Clinical trial NCT03220113: Treatment of Chronic Migraine Headaches.
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
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Chronic Migraine Without Aura, Intractable
Migraine With Typical Aura
Migraine Disorders
Keywords: Migraine
Craniofacial Neuralgia
Lead sponsor: Corona Doctors Medical Clinics, Inc.
Sponsor class: OTHER
First posted: 2017-07-18
Enrollment: 100
Sex: ALL
Minimum age (years): 10
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective Open Label Study
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Assessment of the safety to the De-Novo treatment formula in study patients
timeFrame: 5 weeks
Secondary outcomes:
measure: Assessment of the clinical response to the De-Novo treatment formula in study patients consisting of a lone composite measure
timeFrame: 12 months
Other outcomes:
Locations:
city: Corona
country: United States
facility: Corona Doctors Medical Clinics Inc
state: California
Study officials:
affiliation: Corona Doctors Medical Clinics, Inc.
name: Faro T. Owiesy, M.D.
role: PRINCIPAL_INVESTIGATOR
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