
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.
Primary Outcome Measure Information:
Title
Assessment of the safety to the De-Novo treatment formula in study patients
Description
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.
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
Assessment of the clinical response to the De-Novo treatment formula in study patients consisting of a lone composite measure
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Faro T. Owiesy, M.D.
Phone
9513719500
Email
owiesymd@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jovana Martin Murillo
Phone
9513719500
Email
coronadoctors@aol.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Faro T. Owiesy, M.D.
Organizational Affiliation
Corona Doctors Medical Clinics, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Corona Doctors Medical Clinics Inc
City
Corona
State/Province
California
ZIP/Postal Code
92879
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Faro T Owiesy
Phone
951-371-9500
Email
owiesymd@gmail.com
First Name & Middle Initial & Last Name & Degree
Jovana Martin Murillo
Phone
9513719500
Email
coronadoctors@aol.com
First Name & Middle Initial & Last Name & Degree
Faro T Owiesy, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No sharing suggested at this time
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Treatment of Chronic Migraine Headaches.

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