Investigation of mixed model repeated measures analyses and non-linear random coefficient models in the context of long-term efficacy data

Pharmaceutical Statistics
Bruno DelafontEmmanuel Pham

Abstract

The longitudinal data from 2 published clinical trials in adult subjects with upper limb spasticity (a randomized placebo-controlled study [NCT01313299] and its long-term open-label extension [NCT01313312]) were combined. Their study designs involved repeat intramuscular injections of abobotulinumtoxinA (Dysport®), and efficacy endpoints were collected accordingly. With the objective of characterizing the pattern of response across cycles, Mixed Model Repeated Measures analyses and Non-Linear Random Coefficient (NLRC) analyses were performed and their results compared. The Mixed Model Repeated Measures analyses, commonly used in the context of repeated measures with missing dependent data, did not involve any parametric shape for the curve of changes over time. Based on clinical expectations, the NLRC included a negative exponential function of the number of treatment cycles, with its asymptote and rate included as random coefficients in the model. Our analysis focused on 2 specific efficacy parameters reflecting complementary aspects of efficacy in the study population. A simulation study based on a similar study design was also performed to further assess the performance of each method under different patterns of response ove...Continue Reading

References

Oct 1, 1992·Statistics in Medicine·E F Vonesh
Sep 1, 2015·Lancet Neurology·Jean-Michel GraciesUNKNOWN International AbobotulinumtoxinA Adult Upper Limb Spasticity Study Group
Jun 8, 2017·Muscle & Nerve·Jean-Michel GraciesUNKNOWN International AbobotulinumtoxinA Adult Upper Limb Spasticity Study Group

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