Treatment of Chronic Migraine Headaches. (Migraine)
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|ClinicalTrials.gov Identifier: NCT03220113|
Recruitment Status : Recruiting
First Posted : July 18, 2017
Last Update Posted : April 4, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Migraine Without Aura, Intractable Migraine With Typical Aura Migraine Disorders||Combination Product: Dexamethasone, Lidocaine, Thiamine cohort||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Prospective Open Label Study|
|Masking:||None (Open Label)|
|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.|
|Actual Study Start Date :||July 1, 2017|
|Estimated Primary Completion Date :||July 1, 2018|
|Estimated Study Completion Date :||July 1, 2019|
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.
Combination Product: 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.
Other Name: De-Novo Treatment Cohort medication
- Assessment of the safety to the De-Novo treatment formula in study patients [ Time Frame: 5 weeks ]Study assesses the safety of the De-Novo algorithm( if patients who receive this treatment will experience any major adverse reactions due to the medication combination )within the next 5 weeks following treatment. Participants will be interviewed after the initial treatment weekly, for 5 weeks to evaluate for any possible adverse events, hospitalization, or treatment. Any significant adverse event in over 45% of participants, may project end of the trial.
- Assessment of the clinical response to the De-Novo treatment formula in study patients consisting of a lone composite measure [ Time Frame: 12 months ]
Assessment of the clinical response to the De-Novo treatment formula in study patients.
Study assesses the efficacy parameters of the study ( i.e. the change in baseline frequency of migraine attack in patients post initial treatment ), and functionality status based on continuation of work performance and return to work or school.
Therefore, the Outcome of study consisting of multiple measures and present lone composite measure.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03220113
|Contact: Faro T. Owiesy, M.D.||email@example.com|
|Contact: Jovana Martin Murillofirstname.lastname@example.org|
|United States, California|
|Corona Doctors Medical Clinics Inc||Recruiting|
|Corona, California, United States, 92879|
|Contact: Faro T Owiesy 951-371-9500 email@example.com|
|Contact: Jovana Martin Murillo 9513719500 firstname.lastname@example.org|
|Principal Investigator: Faro T Owiesy, MD|
|Principal Investigator:||Faro T. Owiesy, M.D.||Corona Doctors Medical Clinics, Inc.|