Calendario›JAZZ›Xyrem

Xyrem

Trial Comparing Effects of Xyrem Taken Orally and Modafinil With Placebo in Treating Daytime Sleepiness in Narcolepsy

Ensayo de Jazz Pharmaceuticals plc en Narcolepsia.

Más ensayos de: Narcolepsia.

Fase

Fase 3

Estado

Completado

Participantes

231

previstos

Centros

40

Fin del objetivo primario

jul 2004

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, triple ciego. Comenzó en abr 2003.

Qué mide

Latencia del sueño diurno medida por la Prueba de mantenimiento de la vigilia (MWT) (del inicio a la semana 8)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis study will be conducted as a randomized, double blind, double-dummy, placebo-controlled, parallel-group trial in patients diagnosed with narcolepsy. Volunteers for this trial will be required to make 5 visits over up to 14 weeks to a participating expert physician practitioner for various sleep and narcolepsy evaluations and diaries will also be collected. Participants will take assigned medications during the course of the trial. Subjects will have a 25% probability of receiving placebo for both drugs (modafinil and Xyrem). All subject volunteers must meet criteria for narcolepsy and have evidence of daytime sleepiness. Patients will not incur any personal medical expenses due to participation in this trial. The sponsor is covering all visit costs not covered by insurance and there are some funds for patient expenses such as travel.

Más ensayos de JAZZ

Todos los de JAZZ, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00066170), actualizada en dic 2011.