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Treatment of Chronic Migraine Headaches. (Migraine)

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ClinicalTrials.gov Identifier: NCT03220113
Recruitment Status : Recruiting
First Posted : July 18, 2017
Last Update Posted : April 4, 2018
Sponsor:
Information provided by (Responsible Party):
Corona Doctors Medical Clinics, Inc.

Tracking Information
First Submitted Date  ICMJE July 11, 2017
First Posted Date  ICMJE July 18, 2017
Last Update Posted Date April 4, 2018
Actual Study Start Date  ICMJE July 1, 2017
Estimated Primary Completion Date July 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 14, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03220113 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 14, 2017)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Chronic Migraine Headaches.
Official Title  ICMJE Safety and Efficacy of De-Novo Algorithm and Formula in the Treatment of Patients With Intractable Chronic Craniofacial Neuralgia, or Chronic Migraine Headaches.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
Prospective Open Label Study
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Migraine Without Aura, Intractable
  • Migraine With Typical Aura
  • Migraine Disorders
Intervention  ICMJE 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 Name: De-Novo Treatment Cohort medication
Study Arms  ICMJE 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.

Intervention: Combination Product: Dexamethasone, Lidocaine, Thiamine cohort
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 14, 2017)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2019
Estimated Primary Completion Date July 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 90 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Faro T. Owiesy, M.D. 9513719500 owiesymd@gmail.com
Contact: Jovana Martin Murillo 9513719500 coronadoctors@aol.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03220113
Other Study ID Numbers  ICMJE 2017/05/1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No sharing suggested at this time
Responsible Party Corona Doctors Medical Clinics, Inc.
Study Sponsor  ICMJE Corona Doctors Medical Clinics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Faro T. Owiesy, M.D. Corona Doctors Medical Clinics, Inc.
PRS Account Corona Doctors Medical Clinics, Inc.
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP