(Ivanhoe Newswire) –For some, it’s the feeling of tiny knives being jabbed into their heads. Others describe it as an hours-long, pounding and throbbing. Still for some, it’s a constant pain that even medication can’t relieve. For more than 29 million Americans, migraines are disabling. A 2009 study of medical insurance claims found that 20 percent of the opioids (some of the strongest pain medicines available) prescribed in the U.S are given to relieve the pain of migraines and headaches. Those pills not only come with dangerous side effects, but can lead to prescription pill addiction. We talked with experts from the Cleveland Clinic and the University of California to find out the latest in migraine research, and the cutting edge treatments that could soon be available.
“Stimulating” Migraine Pain
From cold therapies to Botox, there are numerous options available for migraine sufferers, but Dr. Frank Papay, Chairman of the Dermatology & Plastic Surgery Institute at Cleveland Clinic says one of the most effective treatments he’s seen isn’t even available in the U.S.
About three years ago, Dr. Papay and a team of neurologists, neurosurgeons, and pain therapists began working with California company, Autonomic Technologies™ Inc. (ATI), on a tiny implantable neurostimulator. Much like cardiac pacemakers (which send rhythmic electrical impulses to the heart to regulate its beat) the device sends impulses to the nerves to control head pain. The neurostimulator device can be implanted behind the cheekbone, where it will not be seen or felt by the patient. The implant procedure leaves no external scars.
“When you have a headache, the brain itself perceives pain but does not have pain fibers. The covering of the brain and the blood vessels within the covering on the brain have pain receptors. When you get a headache, it is a headache not on the brain itself but on these pain fibers.” Dr. Papay told Ivanhoe.
Clinical trials, which are being conducted in Europe, have shown encouraging results in cluster headache. Interim results from a randomized controlled study demonstrated pain relief in 59% of headaches treated. An important additional finding was a greater than 50% reduction in headache frequency in 63% of patients treated. Dr. Papay says it could be a great alternative to headache medication.
“You can minimize the risks associated with the medications people are taking, like Imitrex, that have adverse effects on the liver and heart. We like to think that these neurostimulators act like an “electronic” Imitrex and will hopefully mitigate the risks of the medications given to patients and that it may also prevent headaches from reoccurring,” Dr. Papay said.
Until recently, the device had only been tested in people with cluster headaches or “suicide headaches,” which are the worst kinds of headaches. In February, researchers initiated a trial in Europe to evaluate the same device for the treatment of severe migraine headaches. The trials are ongoing, but Dr. Papay says depending on the results overseas they could begin to be implemented in the U.S as early as within the next one to two years. Based on what he’s seen so far, he says the device has the potential to revolutionize the treatment of headaches worldwide.
“The initial results of this therapy are very promising and indicate that the therapy may be as effective as some acute medication to treat cluster headaches. The difference being, medication like Imitrex have limitations on the amount one can take, were as neurostimulation is not limited on how much can be applied. The therapy is still in experimental trials. Dr. Papay concluded.
Not everyone is a good candidate for the stimulator. Dr. Papay says those with tension headaches may find more effective treatment with the help of Botox.
Happening Now: In the Pipeline
Other options that could soon be available to migraineurs are medicines called calcitonin gene-related peptide (CGRP) receptor antagonists. Tests show the drugs are highly effective. During migraine attacks, CGRP binds to and activates CGRP receptors, which help transmit pain impulses. The new medicines stop CGRP from binding to its receptors and are believed to prevent the transmission of the pain signals that lead to migraine headaches.
One such oral version of the drug known as Telcagepant almost made it to general use, but was stopped after a small number of patients reported problems with their liver. Similar drugs, without that problem, are currently being tested. Early results show that each of the new oral CGRP blocker medicines works well to reduce pain and nausea, and has less severe side effects than triptans, which are the current standard treatments for acute migraine. While triptans are effective, there is a chance they could constrict blood vessels in the heart, causing severe problems. Dr. Peter Goadsby, of the Headache Group in the department of neurology at the University of California, San Francisco, says several companies have demonstrated that CGRP blockers do not have the blood vessel effects that the triptans have.
“So this is a way for it to be effective and adds a safety bonus to the patients and it seems to be better tolerated,” Peter Goadsby, MD, PhD, director of UCSF’s Headache Center told Ivanhoe.
Another drug in the pipeline is Lasmiditan. The drug is in a new class of drugs known as ditans, which are serotonin receptor agonists. Like CGRP blockers, the advantage of Lasmiditan is that it doesn’t seem to constrict blood vessels, and there have been no reports of cardiovascular effects. Recent trials showed significant improvement in migraine patients over a placebo. Within a two hour period, more than 60% of headaches were reduced to nothing or almost nothing. Nausea and sensitivity to light and sound were also significantly reduced over a longer period of time.
The company testing Lasmiditan, CoLucid, is planning trials throughout the next two years and is hoping to have a product ready for 2014. While an earlier drug in this class worked in the clinical trial, there was a legal problem with liver toxicity.
“Lasmiditan is now that finished its phase two studies and clearly works. It does not have the same sort of liver effects as its predecessors and will move on into phase three. That is again for acute migraine treatment. So it is a safe and totally different action than what we currently have,” Dr. Goadsby said.
Aspirin through IV’s. The Answer to Migraine Over medication?
In addition to throbbing head pain, another often-overlooked problem many chronic migraine sufferers face is medication overuse. One study found one in five migraine patients is prescribed opioids such as oxycontin, vicodin and percocet, and barbiturates such as fioricet. Patients who experience migraine pain at least 15 days a month, could be taking upward of 15 opioids every 30 days. When these patients take painkillers too often, it can lead to frequent or daily headaches known as medication-overuse headaches. Research out of the University of California, San Francisco, shows that taking aspirin intravenously through an IV bag could be of huge benefit to this group of migraine sufferers.
“I’m using this on people who have migraines for more than 15 days a month, who have problems with medication overuse,” Dr. Goadsby explained. “If you have got bad migraines and you are taking an opioid every day and you stop taking that, you get some pretty bad headaches. It is a way of relieving that for people who have that problem. How many people in the United States have got chronic migraines? Millions. How many people have medication overuse? Probably the same number, a million, or north of that.”
Dr. Goadsby found that aspirin given intravenously is a safe and effective way to treat hospitalized patients suffering from migraines or severe headaches. He says delivering aspirin through an IV drip is easily as effective as opioids like oxycodone, or oxycontin, only it is not sedating and not addictive. Intravenous aspirin is not readily available in the United States. It is typically an option for patients in Europe, Dr. Goadsby says he’s been using the method in his inpatient program for years.
“I think we are probably the only people in the U.S who are using it. It is very effective and well tolerated. There are ways of using these things on an individual basis. We use it every week, more or less,” Dr. Goadsby said.
As for why more doctors aren’t administering it in the U.S, Dr. Goadsby says it all boils down to experience.
“It’s typically something you have to have experience to use. You have to be convinced it is effective and you have to be familiar with the use and safety of it. So if you have not used it I can see why people practicing in the U.S would find it a difficult step to take into the unknown so to speak,” Dr. Goadsby said.
Dr. Goadsby says this method is ideal for people who suffer from chronic migraines and are using an opioid ten days or more per month to treat them. Since the aspirin is introduced intravenously the patients get the maximum benefit of the painkiller, and feel the effects much quicker. There are no additional side effects when taking it intravenously, and it is not a good option for people who have sensitivity to aspirin.
“If the will is there, it could easily be available because aspirin itself is a hundred years old. It’s not like it got invented last week. You hope people can take the big picture and see that it is something that is well established and beneficial for patients and that there will be a way to work with the legislative body to facilitate its use,” Dr. Goadsby added.
From intravenous aspirin, to stimulators, to new drugs with promise, much-needed relief could be just around the corner for millions of migraine sufferers across the country.
Institute of Medicine Report from the Committee on Advancing Pain Research, Care, and Education: Relieving Pain in America, A Blueprint for Transforming Prevention, Care, Education and Research. The National Academies Press, 2011.
Results from the 2009 National Survey on Drug Use and Health (NSDUH): National Findings, SAMHSA (2010).
Summary Health Statistics for U.S. Adults: National: Health Interview Survey, 2009, Department of Health and Human Services Report (page 7)
- Vital Signs: Overdoses of Prescription Opioid Pain Relievers — United States, 1999–2008, Centers for Disease Control and Prevention Analysis: Morbidity and Mortality Weekly Report (MMWR), November 4, 2011 / 60(43);1487-1492.
Source Ivanhoe News