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Proposal 1280

Title of the Proposed Research

Placebo and nocebo effects in migraine Ver 2

Lead Researcher

Paul Enck

Affiliation

University Hospitals Tuebingen
Dept. of Internal Medicine
Tuebingen, Germany

Funding Source

Intramural funds

Potential Conflicts of Interest

None

Data Sharing Agreement Date

4 September 2015

Lay Summary

Placebo effects are immanent components of all medical interventions (therapies), whether in clinical trials or in daily routine. Placebo responses can be as high as 50% or more in clinical trials, especially with pain treatment (placebo analgesia), but the mechanisms steering this response are poorly understood. Among others, a previously effective treatment can predict higher response to a following intervention via learning, and expectations can drive the placebo response. The study we would like to gain access to is unique in the sense that it allows to test the hypothesis that a previously successful treatment (prevention of the next migraine attacks) by one or two applied drug will increase the response to a placebo application, and that a negative (non-effective) pre-treatment will reduce the placebo effect and eventually result in a worsening of sympotoms (called nocebo effect). A thorough analysis of individual predictors of positive (placebo) and negative (nocebo) responses to placebo interventions will allow better study designs and patient selections in future trials.

Study Data Provided

Study GSK-TRX109011: A Randomized, Double-blind, Double-dummy, Placebo-controlled, Crossover Study to Evaluate the Efficacy of TREXIMET® (Sumatriptan + Naproxen Sodium) vs. Butalbital-containing Combination Medications for the Acute Treatment of Migraine when administered during the Moderate-Severe Migraine Pain, 1 of 2
Study GSK-TRX109013: A Crossover, Randomized, Double-blind, Double-dummy, Placebo-controlled Study to Evaluate the Efficacy of TREXIMET®/Sumatriptan + Naproxen Sodium vs. Butalbital-containing Combination Medications for the Acute Treatment of Migraine when administered during Moderate-Severe Migraine Pain, 2 of 2

Statistical Analysis Plan

The statistical analysis plan will be added after the research is published.

Publication Citation

The publication citation will be added after the research is published.