Middle Age Migraineurs At Risk Of Parkinson’s Later

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Studies Show Some Middle-Age Migraineurs Go On To Develop Parkinson’s At Old Age (1)

A recent study conducted at the Uniformed Services University in Bethesda, and published in the medical journal Neurology (of the American Academy of Neurology) , showed that there was a link between migraines and the development of Parkinson’s Disease.

Though severe migraine attacks are considered as disabling as serious illnesses such as dementia, active psychosis or even quadriplegia, it is still the most under-funded and less researched of all neurological diseases in the world.

As per lead author of the study, Ann I. Scher, M.D migraines are the most common brain disorder among both the sexes linked to both cerebrovascular and heart disease. However, the study exhibited that the link between middle-age migraining and Parkinson’s is stronger for women who suffer migraines with aura. She says, “This new possible association is one more reason research is needed to understand, prevent and treat the condition.” (2)

The research involved 5620 persons from Iceland for a period of 25 years. Their ages were between 33 and 65 years at the time when the study began. Of the 5620 persons studied, 1028 had headaches without migraine symptoms, 238 had migraines without aura and 430 experienced migraines with aura. Here are the result highlights:  (3)

  • Migraineurs with aura twice as likely to develop Parkinson’s later than Migraineurs without aura
  • 1% of the persons without headaches developed Parkinson’s later when compared to 2.4% who developed it and had migraines with aura.
  • People with migraine with aura were also around 3.6 times more likely to report at least four of the six symptoms of Parkinson’s, and people with migraine without aura were 2.3 times more likely.
  • Overall rates in absolute terms were as:
        • In people with migraine with aura: 19.7%
        • In people with migraine without aura: 12.6%
        • In people with no headaches at all: 7.5%.

According to Scher, “A dysfunction in the brain messenger dopamine is common to both Parkinson’s and Restless Leg Syndrome (RLS), and has been hypothesized as a possible cause of migraine for many years. Symptoms of migraine such as excessive yawning, nausea and vomiting are thought to be related to dopamine receptor stimulation.  More research should focus on exploring this possible link through genetic studies”

SOURCES

  1. Image Credit: Frustrated Caucasian Woman by Stock Images; Freedigitalphotos.net; Web October 2014; http://www.freedigitalphotos.net/images/Emotions_g96-Frustrated_Caucasian_Woman_p81435.html
  2. Link Found Between Migraine And Parkinson’s; Medical News Today; Web October 2014; http://www.medicalnewstoday.com/articles/282678.php
  3. Migraines In Middle Age, Parkinson’s Risk Later? WebMD.com; Web October 2014; http://www.webmd.com/migraines-headaches/news/20140917/are-migraines-in-middle-age-tied-to-raised-parkinsons-risk-later

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New Drugs Targeting CGRP Offer Hope: American Academy of Neurology

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Role Of CGRP and Antagonists In Migraine Attack (1)

CGRP is critically implicated in the occurrence and unfolding or progress of a migraine attack. CGRP or Calcitonin gene-related peptide is a powerful protein/peptide containing a short chain of amino acid monomers. It plays a critical role in transmitting pain signals through the body in events such as migraines. It is also involved in the vasodilation, inflammation, immune-modulatory responses among others during migraine attack apart from increasing heart beat and altering sensory transmission.

CGRP is produced by the peripheral and central neurons of our central nervous system specifically around the spinal cord and the trigeminal ganglion. Prior to and during migraine episodes, the central and peripheral neurons release more CGRP. This is then mediated through CGRP receptors (CALCRL and RAMP1) found throughout the body. One way to prevent pain from occurring is to block the receptors that receive the CGRP protein using a chemical/drug. Such drugs are called CGRP antagonists or CGRP blockers.

In a post of March 28th, 2012 I had written (‘CGRP Blockers & SRAs – The New Faces In Research For Migraine Management’) on work being done on drugs that targeted CGRP receptors but were abandoned after Phase III trials due to adverse reaction found in some of the trial population. (2).

Currently, two studies showing work with calcitonin receptor blockers have moved into Phase II trials. This means that though positive outcomes have been had from these researches involving smaller populations, larger studies are required to clear the drug for sale or prescription.

Research 1:

This involves a prospective drug that aims to prevent migraine from starting rather than trying to stop attack from progressing once it has begun. The drug involves monoclonal antibodies or antibodies that are identical immune cells – clones of their unique parent cell. Such monoclonal antibodies are being directed at the CGRP to target the protein.

This research examined 163 migraineurs for a period of six months, who had migraine attacks ranging anything from 5 -14 days every month. In this time, they gave the population either a placebo or the drug under study called ALD403 without the migraineurs knowing what they were taking. Those who took the drug reported a 66% reduction in number of migraine days and in 12 weeks time reported to be migraine-free.

As per lead author Peter Goadsby, MD, PhD, of the UC San Francisco and a member of the American Academy of Neurology, “These results may potentially represent a new era in preventive therapy for migraine. Migraine remains poorly treated, and there are few effective and well tolerated treatments approved that prevent attacks from occurring.” (3)

Research 2:

This potential drug in injectable form too is a preventative rather than a mitigator of migraine condition and is based on monoclonal antibodies targeting CGRPs. In Phase II trials as well, the research studied 217 migraineurs who experienced anything from 4-17 days of migraine days every month.

The population being observed was also administered either a placebo or the drug under study called LY2951742 via the subcutaneous injection route, without being told which was which for a period of three months. Those who were receiving the real drug reported more than 4 days less of migraine days in a month. However, they also experienced more side-effects such as abdominal pain and upper respiratory tract infections.

As per Dr. David Dodick, MD, of Mayo Clinic Arizona in Phoenix and a member of the American Academy of Neurology, “We’re cautiously optimistic that a new era of mechanism-based migraine prevention is beginning. There is a huge treatment need for migraine — the third most common and seventh most disabling medical disorder in the world” (4)

SOURCES:

  1.  Image Credit: The Role of CGRP and its Antagonists in Migraine- Peripheral Actions of CGRP: Neurogenic Inflammation;  Flipper.diff.org; Web April 2014; http://bit.ly/PsCR7O
  2. CGRP Blockers & SRAs – The New Faces In Research For Migraine Management; Web April 2014; https://migrainingjenny.wordpress.com/2012/03/28/cgrp-blockers-sras-the-new-faces-in-research-for-migraine-management/
  3. New drugs offer hope for migraine prevention; ScienceDaily News; Web April 2014; http://www.sciencedaily.com/releases/2014/04/140422162048.htm
  4. Stopping Migraines Before They Start; DailyRx.com; Web April 2014; http://www.dailyrx.com/migraine-patients-had-fewer-attacks-monoclonal-antibody-treatment

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FDA Approves Hi Tech Headband That Prevents Migraines

CEFALY

The Cefaly Headband That Prevents Migraines (1)

Engineers and pharmacists at STX-Med from Belgium have come up with a sophisticated electronic device that excites precisely the sensitive nerve cells to treat pain and motor neurons to obtain muscle contraction or treat muscle spasms. Known as the Cefaly, it has now been approved for sale in the US by the FDA. The device is already in usage among migraineurs in France, Canada, Australia and elsewhere. This external headband that offers neuro-stimulation is worn in particular to treat both migraines and tension headaches. (2)

The Cefaly is a battery-powered headband that emits electric currents to stimulate the nerves that are involved in migraine episodes. Tests on 67 patients have shown that this device reduces not only the total number of migraine attacks per month but also decreases the intensity of an attack.

The device is based on TENS (or Transcutaneous Electrical Nerve Stimulation) technology that has been studied in the medical circles for over four decades. The usage of TENS techniques is however, contraindicated under certain situations. (3)

The Cefaly device is meant to be administered on migraine patients and those with joint pains who are 18 years and older and for no longer than 20 minutes a day. The medical device is both CE and ISO certified for safety and performance as well as effectiveness.

It is believed to be 25% more effective than any other migraine management options available through prescription and is also effective in conditions such as insomnia and anxiety.

About 53 percent of 2,313 patients in a separate study said they were satisfied with the device and willing to purchase it for future use. (4)

For details of the study and a word from the doctors and developers, WATCH VIDEO: Migraine Relief Using New FDA-Approved Portable TENS Device ; Liberty Voice; Web March 2014; http://guardianlv.com/2014/03/migraine-relief-using-new-fda-approved-portable-tens-device/

SOURCES

  1. Image Credits: Cefaly Drug-Free Migraine Pain Relief; Cefaly; Web March 2014; http://www.cefaly.ca/
  2. FDA Approves Electric Headband to Prevent Migraine; ABC News; Web March 2014; http://abcnews.go.com/Business/wireStory/fda-approves-electric-headband-prevent-migraine-22866209
  3. FDA approves electric headband that prevents migraines; MedCity News; Web March 2014; http://medcitynews.com/2014/03/fda-approves-electric-headband-prevents-migraines/#ixzz2vj7F2HGq
  4. FDA Approves Electric Headband To Prevent Migraine; NPR; Web March 2014; http://www.npr.org/templates/story/story.php?storyId=289099411

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Cerena TMS Okayed For Sale On Prescription By FDA

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eNeura Therapeutics’ Transcranial Magnetic Stimulator (TMS) Now Available To Migraineurs With Aura (1)

US Food and Drug Administration (FDA) has allowed the marketing and sale on prescription eNeura Therapeutics device for the treatment and management of migraines. It has proved to be beneficial in pain mitigation for those whose migraine episodes are preceded by aura. Prior to awarding of approval, the FDA studied both at pre-market data as well as results of clinical trials of the device on migraineurs with aura. (2)

The device is essentially a transcranial magnetic stimulator (TMS). The Cerena TMS is to be held against the back of the migraineur’s head and turned on by the push of a button. The device releases short pulses of magnetic waves to stimulate the occipital cortex of the migraineur’s brain which in turns either ceases pain or reduces the intensity of pain. The device does not relive any other symptom associated with migraines such as photo or sound sensitivity, nausea etc. (3)

Though classified as a low-moderate risk device, it is not to be used by those suffering from epilepsy and not more than once every 24 hours even by those who are prescribed the use of the TMS. The transcranial magnetic stimulator is not recommended for those patients who have any type of implants especially magnetic metals in the head, neck or upper body, pacemakers, deep brain stimulators etc.

Randomized controlled trials on some 201 patients showed that approximately 38% of those using the TMS device were free of any pain in two hours after administration compared to 17% of controls.

SOURCE

  1. Image Credit: The Transcranial Magnetic Stimulator by eNeura Therapeutics ; Electronicproducts.com; Web December 2013; http://www.electronicproducts.com/Passive_Components/Magnetics_Inductors_Transformers/FDA_approves_pulsating_magnetic_device_to_help_ease_headaches.aspx
  2. First device to treat migraine wins FDA approval; MedicalNewsToday.com; Web December 2013; http://www.medicalnewstoday.com/articles/270233.php
  3. FDA approves pulsating magnetic device to help ease headaches; Hearst Electronic Prodcuts; Web December 2013; http://www.electronicproducts.com/Passive_Components/Magnetics_Inductors_Transformers/FDA_approves_pulsating_magnetic_device_to_help_ease_headaches.aspx

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Superior Acute Migraine Treatment Through Transcept & SNBL Deal

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New drug combines combines a muco-adhesive drug carrier of active DHE with a proprietary nasal powder drug delivery device (1)

A new drug that is poised as a rapidly absorbed chemical in the treatment of acute migraines is now on the horizon. The principal or active chemical in the new drug is dihydroergotamine or DHE.

It is anticipated that DHE which for patenting process is known as TO-2070 will provide a novel and potentially improved approach to treatment of acute migraines in patients. TO-2070 is based on a novel nasal powder drug delivery technology. The technology which is developed by Shin Nippon Biomedical Laboratories (SNBL) combines a muco-adhesive drug carrier with a proprietary nasal powder drug delivery device.

Actually DHE is a well-known treatment for treatment of acute migraines and is being used in the US since 1946, however its delivery via the liquid nasal spray route, the subcutaneous route, via intramuscular injections or intravenous shots is hindered by inconvenient administration regimen, slow onset of relief, inconsistent absorption, post-nasal drip and bitter taste. DHE delivery via the pulmonary inhalation method has still not obtained a nod from FDA.

As per the preclinical data this new drug could offer a considerable range of benefits to the migraineur. Such benefits as are not provided by the currently available delivery methods such as injections, pulmonary inhalation etc which prove more inconvenient as well as invasive by nature. (2)

Both Transcept and SNBL have announced that they have entered into an exclusive global licensing agreement. Transcept will pay SNBL an upfront fee, charges through the developmental milestones of the drug as well as following launch and commercialization. This deal will provide Transcept with an advanced nasal powder delivery device and preclinical and clinical services to support the development of TO-2070.

According to Alan Rapoport, M.D., Clinical Professor of Neurology at the David Geffen School of Medicine at UCLA, Los Angeles, CA, and President of the International Headache Society, “DHE has proven to be an excellent treatment for many of the migraine patients who have tried it. This medication can work quickly depending on how it is administered, provides long-lasting relief, has demonstrated a low migraine recurrence rate and can be effectively administered late in the migraine process. Despite these important advantages, the therapeutic impact of DHE has been somewhat limited by challenges associated with the effective delivery of the drug. With this in mind, a novel delivery system that enables the administration of DHE in a convenient way and offers patients rapid and sustained migraine relief, would represent an important advance in the treatment of migraine.” (3)

SOURCES

  1. Image Credits: File:Dihydroergotamine.svg; Wikipedia.com – Wikipmedia Commons; Web September 2013; http://en.wikipedia.org/wiki/File:Dihydroergotamine.svg
  2. Transcept, SNBL Sign Global Licensing Deal For Advanced Acute Migraine Treatment; RTT News; Web September 2013; http://www.rttnews.com/2193740/transcept-snbl-sign-global-licensing-deal-for-advanced-acute-migraine-treatment.aspx?type=bn
  3. Transcept And Shin Nippon Biomedical Laboratories Announce Global Licensing Agreement For Advanced Acute Migraine Treatment; Market Watch – The Wall Street Journal; Web September 2013; http://www.marketwatch.com/story/transcept-and-shin-nippon-biomedical-laboratories-announce-global-licensing-agreement-for-advanced-acute-migraine-treatment-2013-09-25

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Cocktail Vitamin Pill To Treat Migraine To Hit Market Soon: Australia

Vitamin Pill Migraine Photo

Now B vitamins and folate combo to improve enzymes connected to migraines (1)

Australian scientists are in the final stages of testing a pill which could help as many as 20% of all migraine sufferers in the country.

It has been noted that migraineurs often have a mutation in the gene called MTHR (or Methylene Tetra-Hydrofolate Reductase). Due to this mutated gene, there exists a deficiency in the enzyme that the gene is responsible for releasing. This enzyme is actually responsible for regulating levels of folate and homocysteine in the body.

But because there are low levels of the enzyme released due to the mutation of the gene, homocysteine levels cannot be controlled efficiently leading to migraines, increased risk of stroke and cardiovascular disorder.

However, the new pill undergoing final stages of trials, is essentially a cocktail of folate and B vitamins and is being seen to improve the functionality of the enzyme that regulates homocysteine levels

As per lead researcher Professor Lyn Griffiths who is also heading a new unit at the Queensland University of Technology that is investigating gene mutations linked to migraines and other chronic illnesses, “A cofactor for the enzyme is vitamins and we’ve done a phase-one and phase-two trial that showed they could make the enzyme work better.” (2)

The final rounds of phase-three trial include some 600 migraine sufferers to test the efficacy of the pill. Though the pill does not claim that it will cure migraines, especially in those without the gene mutation, it does assure that it will reduce both their frequency as well as the severity of the pain in those who do carry the mutation MTHR.

Note:

Migraine sufferers who want to find out if they have the MTHR gene mutation can have a blood sample taken and sent to the university for a $66 DNA test. Professor Griffiths is urging people who suffer from migraine to join the Headache Register at headacheaustralia.org.au. The site allows sufferers to access the latest in migraine news and research, learn about current and upcoming treatment trials and download a Headache Diary to help them manage their disorder.

SOURCES

  1. Image Credit: Young Female Having Headache by imagerymajestic; freedigitalphotos.net; Web September 2013; http://www.freedigitalphotos.net/images/Emotions_g96-Young_Female_Having_Headache_p74906.html
  2. Hopes vitamin pill will ease crippling migraines; News.com.au; Web September 2013; http://www.news.com.au/lifestyle/health/hopes-vitamin-pill-will-ease-crippling-migraines/story-fneuzlbd-1226721310920

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Peak Bio-availability in 2-3 Minutes: Aegis Awarded 3rd Patent for Intravail(R)

Aegis Therapeutics LLC

Aegis’ Non-Invasive Drug Delivery System For Migraines (1)

Aegis Therapeutics LLC, the developers of drug delivery and drug formulation technologies has announced that it has received it’s 3rd patent for fast acting formulations of triptans, a widely used class of drugs including Sumatriptan, Zolmitriptan, Naratriptan, Rizatriptan, Eletriptan, Almotriptan and Frovatriptan. The total triptan class of drugs has a market of over $3 billion of which Sumatriptan alone accounts for $2 billion.

Trials on humans have demonstrated that the now patented Intravail® formulation of sumatriptan is bioavailable in 2-3 minutes of administration.  This is a 20-30 times faster achievement of therapeutic drug levels than what is currently marketed non-invasive/non-injectable sumatriptan products. (2)

The most common triptan formulations currently available commercially – the oral tablet and the nasal spray reach peak blood level concentration of the drug in 60-120 minutes – many times slower than Intravail® formulation of sumatriptan and thus delaying onset of pain relief.

The new technology – Intravail® formulation of sumatriptan is widely applicable to other small molecule as well as biotherapeutic drugs that step up

The enabling Aegis Intravail formulation technology is broadly applicable to a wide range of small molecule and biotherapeutic drugs to increase noninvasive bioavailability by the oral, nasal, buccal, and sublingual routes especially in those cases where speed is important to the patient. Acute symptoms and A&E cases with severe pain, nausea, emesis, convulsive disorders, spasticity is expected to be greatly helped by the new Intravail® formulation of sumatriptan by Aegis Therapeutic LLC.

SOURCE:

  1. Image credits: Aegis Therapeutics LLC; Web August 2013; http://aegisthera.com/
  2. Aegis Awarded 3rd Patent for Fast Acting Migraine Nasal Spray Treatment; Aegis Therapeutics LLC; Web August 2013; http://aegisthera.com/aegis-awarded-3rd-patent-for-fast-acting-migraine-nasal-spray-treatment/

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