This five week (one week baseline and four weeks randomised treatment period), multi-centre, placebo controlled, parallel group, randomized withdrawal study will evaluate the maintenance of effect after long-term treatment with Sativex® in subjects with symptoms of spasticity due to MS who have been receiving long-term benefit from treatment with Sativex®. Subjects will be selected from the Supply of Unlicensed Sativex® (SUS) or named patient supply programmes and must have been receiving Sativex® for at least 12 weeks prior to study entry. Following informed consent and screening, eligible subjects will enter the study (Visit 1, Day 1) and commence a seven day open label baseline period, before returning for a randomisation visit (Visit 2, Day 7), at which point they are randomised to receive either Sativex® or placebo (randomised withdrawal period). Subjects will return to the centre for an end of study visit at week five (Visit 3, Day 35) or earlier if they withdraw from treatment. Spasticity and sleep disruption review and dosing diaries will be completed each day from the start of the baseline period until completion or withdrawal.
ANTECEDENTES: Open-label estudios no son ideales para proporcionar pruebas sólidas para el mantenimiento a largo plazo de la eficacia de los medicamentos, especialmente donde los medicamentos proporcionan alivio de los síntomas y si el uso a largo plazo de un placebo puede ser problemático y no ético.
OBJETIVO: Evaluar el mantenimiento de la eficacia de Sativex en sujetos que han ganado el alivio sintomático a largo plazo de la espasticidad en la esclerosis múltiple (EM), y para evaluar el impacto de la retirada de la medicina repentina.
MÉTODOS: Se utilizó un diseño de inscripción estudio aleatorizado retirada enriquecido. Los sujetos elegibles con beneficios preestablecidos de Sativex durante al menos 12 semanas entraron en esto, de grupos paralelos de 5 semanas controlado con placebo, el estudio aleatorizado de retirada. Se continuó dosis efectiva y tolerada anterior Cada sujetos.
RESULTADOS: Un total de 18 sujetos por grupo se inscribieron. Demografía mostraron una duración media de MS de 16,4 años, la espasticidad 12,7 años, la duración del uso de Sativex de 3,6 años (media 3,4 años) y una dosis media diaria de 8,25 aerosoles significa. El resultado primario de tiempo hasta el fracaso del tratamiento fue significativamente a favor de Sativex (p = 0,013). Las variables secundarias mostraron cambios significativos en el cuidador y del Asunto Global Impression of Change balanza a favor de Sativex.
CONCLUSIONES: Mantenimiento de la eficacia de Sativex en la mejoría sintomática a largo plazo de la espasticidad a un grupo de sujetos con EM se ha confirmado el uso de este diseño del estudio.
This five week (one week baseline and four weeks randomised treatment period), multi-centre, placebo controlled, parallel group, randomized withdrawal study will evaluate the maintenance of effect after long-term treatment with Sativex® in subjects with symptoms of spasticity due to MS who have been receiving long-term benefit from treatment with Sativex®. Subjects will be selected from the Supply of Unlicensed Sativex® (SUS) or named patient supply programmes and must have been receiving Sativex® for at least 12 weeks prior to study entry. Following informed consent and screening, eligible subjects will enter the study (Visit 1, Day 1) and commence a seven day open label baseline period, before returning for a randomisation visit (Visit 2, Day 7), at which point they are randomised to receive either Sativex® or placebo (randomised withdrawal period). Subjects will return to the centre for an end of study visit at week five (Visit 3, Day 35) or earlier if they withdraw from treatment. Spasticity and sleep disruption review and dosing diaries will be completed each day from the start of the baseline period until completion or withdrawal.
País»United Kingdom
Diseño del estudio»Ensayo controlado aleatorizado (ECA)
