All of us who struggle with Migraine disease know that there's an enormous need for more research into Migraine. Yes, we need more research to find new and better treatments, but there are other types of research we need also. We need more research into the epidemiology and pathophysiology of Migraine, and we need research to answer specific questions about treating Migraine.

The good news is that there's a trial currently enrolling to answer one of the specific questions about treating Migraine. The trial is the Medication Overuse Treatment Strategy (MOTS) Trial. It's designed to answer questions that are very important to people with chronic Migraine. One of the biggest challenges to all of us with chronic Migraine is that using acute medications more than two or three days a week can very easily lead us to another problem, medication overuse headache (MOH).

Before I tell you more about this important study, let's discuss MOH a bit. First, I realize that the name "medication overuse headache" is a problem for some people. Let me assure you that it's just a name. Nobody associated with the study is passing judgement or blaming anyone who finds themselves in an MOH situation.

For anyone who isn't familiar with what MOH is or what can cause it, here's more info. The International Headache Society has set diagnostic and classification criteria for MOH that are quite complete in listing which medications can cause MOH in their International Classification of Headache Disorders, 3rd edition (ICHD-3). For a diagnosis of medication overuse headache, a pateint must experience at least 15 days of headache per month, and meet this criteria:

8.2 Medication-overuse headache (MOH)

8.2.1 Ergotamine-overuse headache Overuse defined as ergotamine intake on 10 or more days/month on a regular basis for more than 3 months.

8.2.2 Triptan-overuse headache
Overuse defined as triptan intake (any formulation) on 10 or more days/month on a regular basis for more than 3 months.

8.2.3 Analgesic-overuse headache
Overuse defined as intake of simple analgesics on 15 or more days/month on a regular basis for more than 3 months.

• 8.2.3.1 Paracetamol (acetaminophen)-overuse headache Regular intake of paracetamol on 15 days per month for more than 3 months.
• 8.2.3.2 Acetylsalicylic acid-overuse headache Regular intake of acetylsalicylic acid on 15 days per month for more than 3 months.
• 8.2.3.3 Other non-steroidal anti-inflammatory drug (NSAID)-overuse headache
  Regular intake of one or more NSAIDs other than acetylsalicylic acid on 15 days per month for more than 3 months.

8.2.4 Opioid-overuse headache Overuse defined as intake of opioids on 10 or more days/month on a regular basis for more than 3 months.** Comment:** Studies show that patients overusing opioids have the highest relapse rate after withdrawal treatment.

8.2.5 Combination analgesic-overuse headache Overuse defined as intake of simple analgesic medications on 10 or more days/month on a regular basis for more than 3 months.** Note:** The term combination-analgesic is used specifically for formulations combining drugs of two or more classes, each with analgesic effect or acting as adjuvants.

8.2.6 Medication-overuse headache attributed to multiple drug classes not individually overused
Regular intake of any combination of ergotamine, triptans, simple analgesics, NSAIDs and/or opioids on a total of 10 days per month for more than 3 months without overuse of any single drug or drug class alone.

As you can see, any acute medication (medication used to treat a Migraine or headache when it occurs) can, if overused, cause MOH. Even alternating the types of acute medications leaves us vulnerable to MOH (see 8.2.6 above). 

More about the study:

This video by Dr. David Dodick, one of the primary investigators of the MOTS trial is a good introduction to the study:

The aim of this study is to compare two real-world strategies for treating patients who have chronic migraine with medication overuse, each with evidence for effectiveness:

• Transition from the overused acute medication used during migraine attacks to different acute medication (prescribed with parameters to avoid medication overuse) with optimized preventive treatment;
• Optimized preventive treatment without transition from the overused acute medication.

Although both of these treatment strategies are commonly used, there's insufficient evidence to know if one of these methods is superior to the other or if they provide similar outcomes. 

Patients participating in the study will be randomly assigned to one of two treatment arms matching the two strategies. It's very important to understand that patients who are randomized into the transition arm, will NOT be left without acute treatments. The treatments causing medication overuse will be discontinued, BUT other treatments will be prescribed to take their place.

There are no experimental treatments being used in this study. Participants must be patients at one of the study locations or become patients at one of them so they get consistent treatment from their own physician during the study. Centers participating in the study include Migraine and headache centers, general neurology practices, and family medicine practices. Centers participating in this study include:

Arizona

• Northern Arizona Healthcare Medical Group; Flagstaff, Arizona
• Mayo Clinic in Arizona Headache Center; Phoenix, Arizona
• Mayo Clinic in Arizona Neurology Center; Phoenix, Arizona
• Pinnacle Internal Medicine and Headache Center; Phoenix, Arizona
• Mayo Clinic Thunderbird; Scottsdale, Arizona

California

• Orange County Migraine and Headache Center; Irvine, California
• Cedars-Sinai Medical Center; Los Angeles, California

Colorado

• University of Colorado Denver Colorado Headache Center; Aurora, Colorado
• University of Colorado Denver Primary Center; Denver, Colorado

Florida

• Mayo Clinic Florida Headache Center; Jacksonville, Florida

Massachusetts

• Brigham Women's Hospital Headache Clinic; Boston, Massachusetts
• Brigham Women's Hospital Neurology Clinic; Boston, Massachusetts

Minnesota

• Mayo Clinic Headache Center; Rochester, Minnesota

New York

• DENT Neurologic Institute Amherst, New York

Ohio

• University of Cincinnati Neurology; Cincinnati, Ohio
• University of Cincinnati Primary; Cincinnati, Ohio
• University of Cincinnati Headache Center; Dayton, Ohio
• Toledo Clinic General Neurology; Toledo, Ohio

Pennsylvania

• Thomas Jefferson University Hospital Headache Center; Philadelphia, Pennsylvania
• Preferred Headache Center; Pittsburgh, Pennsylvania

Utah

• University of Utah Primary Care; Salt Lake City, Utah
• University of Utah General Neurology; Salt Lake City, Utah
• University of Utah Headache Center; Salt Lake City, Utah

Wisconsin

• Medical College of Wisconsin; Milwaukee, Wisconsin

The primary investigators for the MOTS trial are Dr. Todd Schwedt and Dr. David Dodick, both at the Mayo Clinic Headache Center in Arizona. I'm honored to be their co-investigator for this trial, my first venture into research. The study is funded by the Patient Centered Outcomes Research Institute (PCORI).

If you have chronic Migraine and medication overuse, I hope you'll consider being part of this important study. It's an opportunity to address your Migraine treatment AND to help answer this important question that so many of us face.

For more information:

• Visit the MOTS Trial web site.
• Check out the MOTS Trial Facebook page.
• Follow @MOTSTrial on Twitter.
• Click the "Email Me" button to the right or at the bottom of this page, depending on how you're viewing this post, to send me an email.

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Clinical trials to determine the efficacy of Botox (botulinum toxin type A) for Migraine prevention have been underway for several years. During this time, some doctors have used Botox off-label for their patients. Let's take a look at where things stand now, in September of 2010.

A bit of background: Off-label prescribing or usage of medications is very common. "Off-label" simply means using a medication for a purpose other than those for which the FDA has specifically approved it. Once a medication is approved by the FDA for human use, it's both legal and legitimate for doctors to prescribe it for other conditions when they believe it will be helpful. Migraine preventive medications are a perfect example of off-label prescribing. Of the more than 100 medications in use today, none of them were originally developed for MIgraine treatment. They were all developed for other conditions, then found to work as preventives for some Migraineurs. Four of them were put through the additional clinical trials to win formal FDA approval for Migraine prevention:

1. propranolol, a beta blocker, brand name Inderal
2. timolol, a beta blocker, brand name Blocadren
3. divalproex sodium, a neuronal stabilizing agent (anticonvulsant), brand name Depakote
4. topiramate, a neuronal stabilizing agent (anticonvulsant), brand name Topamax

What's NOT permitted:

It's legal to prescribe medications off-label, BUT it's not legal for pharmaceutical companies to promote or advertise a medication for any purpose for which it's not FDA approved. That means that Allergan, the manufacturer of Botox, may promote and advertise it for the purposes for which it is already approved - cosmetic purposes, blepharospasm, cervical dystonia, hyperhidrosis, strabismus, and upper limb spasticity. Promoting it for off-label use constitutes what the FDA calls "misbranding," and it's illegal.

Recently, Allergan was in the news when they agreed to pleas guilty and pay a $600 million fine to resolve allegations that they had promoted Botox off-label.

A point that needs to be understood about this is that the issue was NOT about doctors using Botox off=label. It was entirely about allegations that Allergan had promoted it for purposes other than those for which it was FDA approved. So, it has nothing to do with the medication itself, but about marketing and promotion practices.

Good news of progress:

Botox was recently approved in the UK for treating Migraine. In the U.S., the FDA is currently reviewing clinical trial data about Botox and Allergan's application for FDA approval of Botox for Migraine treatment. Many Migraineurs are hopeful that FDA approval will come soon. I've heard from many Migraineurs who would like to have the option for trying Botox for MIgraine prevention, but their insurance companies decline payment, saying that the treatment is "experimental" or "investigational."

If you've been wondering about Botox, you might be interested in reading Allergan's information about Botox History and Development, which includes a time line of when Botox was approved for various uses.

Live well,

Get the latest Migraine and headache news, informational articles, tips for living well, and more in my free weekly newsletter. To subscribe, CLICK HERE.

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© Teri Robert, 2010
Last updated September 13, 2010

Dr. Roger Cady and his research group have let me know that they have some new Migraine and headache clinical trials that are recruiting participants.

If you live near Springfield, Missouri, you may be interested in some of these trials:

Evaluating the Effectiveness of Early Acute Treatment vs. Preventive Treatment for Migraine

Did you know that 60-80% of migraine sufferers experience signs before a migraine attack that may actually predict the onset of a headache? These signs are referred to as prodrome and may include symptoms such as muscle aches, food cravings, mood changes, decreased or increased energy, difficulties with memory or concentration and even excessive yawning.

If you:

• Are age 18 or older
• Experience prodrome symptoms as described above
• Have never taken Frova® or Topamax® for migraine treatment or prevention
• Live near Springfield, Missouri
  

Please consider enrolling in this medical research study. Qualified candidates will receive study related medical evaluations and study medication at no charge plus compensation for time and travel. For more information, please contact call 417-883-7889.

• • • • •

Have you had a mild head injury that has left you with chronic headaches?

Clinvest is conducting a medical research study testing an approved migraine drug to see if it safely and effectively relieves post traumatic headaches.

If you:

• Are between the ages of 18 and 65
• Have had a problem with headaches since the injury
• Have trouble with concentration and memory due to the headaches
• Live Near Springfield, Missouri

Please consider volunteering for this medical research study. No insurance is necessary because if you qualify and choose to participate you will receive all study related medical evaluations and study drug at no charge. Compensation for time and travel is also provided. For more information, please contact 883-7889.

• • • • •

Help Us Learn More About the Effects of Migraine On Work Productivity

Workers who experience migraines suffer approximately a 50% decrease in work productivity. Help us learn more about how 2 different treatments affect the way you function at work by volunteering for this medical research study.

Please consider participating if you:

• Are age 18-65
• Work at least 30 hours each week
• Are able to complete 1-2 minute hourly assessments from your cell phone when treating 4 headaches at work
• Routinely treat your headaches with a Triptan or Treximet®
• Live Near Springfield, Missouri

Study participants will receive compensation for time and travel. For more information, please contact Clinvest at 417-883-7889.

• • • • •

Do You Suffer from Chronic Headaches?

Clinvest is currently recruiting volunteers to participate in a medical research study to see if an investigational drug reduces the number and severity of chronic headaches.

If you:

• Are age 18-65
• Experience a headache on 15 or more days each month
• Are willing to help find a way to manage chronic headaches
• Live near Springfield, Missouri.

Please consider enrolling in this medical research study. Qualified candidates will receive study related medical evaluations and investigational drug at no charge. Compensation for time and travel is also provided. For more information, please contact Clinvest at 417-883-7889.

• • • • •

New Class of Investigational Migraine Drug Being Tested for Menstrual Headaches

That time of the month can be challenging enough without having to endure a
headache, too.

If you:

• Are age 18 or older.
• Have experienced a headache during at least 1 of your last 3 monthly cycles.
• Live near Springfield, Missouri.

Please consider volunteering for this medical research study. If you qualify and choose to participate you will receive:

• All study related medical evaluations and investigational drug or placebo (inactive substance) at no charge.
• Compensation for time and travel.

For more information please contact 417-883-7889.

Live well,

Get the latest Migraine and headache news, informational articles, tips for living well, and more in my free weekly newsletter. To subscribe, CLICK HERE.

Follow me on or

© Teri Robert, 2010
Last updated August 16, 2010

We often hear about new treatments literally years before they're available to us because they're reported on when still in clinical trials. What are clinical trials? How do they work? With the answers to these questions, you can learn more about them and determin if you may be interested in participating.

Choosing to participate in a clinical trial is an important personal decision. These frequently asked questions provide detailed information about clinical trials. In addition, it is often helpful to talk to a physician, family members, or friends about deciding to join a trial. After identifying some trial options, the next step is to contact the study research staff and ask questions about specific trials. Feature article.

Dr. John Claude Krusz has openings in new clinical trials beginning soon at his clinic, the Anodyne Headache and PainCare Center, in Dallas. Participants within a 50- to 75-mile radius of Dallas are needed for the following trials:

• Adolescent Migraine Headache Study- adolescents between ages 12-17 years old with at least one year of migraine headaches. It is a daily medication and adolescents will be required to keep a headache diary. This is a year long study.
• Aricept for mild cognitive difficulties after traumatic brain injury. There must be documentation of traumatic brain injury. This is a 12 week study. Ages 18-65.
• Frova for perimenstrual migraines. 4 month study. Ages 18-45.
• Investigational medication for post herpatic neuralgia. This is a 10 week study to investigate the treatment of pain after shingles. Ages 18 and over.
• Botox for Migraine. Patients must be between 18-65 with at least 15 Migraine days a month. This is a year long study.
• Niravam for anxiety or panic disorder. This is a 8 week study. Ages 18-65.

For more information, contact Stephanie Hall at 214-750-4727.