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Adamas Pharmaceuticals presenta datos clínicos positivos para ADS-5102, un tratamiento para la disquinesia inducida por levodopa, en el Congreso Mundial del Parkinson
Date:10/2/2013

ndo con las restantes actividades de solicitud de nuevo fármaco".

La prueba clínica EASED™ Fase 2/3 se creó para investigar la seguridad y la eficacia de tres niveles de dosis de ADS-5102 administradas una vez por la noche, a la hora de acostarse, para el tratamiento de la LID en la PD. En el estudio participaron 83 sujetos que fueron aleatorizados en una relación de 1:1:1:1 para los cuatro grupos de tratamiento: placebo, 260 mg de ADS-5102, 340 mg de ADS-5102 y 420 mg de ADS-5102. Tanto el nivel de dosis de 340 mg como el de 420 mg de ADS-5102 redujeron considerablemente la LID medida por el cambio en la puntuación total de la Escala Unificada para la Evaluación de la Disquinesia (UDysRS) en ocho semanas frente al placebo, alcanzando el punto final primario del estudio clínico. Es de notar que la reducción en la LID se vio a las dos semanas después de la primera dosis de medicamento en el estudio. En la octava semana, el período de respuesta a los medicamentos sin disquinesia molesta, medido por los diarios de los pacientes, fue de 11.0 horas, 11.5 horas y 12.1 horas para los niveles de dosis de 260 mg, 340 mg y 420 mg, respectivamente, en comparación con 8.0 horas para el placebo. Estos resultados fueron estadísticamente significativos, demostrando un incremento de unas 3 horas sobre el placebo en comparación con los valores de la línea de base.  ADS-5102 también mostró una mejora funcional estadísticamente significativa en la disquinesia evaluada según la parte IV de la MDS-Escala Unificada para la Evaluación de la Enfermedad de Parkinson (MDS-UPDRS), una medida del grado de impacto que la disquinesia tiene en la función diaria del paciente en actividades e interacciones sociales.

El tratamiento con ADS-5102 no dio como resultado un empeoramiento de la PD, según la medición de la puntuación combinada de MDS-UP
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SOURCE Adamas Pharmaceuticals, Inc.
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