Treatment of Chronic Migraine Headaches.

Corona Doctors Medical Clinics, Inc.

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Migraine Disorders; Chronic Migraine Without Aura, Intractable; Migraine With Typical Aura

Treatments: Combination Product: Dexamethasone, Lidocaine, Thiamine cohort

Study type: Interventional

Funder types: Other

Identifiers

NCT03220113

2017/05/1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 10 to 90 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

100 participants in 1 patient group

Dexamethasone,Lidocaine,Thiamine cohort

Experimental group

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.

Treatment:

Combination Product: Dexamethasone, Lidocaine, Thiamine cohort