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Clinical Trials Galore

After months of fruitless searches for headache or migraine related on NIH‘s clinical trials database, there’s a plethora of trials. The database currently has 43 headache and 36 migraine studies listed. Topics include:

  • Improving migraine treatment in the ER
  • New preventives and abortives
  • Headache-specific studies of preventives and abortives currently used off-label
  • Studies specifically for adolescents and children
  • Nerve blocks
  • Menstrual migraine
  • Steroids for breaking rebound headaches
  • Controlling nausea
  • Marinol (a synthetic version of THC) as abortive
  • Contrast imaging for diagnosis
  • Nerve stimulation

And there are a lot 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, visit the site’s resources page.

The best feature is the map, where you can click on your state or nearby states for studies close to home.

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Drug Study Volunteers Misled?

Volunteers in drug studies often choose to participate based on misleading information, say medical ethicists in the latest issue of the British Medical Journal. They argue that drug companies conduct a certain type of skewed study merely for marketing purposes.

The type of study addressed is called open label extension studies. In these, participants in an earlier trial of a particular drug are invited to take the drug while it awaits regulatory approval so that the company can assess long-term safety of the drug.

According to a press release about the article,

“Many of the patients who volunteer to take part in [drug] studies have previously been involved in clinical trials of the product and are often recruited on the basis that they are helping scientific research.

“But researchers investigating OLES estimate that less than four per cent of these studies were published in scientific journals and found that many of the trials they looked at were of dubious scientific integrity.”

This is only one side of the story, of course, but it’s one I’ll consider if I decide to participate in a drug study. Although, I don’t know how much regulation of open label extension studies varies between the UK and other countries. Such studies are conducted in many other countries, including the US and Canada.

The full text of the journal article, not just the press release, is also available.