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Responsiveness of the Scripps Neurologic Rating Scale During a Multiple Sclerosis Clinical Trial

Published online by Cambridge University Press:  02 December 2014

James A. Koziol ,
Adriana Lucero ,
Jack C. Sipe ,
John S. Romine  and
Ernest Beutler
James A. Koziol
Affiliation:
Department of Molecular and Experimental Medicine, The Scripps Research Institute, La Jolla, California
Adriana Lucero
Affiliation:
Division of Neurology, Scripps Clinic, La Jolla, California
Jack C. Sipe
Affiliation:
Division of Neurology, Scripps Clinic, La Jolla, California
John S. Romine
Affiliation:
Division of Neurology, Scripps Clinic, La Jolla, California
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Abstract

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Objective:

The Scripps neurologic rating scale (SNRS) is a summary measure of individual components comprising a neurological examination, designed for use in multiple sclerosis (MS). Our objective is to evaluate the responsiveness of the SNRS, within the context of a 2-year, randomized, double-blind crossover study of the efficacy of cladribine for treatment of secondary progressive MS.

Methods:

Effect sizes were determined for the SNRS and its components, separately for each treatment group (initial placebo, and initial cladribine) over both years of the clinical trial, using a standard random effects model.

Results:

Individual components tended to show positive effect sizes (improvement) during periods of active therapy in both treatment groups, and negative effect sizes (deterioration) during periods of no active therapy. Summation indices derived from the individual components of the SNRS seemed somewhat more stable than the individual components. The two components mentation and mood, and bladder, bowel, or sexual dysfunction, were rather unresponsive in our clinical trial.

Conclusion:

Changes in the components of the SNRS over the course of our clinical trial were consistent between the two treatment groups. Most components were moderately responsive; and, the summary SNRS score appropriately summarized the moderate magnitudes of change evinced in the individual components.

Résumé

RÉSUMÉObjectif:

L'éelle neurologique de Scripps (ÉS), conç pour êe utilisédans la sclése en plaques (SEP), est une mesure sommaire de composantes individuelles incluant un examen neurologique. L'objectif de l'éde éit d'éluer la sensibilitée l'ÉS dans le contexte d'une éde randomisé en double insu avec chasséroiséde l'efficacitée la cladribine dans le traitement de la SEP secondaire progressive.

Méodes:

L'ampleur des effets a é dérminépour l'ÉS et ses composantes sérént pour chaque groupe de traitement (traitement initial: placebo ou cladribine) au cours des deux ans de l'éde clinique au moyen d'un modè standard àffets aléoires.

Réltats:

Les composantes individuelles tendaient àéntrer des effets positifs (améoration) pendant les péodes de traitement actif dans les deux groupes de traitement et des effets nétifs (dérioration) pendant les péodes sans traitement actif. Les indices de sommation dévédes composantes individuelles de l'ÉS semblaient plus stables que les composantes individuelles. Les deux composantes ét mental et humeur, et dysfonction vécale, intestinale ou sexuelle n'éient pas sensibles lors de cet essai thépeutique.

Conclusions:

Les changements dans les composantes de l'ÉS au cours de cet essai thépeutique éient concordants entre les deux groupes de traitement. La plupart des composantes éient modément sensibles et le score sommaire rémait de faç appropriél'ampleur modée des changements déntrépar les composantes individuelles.

Type
Original Articles
Information
Canadian Journal of Neurological Sciences , Volume 26 , Issue 4 , November 1999 , pp. 283 - 289
Copyright
Copyright © The Canadian Journal of Neurological 1999

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