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Promising Migraine Preventive Drugs Target CGRP

Positive findings from two phase II clinical trials of promising migraine preventive medications were announced today (here’s the full press release). If these drugs make it to market, they’ll be the first developed specifically for migraine prevention.

These drugs are the first to test monoclonal antibodies for migraine prevention and both target the protein calcitonin gene-related peptide (CGRP). If those words are gibberish to you, here’s a brief introduction to CGRP and its role in migraine from James at Headache and Migraine News. (I intend to write an explanation at some point, but don’t currently have the mental ability.)

The first study included 163 people who had five to 14 days of migraine attacks each month. They either received a single IV dose of the drug, called ALD403, or a placebo*. After 24 weeks, those who received the drug had an average of 5.6 fewer migraine days a month (a 66% reduction) than before receiving the dose and 16% were migraine-free after 12 weeks. Those who received the placebo had 4.6 fewer days per month (a 52% decrease) and none were migraine-free. Side effects were the same for both groups.

The second study included 217 people who had migraine from four to 14 days per month. For 12 weeks, participants received biweekly injections of the drug, LY2951742, or a placebo. After 12 weeks, those who received the drug had an average of 4.2 fewer migraine days a month (a 63% decrease), while those who received the placebo had 3 fewer migraine days a month (a 42% reduction). Participants who received the drug were more likely to have side effects than those who received the placebo. These side effects included pain at the injection site, upper respiratory tract infections and abdominal pain. Still, the drug was considered overall to be safe and well-tolerated.

Those are definitely good early results. More, larger studies are needed to confirm the findings.

Even more than the results, I’m struck by the positive, hopeful comments from two researchers involved in the studies, both highly regarded in the field:

“These results may potentially represent a new era in preventive therapy for migraine.” –Peter Goadsby, MD, PhD, UC San Francisco

“We’re cautiously optimistic that a new era of mechanism-based migraine prevention is beginning.” –David Dodick, MD, Mayo Clinic Arizona

While not effusive, these comments echo the optimistic, hopeful attitude I’ve heard countless headache specialists use when talking about CGRP drugs. I, too, am quite hopeful for these drugs.

*The placebo effect is way oversimplified as the power of positive thinking. The process is far more intricate that “you think it will work, so it does.” It’s another topic I’m planning a post on, but I don’t know when I’ll get to it. If you’re curious to learn more, Jerome Groopman’s book The Anatomy of Hope describes it well, and Placebo Effect Stronger Than We Thought? is a good article.

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Clinical Trials for Treating All Sorts of Headache Disorders

ClinicalTrials.gov is the place to go if you’ve considered participating in a clinical trial for your headache disorder, These are just the latest in 142 headache studies recruiting participants or will be recruiting soon.

Nearly every headache disorder is represented: cluster, tension-type, post-traumatic, migraine, cervicogenic, lumbar-puncture, medication overuse (rebound)…. Treatments range from medication and surgery to diet, coping skills training, relaxation, meditation, yoga, exercise… Again the list goes on.

The diverse collection of current studies include:

Even if you’re not interested in any of these studies, checking the government’s clinical database regularly may turn up something new that works for you. Searching for “headache” gets the most results, but you can also search by specific headache type. For example, there are 74 active studies on migraine and seven on cluster headaches.

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Vipassana Meditation for Chronic Daily Headache (Migraine): Clinical Trial Recruiting Participants

Meditation is highly regarded yet little-studied for managing chronic daily headache and migraine. Intensive Meditation and Migraines: Effects on Health and Well Being is a clinical trial of Vipassana meditation and chronic daily headache (the migraine sort). The year-long study includes a 12-day retreat to learn the technique. Researchers describe the study as:

Participants completing training in intensive meditation and continuing frequent practice for one year would experience reduced frequency, duration and severity of headaches along with improved awareness of the triggers of their symptoms, improved quality of life and mental health, improved heart rate variability, and reduced inflammation.

For more information on the study, see the recruiting page on ClinicalTrials.gov. Learn more about Vipassana meditation from Wikipedia’s excellent external links list.

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What Are Clinical Trials All About?

WebMD recently published lots of information on clinical trials. There’s more here than one person can possibly retain, so take small bites!

Is a Clinical Trial Right For You?
Clinical trials are experiments. As such, they may involve risks, often serious ones. You have no guarantee how the trial will turn out if you choose to enroll. You also may undergo discomfort, inconvenience, and expense that you would not have had otherwise. Only you can decide whether joining a clinical trial is worthwhile or not, based on how you value the possible benefits and risks.

What to Expect in a Clinical Trial
Every clinical trial is a bit different so there is no typical trial.
Still, you may want to see an example of what a clinical trial really involves before joining. Here, we’ve created a fictional clinical trial designed to last one year. The description below resembles the “procedures section” you would find in the trial’s informed consent document.

Clinical Trials: Benefits and Risks
People participate in a clinical trial for many reasons. Healthy people may join clinical trials to contribute to medical science and improve medical knowledge and care for others. If you have a specific illness, clinical trials offer access to new approaches that are often not available otherwise. You should understand that clinical trials are still experiments. They
involve risks. Here are some of the risks the NIH urges you to consider before joining a clinical trial.

Clinical Trials: Your Rights and Informed Consent
Informed consent is a crucial aspect of clinical trials. Informed consent is the process of giving you all of the information that you need to make an informed decision about a research experiment.

Clinical Trials: 10 Questions to Ask
Before joining a clinical trial, you should feel comfortable and fully informed. The National Library of Medicine suggests a series of questions to ask before you enroll in a clinical trial, which we’ve adapted below. You should know the answers to all of these questions before you enroll.

Concerns for Women, Children and Genetic Privacy in Clinical Trials
The focus of clinical trials has changed in recent years. For decades, researchers mostly enrolled adult men and older women in clinical trials, but the number of studies devoted to children has grown enormously since 1997. Clinical trials that include genetic tests have also become increasingly common. These new developments have changed who enters clinical trials and the potential risks you may experience if you choose to enroll.

12 Answers to Common Questions About Clinical Trials

Glossary of Terms Used in Clinical Trials

If you’ve participated in a trial, I’d love to know what you thought and how it went. Please leave a comment or e-mail me.

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Current Clinical Trials for Headache, Migraine & Cluster Headache

NIH’s clinical trials database is brimming with clinical trials for headache disorders. There are currently 110 headache, 65 migraine and five cluster headache studies either actively recruiting or will do so soon.

Topics include:

And there are many, many more. Many are for drugs, but others have minimal risks.You can search by which phase trails are in, I, II and III. The website breaks down how the trials differ:

  • In Phase I clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
  • In Phase II clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
  • In Phase III studies, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

To learn more about clinical trials and for definitions, stay tuned for tomorrow’s post.