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New drug shows promise as migraine headache preventive

Reporters and editors get dozens of emails and story pitches every day. But one recent news release from the American Academy of Neurology caught my attention immediately.

It was about a clinical trial involving a new drug for preventing migraine headaches. Even better, it's part of a new class of drugs specifically developed to prevent migraines. All the preventive medications currently available were first used to treat other health conditions.

In the new trial, patients reported fewer headache days each month, with almost no major side effects.

It was the best news to come along in years. Suddenly I was hopeful about getting relief from a painful condition that has dogged me for more than three decades.

My migraines started when I was in elementary school in Virginia. I used to call them a headache in my eye. Maybe that's why my parents kept taking me to opticians and buying me eyeglasses with sparkly pink frames and stars and poodles on the sides — they thought the headaches were caused by eye strain.

The glasses didn't help. But because the headaches were isolated and occurred just a few times a year, we didn't give them much thought. I don't remember taking so much as an aspirin for the pain or being taken to the doctor because of them.

It wasn't until I landed a new job and moved to Florida in 1985 that the headaches became much more frequent and debilitating. It took a while for me to eventually connect with a neurologist who told me I had migraines. By this time, I rarely woke without a headache.

I also noticed they could be triggered by hunger, alcohol, caffeine, citrus or changes in my sleep schedule.

My mistake was trying to manage the problem myself and not seeking treatment with a specialist sooner. I thought I just had headaches more often than other people — that the only thing to do was to take Tylenol. And when that didn't work, to just take more.

Eventually, I learned that taking too much pain medication made the pills less effective and caused even more headaches, known as rebound headaches. And, I learned that most people who have frequent migraines need to be on a daily preventive medication to reduce the need for pain relievers.

A daily preventive isn't something you take after a headache hits. It's taken every day, even on days without headaches, to prevent the attacks, lessen their number and to reduce the pain intensity of those that do break through.

According to the National Headache Foundation, migraines affect more than 30 million Americans, more women than men. About 3 million suffer chronic migraines — meaning a headache 15 or more days each month for three months or more, with eight of them being migranic in nature, lasting four or more hours.

As a chronic migraine headache sufferer, you're also most likely missing a lot of work or school or social activities, and are unable to perform some activities of daily living like grocery shopping, housekeeping, working out or shuttling children around.

"Preventives increase the number of days that you can work, socialize, participate in life," said Dr. Teshamae Monteith, a headache neurologist and chief of the headache division in the department of neurology at the University of Miami Miller School of Medicine. "Preventives can reduce the frequency and severity of attacks, make treatments, even over-the-counter ones, work better and generally make migraines easier to treat."

The most common preventives were originally intended to treat such health problems as high blood pressure, depression, epilepsy, even aging. They often come with bothersome, sometimes intolerable, side effects, including dry mouth, drowsiness, weight gain, constipation, mind fog, difficulty speaking or swallowing, changes in taste, tremors, nightmares and hallucinations.

I've had to abandon several preventives because of side effects. Others worked for a while and then, after a few years, stopped working.

Some patients find relief from a common cosmetic procedure.

"I have a lot of success treating patients with Botox. It's helpful for a good percentage of people," said Dr. Robert Vollbracht, a headache neurologist at Clinical Neurosciences of Tampa Bay based at Morton Plant Hospital in Clearwater.

Botox is best known for smoothing wrinkles and relaxing the "parenthesis" frown lines between the eyebrows. To treat chronic migraines, patients receive 31 injections of botulinum toxin around the head and neck. The injections are given every 12 weeks; it can take two or three rounds of treatment to get results.

Some patients find the shots painful but report getting relief for several months at a time. (Vollbracht says diluting the medication slightly can make the injections less painful.)

Doctors aren't sure why Botox works, but they think it does more than just relax the head and neck muscles. It may play a role in preventing the body from sending out pain signals during headaches. Still, it is the only FDA-approved drug for prevention of chronic migraines.

"I find that preventives work about 50 percent of the time. So it can take a lot of trial and error to find one that works for you," Vollbracht said. "It may take a combination of medications to get results." Or sometimes the dose just needs to be adjusted.

Patients need to understand, he added, that what doesn't work for you may work for someone else. You also have to give the medications time. It can take weeks or months to get relief.

The new medication that got my attention doesn't even have a name yet. It's known as TEV-48125 and is a monoclonal antibody, part of a new class of drugs that target and block a chemical in the brain called CGRP that increases during migraine headaches. TEV-48125 is manufactured by Teva Pharmaceuticals, and three similar drugs are currently in development.

In a study released earlier this month by Teva, some patients with chronic migraines reported relief within days of the first treatment. After a week, people on a low dose of the drug had an average of nine fewer hours of head pain, and those on a higher dose had 11 fewer headache hours. In the trial, reported in the journal Neurology, the drug was injected once a month for three months.

"This one from Teva is quite exciting," said Dr. Janice Maldonado, an assistant professor of neurology at USF Health based at the Neurology, Pain and Headache Clinic at Tampa General Hospital. She is not involved in the clinical trial.

"This takes into consideration the physiology of migraine," Maldonado said. "It's a carefully thought out approach to treatment that attacks the generator of the migraine itself. It should work."

Monteith, the Miami neurologist, is part of a clinical trial testing a similar monoclonal antibody manufactured by Eli Lilly and Co. for the treatment of cluster headaches. She thinks TEV-48125 looks promising too.

"It treats the root cause of migraines," she said. "It may also be safe for people with cardiovascular disease, but further study is needed to confirm that. That might be a bonus."

One of the key classes of drugs for stopping a migraine after it starts, the triptans, (Sumatriptan or Imitrex, Eletriptan or Relpax and Zolmitriptan or Zomig) can't be given to people with certain heart conditions or a heart attack or stroke history because of the effect they have on blood vessels.

The clinical trials continue, but doctors are hopeful the FDA could approve the first CGRP blocker by 2018.

What will it cost? It's hard to say, but some experts estimate the drug will run between $8,000 and $20,000 a year. Some monoclonal antibodies currently used to treat cancer, for example, cost as much as $50,000 annually. Getting insurance companies to cover such expensive drugs may be difficult and will take time. Copays could be high.

Scientists also need to know what the long-term health effects of using a CGRP blocker are and how the drug will perform when given to thousands of patients in large nationwide trials, instead of a few hundred patients at a handful of study sites.

Still, I can't help but be quietly excited. And, hopeful for the first time in years.

Times researcher John Martin contributed to this report. Contact Irene Maher at [email protected]

Migraine symptoms

Migraines are distinguished from other headaches by a few characteristics, including:

• Moderate-to-severe head pain, usually but not always on one side, and often over one eye

• Nausea or vomiting

• Light or sound sensitivity

• Sweating, chills, diarrhea, overall ill feeling

• Visual disturbances such as sparkling or flashing lights, blind spots, zigzag lines in vision

Some people experience food cravings, depression, irritability, drowsiness, difficulty speaking, confusion or an inability to concentrate.

Because migraine pain can radiate to the nose, face, neck and shoulders, people are often misdiagnosed with sinus headaches or tension headaches when they actually have migraines.

Prevention tips

Avoid triggers. These are some of the most common things that may bring on a migraine attack:

• Bright or flickering light

• Loud noises or noisy rooms

• Strong smells, including certain foods, tobacco smoke, perfume

• Exercise (see note)

• Skipping meals, hunger

• Alcohol

• Caffeine

• Poor sleep or changes in sleep schedule

• Hormonal changes

What can help

• Yoga

• Stress reduction

• Exercise (see note)

• Supplements, including magnesium, vitamin B-12, Coenzyme Q10, Butterbur

• Oxygen therapy

• Acupuncture

• Chiropractic care

• Treatment for TMJ (jaw joint disorder)

Note: Exercise can trigger migraines, or help ease them, depending on the person.

Alert: It may not be a migraine

• A sudden, severe headache — especially when accompanied by sudden difficulty talking, trouble understanding speech, weakness (may be one-sided), difficulty walking, problems with balance or facial drooping — may be a sign of stroke, and you should call 911 immediately.

• If you have a stiff neck with a severe headache, get to a hospital immediately. It may be meningitis.

Helping out

To find out about participating in the TEV-48125 trial, call Teva U.S. Medical Information at toll-free 1-800-896-5855. There are study sites in Orlando and Ocala. You can also search for clinical trials at

Irene Maher, Times staff writer

New drug shows promise as migraine headache preventive 06/23/16 [Last modified: Thursday, June 23, 2016 5:54pm]
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