Migraine Clinical Trials - What Should They Measure?
Obviously, clinical trials of Migraine medications have been conducted for many years, but have researchers been looking at the most appropriate endpoints (the overall outcomes that the trials is designed to evaluate)? A research poster exhibited at the 2012 annual scientific meeting of the American Headache Society did just that.
"This analysis considers the most appropriate endpoints for clinical decision-making in Migraine therapeutics."
In clinical trials, endpoints are the overall outcomes that the trials is designed to evaluate. Over the years, many different endpoints have been used to evaluate the efficacy (effectiveness) of medications in trials. "Decision-making about Migraine pharmacotherapy could be enhanced with better information about how therapies take patients' goals and preferences into account."
The researchers searched and analyzed medical literature.
- The traditional primary endpoint in Migraine trials, headache relief (reduction of moderate/severe pain to mild/no pain), and the next most frequently used endpoint, headache recurrence (return of pain after the initial relief), do NOT measure rapid relief or sustained relief.
- Headache relief and headache recurrence don't provide enough useful information when used alone.
- Since headache relief includes reduction to mild pain, it doesn't really provide information about pain-free response to the treatment and counts as treatment success.
- Headache recurrence can show sustained effectiveness, but it can also confused by an initial response and result in ineffective medications showing low recurrence rates.
"The measures of pain-free response two hours postdose (after taking medication) and sustained pain-free response can differentiate among treatments and be used to guide therapeutic choices in Migraine."
Summary and comments:
It was wonderful to see this poster and the consideration that went into it. Especially enlightening was the point that the headache relief endpoint allows relief that isn't pain-free to count as a treatment success. Is that really good enough? I think not. I sincerely hope that this research is taken seriously and causes clinical trial design and criteria to be rethought and redesigned. I applaud Dr's Silberstein, Marmura, Nahas, Newman, and Farr for this work. Thank you!
Silberstein, S. Marmura, M. Nahas, S.J.; Newman, L. Farr, S. "Efficacy Endpoints in Migraine Clinical Trials: The Importance of Assessing Freedom from Pain." Oral Presentation. Annual Scientific Meeting of the American Headache Society. Los Angeles. June, 2012.
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