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SpringTMS, sTMS mini no longer available?

The maker of SpringTMS and sTMS mini, eNeura, filed for Chapter 7 bankruptcy on Friday, August 7. In Chapter 7 bankruptcy, companies liquidate their assets, so this doesn’t look good for short-term access to SpringTMS. I don’t know anything for certain, though—all the information I have is the bankruptcy filing and that eNeura’s customer service is not responding “due to unforeseen circumstances,” as the auto replies say. Despite this, their website is still active.

That’s unfortunately all I can say for certain right now. I have industry contacts keeping an eye out for the SpringTMS to become available to patients again, whether from eNeura or another company that purchases the technology.

I’m sorry to share such bad news. My heart hurts for everyone who relies n these devices for migraine management and wish I had more information for you. I’ll keep you posted if I learn anything new.

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gammaCore for Migraine Received FDA Approval!

The gammaCore is an external vagus nerve stimulator that can be used to treat migraine and cluster headache. It received FDA approval for cluster headache last summer and was approved for migraine today.

It’s also the new treatment I’ve been using since June 2016 and haven’t been able to tell you about it.

Here’s a bit more information:

I’m traveling for work right now and working on my phone is killing my neck, so that’s all I have for you today. Now that I can spill the beans, I’m super excited to share more and will as soon as I can.  I’ll also have a video up on Migraine.com soon and will link to it when it’s available.

 

 

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CGRP Drug for Chronic Migraine: Very Promising Study Results

cgrp-drug-for-chronic-migraineAmgen’s CGRP drug provided significant relief to participants with chronic migraine, according to new study results presented at an international conference in mid-September. The drug, called erenumab, was tested at two doses, 70 mg and 140 mg. “Both doses of erenumab were associated with significant improvements in health-related quality of life, headache impact, disability, and level of pain interference, compared to placebo,” according to Amgen’s press release announcing the study’s results.

Here’s a brief summary of the study’s details and it’s findings.

In the 12-week study, 667 participants were given monthly injections of either the drug, called erenumab, or a placebo. The breakdown was:

  • 191 participants received 70 mg erenumab
  • 190 participants received 140 mg erenumab
  • 286 were injected with the placebo

All participants had chronic migraine. At the start of the study, they had an average of 18 migraine days per month and 21.1 headache days each month. The following outcomes were assessed during the last four weeks of the study.

  • Reduction in migraine days per month: Those who were given erenumab (at either dose) had an average of 6.6 fewer migraine days a month.
  • 50% or greater reduction in the number of migraine days per month: 40% of participants who received the drug at 70 mg and 41% who got 140 mg had their number of headache days decreased by at least half.
  • Reduction in use of acute migraine drugs (abortives): Participants who received 70 mg of erenumab took abortives on 3.5 fewer days; those who received 140 mg reduced their medication use by 4.1 days.
  • Reduction in headache hours: Participants who received 70 mg of erenumab had 64.8 fewer headache hours in the month; those who received 140 mg of erenumab had 74.5 fewer headache hours.

Side effects

No adverse effect was reported in more than 5% of the participants. Those reported were:

  • Injection site pain: 3.7% in participants who received the active drug at either dose; 1.1% placebo
  • Upper respiratory tract infection: 2.6% at 70 mg; 3.7% at 140 mg; 1.4% placebo
  • Nausea: 2.1% 70 mg; 3.2% 140 mg; 2.5% placebo

This yet is another promising report on the CGRP drugs that are in development for migraine prevention. All studies so far have found a notable reduction in migraine frequency and improvement in health-related quality of life for a significant portion of participants. Minimal side effects have been reported thus far. This was a Phase 2 study. Phase 3 studies, which are underway now, will include more participants and give us more information on side effects.

(Amgen has also issued a press release about the first CGRP drug Phase 3 results I’ve seen. Participants in the study had between four and 14 migraine days a month. Those given erenumab had an average of 2.9 fewer migraine days per month. With such a wide range in migraine frequency, it’s hard to tell how impressive that number is. But even for someone with 14 migraine days a month, the average would mean about 20% fewer migraine days.)

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Migraine and Stroke, Heart Disease: Understanding the Risks

Learning that research has found connections between migraine and stroke and heart disease can be chilling. Fortunately, the news is not as bad as it might first appear. I spoke with headache specialist Gretchen Tietjen, M.D., about an article on the connection between migraine and an increased risk of stroke and cardiovascular disease that she wrote for the American Migraine Foundation. “From a patient’s perspective, this information is frightening,” I told her (because I have no poker face, even on the telephone). Dr. Tietjen soothed my worries tremendously by putting the information into perspective.

“It can be very scary when you read things like this,” Dr. Tietjen said. “Study after study shows this little bit of increase.” However, the risk is very small. The most important takeaway is that patients should keep migraine in mind as part of their overall risk for stroke and heart disease. If you have migraine and are at increased risk of stroke or heart disease, it’s extra important to be aware of and manage those risk factors.

Migraine Increases the Risk of Stroke and Cardiovascular Diesease (But Only a Little Bit)

Yes, migraine does increase the risk of stroke, particularly for women who have migraine with aura. But the risk is very, very small. Less than 1% of all strokes in women have any connection to migraine. And the presence of a connection is not proof of a causal relationship—that is, just because the two are linked doesn’t mean that migraine causes stroke.

The article reports that a recent study found “that migraine increases the risk of stroke, coronary events, and related death by about 50%.” At first glance, that sounds terrifying, but Dr. Tietjen’s clarification was soothing. She said, “This sounds worrisome but to put this in perspective only 1% of the total population in the study had a cardiovascular event over the 20 years of follow-up. The take home message is that having migraine does not mean you will have heart disease or a stroke, only that it appears to slightly increase the risk.”

Risk Factors For Stroke and Heart Disease

Dr. Tietjen highlighted risk factors like smoking, high blood pressure, high cholesterol, and diabetes. She said that in people with migraine, these factors have an additive effect—the combination of more than one risk factor is worse than any one by itself. If you have any of these risk factors in addition to migraine, quitting smoking, lowering your blood pressure and/or cholesterol, or getting your diabetes under control could lower your risk of heart disease substantially. Smoking is the risk factor that stands out the most to Dr. Tietjen. Studies of migraine and smoking have shown that the combination of the two increases your stroke and heart disease risk more than either one on it’s own.

Learn More About Migraine, Stroke and Heart Disease

Dr. Tietjen’s article, Migraine, Stroke and Heart Disease has in-depth information on who is at increased risk of stroke, differentiating between symptoms of migraine and stroke, the physiological links between migraine and stroke, and ways to lower your risk. As you read the article, keep in mind that the absolute risk is small and that you can modify your risk factors for stroke and heart disease. And make a list of any questions you may have so you can ask your doctor at your next appointment.

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Miles for Migraine Raises Awareness, Research Funding

Miles for Migraine logoThrough Headache on the Hill, patients and healthcare providers lobby members of Congress each year to increase NIH funding for research into headache disorders. The first year, participants were told that they would have to raise “big noise” in their own communities to see a change. This is something people who advocate for more research funding hear often: lawmakers must believe that the people they represent care about migraine and other headache disorders. That is, we won’t get research funding until we raise awareness about the impact these illnesses on people’s lives.

Miles for Migraine Raises Awareness, Research Funding

In 2008, Eileen Jones decided to make big noise by founding Miles for Migraine. After attending the first Headache on the Hill in 2007, Eileen, a nurse who has migraine, founded Miles for Migraine to raise both funds for and awareness about migraine. Since the first race in San Francisco, Miles for Migraine has raised $79,000 for migraine research and advocacy. Their goal is to fund 30+ fellowships to train new doctors to become headache specialists. Prior funding recipients include:

Race Locations

That $79,000 is just the start. Last year, the race expanded to Philadelphia; this year, a race has been added in Chicago. Depending on the city, races range from one-mile walks to a full marathon. If you’re unable to participate in or attend a race, you can still get involved through Miles for Migraine’s virtual race.

Virtual Race

When Miles for Migraine comes up, people inevitably say that exercise is a migraine trigger, they’re too sick to exercise, or migraine makes their lives so unpredictable that they’re unlikely to be able to attend an organized event. I get this—all have been true for me at different times in my migraine life—and the people at Miles for Migraine get it, too. That’s where the virtual race comes in. You can recruit others to run for you, collect donations for a run/walk you do on your own (a short trip on the treadmill counts!), or you can fundraise without running at all. All those options raise both awareness of migraine’s impact on people’s lives and money for research and advocacy. Donations of at least $100 will get you a T-shirt and race goody bag. See Miles for Migraine’s virtual race on Crowdrise for more information.

2016 Miles for Migraine Races

  • San Francisco on Sunday, July 31: San Francisco Marathon (Mission Street & The Embarcadero); 5K Walk/Run, Half Marathon, Full Marathon
  • Chicago on Monday, September 5 (Labor Day): Naperville Last Fling (440 W. Aurora Avenue, Naperville, IL 60540); 1 Mile Run, 5K Run
  • Philadelphia on Saturday, October 8: Valley Green/Fairmount Park (120 W. North Western Avenue, Philadelphia, PA 19118); 2 Mile Walk, 5K Run, 10k Run