Clinical Research: Phase 1 - Phase 4

Six Insights To Treating Fibromyalgia

The journey to treating fibromyalgia has taken a sometimes circuitous path. After a burst of activity about a decade ago, the pursuit of new therapies took a years-long pause before reigniting in recent years. In the past five years, we’ve performed 16 fibromyalgia clinical trials (more than any other CRO), and here are some reflections on what that experience has taught us.

Diaries a must. Pain is the primary (though far from the only) efficacy measure in fibromyalgia drug trials, and there is no suitable substitute for patient diaries. Tracking pain response through office-only assessments has been considered relatively ineffective in our trials.

Good subjects, generally. Patients in fibromyalgia trials tend to be well-informed, web-savvy, motivated, and highly compliant. They want to get better and they seek support from a good network of patient groups. But there are exceptions, so read on …

Avoid patients with secondary gain. Sleep, the ability to function normally, and other quality-of-life assessments are vital to understanding patient response. We’ve found these measures to be more meaningful when we avoid patients who demonstrate secondary gain, as they may have built-in motivation not to improve. These patients also are less tolerant of side effects, more susceptible to placebo effect, and more likely to drop out.

One size doesn’t fit all. Patients come with a long list of comorbidities and must be approached from multiple angles. Those who have experienced multiple treatment failures seem less likely to succeed. Also, potential subjects may be taking many drugs that could disqualify them from trial participation.

Say no to opioids. We have not found opioids to be effective in treating fibromyalgia. If you’re looking at sites, ask what they’re prescribing. If they’re using opioids, ask how that’s been working — and if they make your short list, give them a closer look.

Pick the right team. When looking for a CRO, find a team that has experience doing these studies, has relationships with the top consultants, and is actively engaged with the leading fibromyalgia sites.

Fibromyalgia is a very complex indication with multiple mechanisms of action and treatment options. As such, it continues to be very much an unmet need. If you’d like to know more, check out our Town Hall Talk at APS.

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