News & Research, Society

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
News & Research, Treatment

Getting into a CGRP Drug Study for Migraine

Getting into a CGRP drug study for migraineThe logistics of finding a CGRP drug study are relatively simple—the hard parts are meeting the study criteria and living close enough (or being able to travel) to a location that needs trial participants.

Finding Clinical Trials

ClinicalTrials.gov is a registry of medical studies around the world. You can search for studies on any condition you’re curious about and can narrow the list by location. It’s the most detailed search, but can be overwhelming.

CenterWatch is another database of clinical trials. You can search studies and research centers by condition and/or geographic location. It has less information than ClinicalTrial.gov, but the format is easier to follow. CenterWatch offers a free email notification service of new trials.

The Center for Information and Study on Clinical Research Participation will search trials for you. Call 1-877-MED HERO or complete the online search request form to receive search results by email in about a week. (The trial search function on the website searches CenterWatch’s database.)

Current CGRP Drug Studies for Migraine

My search for migraine CGRP on ClinicalTrials.gov turned up 29 studies, many of which have already been completed. The ones that are currently recruiting are:

Don’t take this list as the only options—doing your own search with your own terms might turn up something I missed. You can save time by limiting results to the state you live in. New studies are added all the time, so be sure to check back for ones that you might qualify for. Or sign up for CenterWatch’s email alerts.

Study Eligibility

To really know how a drug or treatment works, researchers need to compare similar patients to each other. To do this, they must limit participants by certain eligibility criteria, which vary from one study to the next. Read through a study’s eligibility requirements closely—you may meet all the criteria except one (that’s usually the case for me). Frequency of migraine attack is a major criterion; how many preventives you have tried, drug allergies, recency of Botox injections, or having an uncommon subtype of migraine are some examples of other criteria.

Study Contacts

Depending on the study and where you’re searching, the contact may be a specific doctor or hospital, company that runs clinical trials, or a general contact phone number or email address. If you see the name of the center, but no phone number, Google the name and go from there. I’ve never had a central contact respond to email or phone calls, so I recommend trying every other possible avenue as well.

Talk to your doctor, too. They may know about trials in the area or have information on upcoming studies. This is most likely if you see a headache specialist at an academic headache center, but it’s worth a try even if you don’t.

What You Need to Know About Clinical Trials

Having the option of clinical trials is great for patients who need relief and want to try a new treatment, but they are still experiments. You may get a placebo. You may get the active drug, but at a lower dose than is effective. You may experience side effects that are not yet known. These risks are worth it to some people and not acceptable to others. If you are chosen for a study, ask every question you have and don’t agree to participate unless you are satisfied with the answers. Try to view the risks as objectively as possible to make the most informed decision you can. People can die during drug trials—that’s exceedingly rare and the CGRP drugs have had mild side effects in studies so far—but it’s important to try to keep your eyes wide open. It’s so easy to be blinded by a desire for relief (I speak from experience).

Learn More About Clinical Trials

If you’ve participated in in drug studies and would like to share your experience, please leave a comment or email me at kerrie[at]thedailyheadache[dot]com.

News & Research

Migraine Prevention With CGRP Drugs: Cost, Safety

migraine-prevention-cgrpYou’ve probably heard that monoclonal antibodies that inhibit CGRP are the exciting treatment in development for migraine prevention, but details have been scarce. New Migraine Drugs Promise Relief—But at a Steep Price is a different look at the drugs than has been published thus far. I’ve hit some highlights below and added my own thoughts, too.

Migraine Prevention is Costly & Access is Restricted

  • Monoclonal antibodies are made from living cells and are expensive to produce. They are among the most expensive drugs on the market right now.
  • Experts the writer interviewed gave cost estimates of between $8,000 and $20,000 per year. The CEO of Alder BioPharmaceuticals, which is one company working to develop these drugs, compared them to antibodies used to lower cholesterol. Those cost $14,000 a year when they came out. “I suspect we might be in that ballpark,” said Alder’s CEO.
  • Insurance companies tend to restrict drugs with hefty price tags. Think about the hoops people have to jump through for Botox, which costs insurance companies $6,000 to $10,000 per year.
  • Like with Botox, many insurance companies will likely require patients to fail trials of other medications before approving them for these new drugs. It’s likely that Botox will be one of those drugs that patients have to fail.

My Thoughts on Cost

  • How many insurance policies will simply exclude these drugs? Writing this post prompted me to see what Botox costs with my current insurance coverage (which I’m quite happy with). I assumed I would have to pay 30% of the cost. Nope, Botox is not covered at all. Even if it my doctor says I need it and even if it’s the only drug in the world available for my condition, my insurance will not cover Botox. Will they really cover an even more expensive drug?
  • Although studies are looking at both episodic and chronic migraine, I wonder how difficult it will be to get insurance companies to cover the drugs for people with episodic migraine. Drug coverage restrictions often center around quantity, but what are the rules are for a drug where quantity is always the same? If a drug has FDA approval for episodic migraine, can insurance companies require that a person have a minimum number of migraine attacks per month before they’ll cover it? If so, will this ultimately mean only people with chronic migraine get the drug?
  • On the bright side, these new drugs are likely to bring down the cost of Botox.

 

Drug Safety is Still in Question

  • These drugs are in Phase 2 trials. Half of drugs fail in Phase 3 studies or do not receive FDA approval.
  • When Phase 3 trials test the drugs on thousands more patients, dangerous side effects could be discovered.
  • We don’t know what the long-term effects of inhibiting CGRP will be.
  • CGRP is distributed throughout the body and is involved in many process, including regulating blood flow and wound-healing.

My Thoughts on Safety

  • Thus far, studies have shown a low side effect risk for these drugs. This is encouraging, but studies have had limited numbers of participants. More people using the drugs—both in late-stage trials and, if approved, in widespread use—will be required before we can really know what the side effects will be.
  • The very novelty that makes these drugs exciting also makes them scary—CGRP hasn’t been inhibited before. What will the long-term effects of the drugs be? How will they impact other physiological processes? What will research find after the drugs have been in use five years? fifteen? thirty?
  • I probably wouldn’t be thinking much about the long-term safety if it weren’t for recent studies linking anticholinergic drugs to dementia and cognitive impairment. Anticholinergics have been used widely for at least 70 years, but the first of these studies (that I can find) was published just 11 years ago. How many people were negatively affected by these drugs before the link was found?

I’m still excited about the potential of the drugs, but my concerns weigh heavily. Maybe these worries will shake out by the time the drugs are available in a few years. Right now, I don’t see myself clamoring to try them as soon as they’re available… although if my migraine attacks are back to being severe by then, I’ll probably camping out to secure my place toward the front of the line.

News & Research

Would you donate your brain to research?

I imagine that migraine has worn grooves into my brain, creating a map that will help researchers explore the wilderness of migraine. Although I know the changes are not so literal and visible, I’ve talked about donating my brain to migraine research for at least a decade. I want the agony I have endured to be used to further the understanding of migraine. I know my work does that to some extent; I want to do more. I want to impact the science. The American Registry for Migraine Research, which is getting up and running this year, will provide a place to do that. (Not only by donating brain tissue, but donating blood and saliva samples as well as data.)

I was interested in donating my body to science since well before chronic migraine disabled me. Then I started to read Stiff: The Curious Lives of Cadavers. It was so disturbing that I didn’t get beyond learning that cadavers are used for all sorts of science, including cosmetic surgery and crash testing cars. To me, donating my body to science is a way to advance medical knowledge. Having someone practice a nose job or tummy tuck on my dead body is less idealistic. I know those procedures are not always for cosmetic reasons, but the vast majority are.

I remain undecided about donating my entire body to research. Fortunately, this is not a decision I have to make. Not only because I don’t plan to die soon, but because the migraine registry will allow me to donate brain tissue to migraine research without committing the rest of my body to science.

Would you donate your brain to research?