Modeling and simulation for clinical trial of naratriptan based on proportional odds model

The aim of the study was to introduce the feasibility and utility of clinical trial simulation as applied to the clinical development of naratriptan. The probability of pain relief was estimated with the proportional odds model. The result was very close with the curve from the instruction. Clinical trial simulation resulted in a design with seven arms at 0, 1, 2.5, 5, 10, 15 and 20 mg. The curve of pain relief probability expressed pain relief trend directly with the change of dose, which gave a reference to the dose of naratriptan. Clinical trial simulation is a useful tool for the quantitative assessment of the influence of the controllable factors.