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Abstract
Objective: Our objective was to identify patient, study, and site factors associated with assay sensitivity in placebo-controlled neuropathic pain trials.
Methods: We examined the associations between study characteristics and standardized effect size (SES) in a database of 200 publicly available randomized clinical trials of pharmacologic treatments for neuropathic pain.
Results: There was considerable heterogeneity in the SESs among the examined trials. Univariate meta-regression analyses indicated that larger SESs were significantly associated with trials that had 1) greater minimum baseline pain inclusion criteria, 2) greater mean subject age, 3) a larger percentage of Caucasian subjects, and 4) a smaller total number of subjects. In a multiple meta-regression analysis, the associations between SES and minimum baseline pain inclusion criterion and age remained significant.
Conclusions: Our analyses have examined potentially modifiable correlates of study SES and shown that a minimum pain inclusion criterion of 40 or above on a 0 to 100 scale is associated with a larger SES. These data provide a foundation for investigating strategies to improve assay sensitivity and thereby decrease the likelihood of falsely negative outcomes in clinical trials of efficacious treatments for neuropathic pain.
GLOSSARY
- ACTTION=
- Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks;
- CI=
- confidence interval;
- DPN=
- diabetic peripheral neuropathy;
- FDA=
- US Food and Drug Administration;
- NRS=
- numerical rating scale;
- PHN=
- postherpetic neuralgia;
- PRISMA=
- Preferred Reporting Items for Systematic Reviews and Meta-Analyses;
- RCT=
- randomized clinical trial;
- SES=
- standardized effect size;
- VAS=
- visual analog scale
Footnotes
Go to Neurology.org for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.
Supplemental data at www.neurology.org
- Received October 3, 2012.
- Accepted in final form March 13, 2013.
- © 2013 American Academy of Neurology
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