Recruiting
Phase 1
Phase 2

Chronic Migraine

Sponsor:

Corona Doctors Medical Clinics, Inc.

Code:

NCT03220113

Conditions

Chronic Migraine Without Aura, Intractable

Migraine With Typical Aura

Migraine Disorders

Eligibility Criteria

Sex: All

Age: 10 - 70+

Healthy Volunteers: Not accepted

Interventions

Dexamethasone, Lidocaine, Thiamine cohort

Study Details

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.

Conditions

Chronic Migraine Without Aura, Intractable

Migraine With Typical Aura

Migraine Disorders

Study ID

NCT03220113

Start date

Jul 1, 2017

Status verified date

Jul, 2017

Completion date

Jul 1, 2019

Anticipated

Primary completion date

Jul 1, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Assessment of the safety to the De-Novo treatment formula in study patients [ Time Frame: 5 weeks ]

Central Contacts and Locations

Central contacts

Faro T. Owiesy, M.D.

9513719500owiesymd@gmail.com

Jovana Martin Murillo

9513719500coronadoctors@aol.com

Locations

Corona Doctors Medical Clinics Inc

Recruiting

Corona, California, United States, 92879

Contacts

Faro T Owiesy

951-371-9500owiesymd@gmail.com

Jovana Martin Murillo

9513719500coronadoctors@aol.com

Principal Investigator:

Faro T Owiesy, MD

More Information

Sponsor

Corona Doctors Medical Clinics, Inc.

Last update posted

Apr 4, 2018

Last verified

Jul, 2017

Keywords

  • Migraine
  • Craniofacial Neuralgia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Corona Doctors Medical Clinics, Inc. on 2018-04-04.