Migraine Disorders Clinical Trial
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.
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.
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.
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