Treatment of Chronic Migraine Headaches.
Status unconfirmed · Phase 1/Phase 2
Conditions studied: Chronic Migraine Without Aura, Intractable, Migraine With Typical Aura, Migraine Disorders
In brief
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.
Key facts
- Study ID
- NCT03220113
- Run by
- Corona Doctors Medical Clinics, Inc.
- People needed
- 100
- Starts
- 2017-07-01
- Expected to finish
- 2019-07-01
- Last updated by the study team
- 2018-04-04
Who can join
Age: 10 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- • 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.
You may not qualify if…
- • 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.
Where it is running
- Corona Doctors Medical Clinics Inc — Corona, California, United States (enrolling)
Full record on ClinicalTrials.gov
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