Botox for Migraine: Sept., 2010, Update

Botox100 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,


 

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© Teri Robert, 2010
Last updated September 13, 2010


New Migraine and Headache Clinical Trials

Cady100 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,


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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

 

 

Page copy protected against web site content infringement by Copyscape

© Teri Robert, 2010
Last updated August 16, 2010


The Basics of Clinical Trials

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.


Clinical Trial Opportunities

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.