Prophylaxis and mitigation of migraine headaches using medium chain triglycerides, ketone ester, and other ketonic sources

Abstract

A composition comprising a dietary ketone, wherein the dietary ketone is designed to reduce migraine symptoms in a patient experiencing migraines and related method of manufacture and use are also disclosed.

Description

RELATED APPLICATIONS[0001]This is a divisional of U.S. application Ser. No. 15 / 743,448 entitled “Prophylaxis and Mitigation of Migraine Headache Using Medium Chain Triglycerides Ketone Esters, and Other Ketogenic” filed on Jan. 10, 2018, which has now been granted a Notice of Allowance.FIELD OF THE INVENTION[0002]The invention relates to migraine headaches, sometimes simply called migraine. More particularly, the invention relates to preventing, arresting, or reducing the frequency or severity of migraine.BACKGROUND OF THE INVENTION[0003]Migraine is a neurological disease with a strong genetic component. It is characterized by episodes of disabling headache, often called migraine attacks. They are clinically quite different from regular headaches which are non-migrainous. There are about 100 million people with headaches in the U.S. and about 37 million of these people have migraines. The World Health Organization estimates that approximately 18 percent of Women and 7 percent of men...

AI Technical Summary

Benefits of technology

[0019]The invention provides effective, safer treatments to prevent or reduce frequency of migraine onset and reduce migraine symptoms. The present inventors have surprisingly discovered that providing ketogenic medium chain triglycerides (KMCT) to patients suffering from frequent migraine attacks can reduce frequency of migraine onset and reduce migraine symptoms, without the side effects of medications currently used for this purpose. KMCT are metabolized in the liver to provide a rich source of ketone bodies, which can be metabolized as a carbon and energy source for the body, especially the brain. Unlike ketogenic dieting, providing exogenous KMCT does not result in reduced glucose concentrations or other physiological effects associated with ketogenic dieting, and does not suffer from similar patient compliance issues. Ingestion of KMCT has no reported serious side effects and only minor and transitory reported effects of gastro-intestinal distress or sensitivity in some users, which has been shown to usually diminish with continued use.

[0020]In one embodiment of the invention provides a method for preventing or reducing the frequency of migraine onset in a migraineur. The method according to this aspect of the invention comprises providing the migraineur with dietary KMCT.

[0021]In another embodiment, the invention provides a method for reducing the migraine symptoms experienced by a migraineur. The method according to this aspect of the invention comprises providing the migraineur with dietary KMCT.

Problems solved by technology

Some cause pain on just the right side or left side of the head (hemicrania), others result in generalized head pain.

Migraine sufferers may have moderate or severe pain and usually can't participate in normal activities during the duration of the attack, because of the pain.

Often when a migraine strikes, people can't think beyond trying to find a quiet, dark room.

All of these treatments, however, with increased frequency of use can lead to a condition called medication overuse headache (MOH).

Medication-overuse headaches occur when medications not only stop relieving pain but themselves also cause headaches.

Patients then use more pain medication, which may lengthen the duration of pain of the migraine sufferer.

In addition, these treatments pose additional, specific risks such as drug sensitivities, cognitive symptoms and negative physiological effects, some of which are further elucidated below.

Unfortunately, regular use of these medications can result in abdominal pain and intestinal ulcers-often associated with hemorrhage, and they are generally not effective against more severe migraine.

Side effects of ergotamines include dizziness, nausea and vomiting, cold, clammy hands and feet, muscle pain, numbness, and feelings of discomfort or anxiety.

Glucocorticoids, such as prednisone and dexamethasone may be used in conjunction with other medications to improve pain relief Because of the risk of adverse side effects, glucocorticoids should not be used frequently or for prolonged periods, which presents problems for chronic migraneurs.

Unfortunately, beta blockers produce their own, often severe side effects, including fatigue, nausea, reduced ability to exercise, insomnia, sleep problems, nightmares and vivid dreams, memory problems, depression, weight gain, and exacerbation of asthma.

However, these drugs carry their own side effect profile, including dizziness, drowsiness, constipation, nausea, headache, rash, pitting edema of the feet, ankles and lower legs (owing to water retention), low blood pressure, tachycardia (rapid heartbeat), and flushing (reddening) of the face, neck and / or upper chest.

Unfortunately, these drugs have a wide range of undesirable side effects, including disturbances in heart rhythm, increased sensitivity to sunlight, drowsiness, dry mouth, painful urination, sexual dysfunction, weight gain, dizziness, lightheadedness, and headaches.

In addition, antidepressants come with the U.S. Food and Drug Administration's strongest “black box” warning that the use of antidepressants has been associated with an increased risk of suicidal thoughts and behaviors in children, adolescents and young adults.

Tricyclic antidepressants can be fatal in overdose.

However, some anticonvulsant medications may reduce the effectiveness of oral contraceptives, since their induction of the hepatic cytochrome P450 (CYP45 0) isoenzyme causes decreased sex hormone levels in women taking oral contraceptives, thus raising the potential for decreased effectiveness of oral contraceptives and increased risk of unplanned pregnancy.

Some people who take newer drugs in this class also experience swelling in the feet and hands, weight gain, blurry vision, trouble concentrating, and lapses in memory.

However, Botox's side effects include headache, facial loss of movement, eyelid drooping, lung inflammation, neck pain, muscle stiffness and weakness, muscle pain and spasms, pain at injection site, and high blood pressure.

In addition, the paralyzing effect of Botox can spread to other areas of the body and can cause general weakness, double vision, difficulty swallowing, voice and speech disorders, loss of bladder control and difficulty breathing.

However, some authors have described ketogenic dieting as potentially causing severe headaches, and low glucose levels, among a number of other physiological effects of ketogenic dieting, which might complicate its use.

In addition, adherence to a ketogenic diet can be difficult and compliance problems frequently arise.