Cross-over Study of Armodafinil Treatment of Daytime Sleepiness Associated With Treated Nocturia
22 de marzo de 2017 actualizado por: Duke University
A Double-Blind, Placebo-Controlled, Cross-over Study of Armodafinil Treatment of Daytime Sleepiness Associated With Treated Nocturia
The objective of the study is to evaluate armodafinil as a wakefulness-promoting therapy as a means of improving residual daytime sleepiness in patients with treated nocturia.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
81
Fase
- Fase 2
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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North Carolina
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Durham, North Carolina, Estados Unidos, 27710
- Duke University Medical Center
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 90 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Receiving standard-of-care therapy for nocturia based on assessment by study physician
- Evaluation by study physician indicates that the patient meets criteria for either overactive bladder diagnosis, or nocturnal polyuria diagnosis.
- Mean number of nocturia episodes at least 2 per night based on day sleep/bladder diary
- Epworth Sleepiness Scale Score of at least 10
- Clinical Global Impression of Sleepiness at least Moderate
- Age 18-90 years inclusive
Exclusion Criteria:
- Medications affecting urinary or sleep-wake function other than therapy for OAB o or NP within 5 half-lives of baseline assessment
- Sleep disorders other than nocturia based on history and screening assessment
- Unstable medical or psychiatry conditions
- Medical or psychiatric conditions affecting sleep/wake or urologic function
- Apnea-Hypopnea Index (AHI) ≥ 15 on screening polysomnogram
- Periodic Leg Movement Arousal Index (PLMAI) ≥ 15 on screening polysomnogram
- History of substance abuse or dependence in the last year
- Regular consumption of over 800 mg of caffeine use
- Shift-work in the 3 months prior to or during the study
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Armodafinil First, Then Placebo
During double-blind treatment subjects took armodafinil for 4 weeks before crossing over to placebo for 4 weeks. Pill is taken once daily, before 8 am. Armodafinil/placebo was initiated at a dose of 50 mg (1 tablet) and titrated to 150 mg after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 250 mg or reduced back to 50 mg based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects. |
Armodafinil 50 - 250 mg pills Subjects took armodafinil once daily, before 8 am.
Armodafinil was initiated at a dose of 50 mg (1 tablet) and titrated to 150 mg after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects.
After two weeks the medication could be increased to 250 mg or reduced back to 50 mg based on the investigator's and patient's perception of efficacy/side-effects.
No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
Subject given placebo tablets to match Armodafinil pills.
Subjects took placebo once daily, before 8 am.
Placebo was initiated as 1 tablet and titrated to 3 tablets after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects.
After two weeks the medication could be increased to 5 tablets or reduced back to 1 tablet based on the investigator's and patient's perception of efficacy/side-effects.
No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
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Comparador de placebos: Placebo First, Then Armodafinil
During double-blind treatment subjects took placebo for 4 weeks before crossing over to armodafinil for 4 weeks. Pill is taken once daily, before 8 am. Armodafinil/placebo was initiated at a dose of 50 mg (1 tablet) and titrated to 150 mg after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 250 mg or reduced back to 50 mg based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects. |
Armodafinil 50 - 250 mg pills Subjects took armodafinil once daily, before 8 am.
Armodafinil was initiated at a dose of 50 mg (1 tablet) and titrated to 150 mg after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects.
After two weeks the medication could be increased to 250 mg or reduced back to 50 mg based on the investigator's and patient's perception of efficacy/side-effects.
No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
Subject given placebo tablets to match Armodafinil pills.
Subjects took placebo once daily, before 8 am.
Placebo was initiated as 1 tablet and titrated to 3 tablets after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects.
After two weeks the medication could be increased to 5 tablets or reduced back to 1 tablet based on the investigator's and patient's perception of efficacy/side-effects.
No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change From Baseline in Epworth Sleepiness Scale [ESS]
Periodo de tiempo: Baseline, Week 4 of each phase
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Epworth sleepiness scale (ESS) is measure of subjective sleepiness.
Tendency to fall asleep in 8 situations.
Total varies from zero to 24.
A ESS of 10 or less is considered normal.
Change is calculated as value at baseline minus value at week 4.
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Baseline, Week 4 of each phase
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Clinical Global Impressions, Change in Severity of Excessive Daytime Sleepiness (EDS)
Periodo de tiempo: week 4, of each phase
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Scale consists of a 7 point likert rating scale where the anchors were 1= "normal"; 2= "borderline sleepiness"; 3= "mild sleepiness"; 4= "moderate sleepiness"; 5= "marked sleepiness"; 6= "severe sleepiness"; and 7= "among the most extremely sleepy individuals"
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week 4, of each phase
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Mean Number of Naps/Day
Periodo de tiempo: week 4 of each phase.
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measurements are for the preceding week
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week 4 of each phase.
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Mean Number of Minutes Napped Per Day Based on Sleep Diary
Periodo de tiempo: week 4 of each phase.
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measurements are for the preceding week
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week 4 of each phase.
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Mean Number of Nocturic Events (Episode of Urination Preceded and Followed by Sleep)
Periodo de tiempo: week 4 of each phase.
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Nocturic Events is defined as an episode of urination preceded and followed by sleep.
Measurements are for the preceding week
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week 4 of each phase.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Andrew Krystal, MD, Duke University
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de mayo de 2011
Finalización primaria (Actual)
1 de septiembre de 2015
Finalización del estudio (Actual)
1 de septiembre de 2015
Fechas de registro del estudio
Enviado por primera vez
28 de mayo de 2014
Primero enviado que cumplió con los criterios de control de calidad
28 de mayo de 2014
Publicado por primera vez (Estimar)
30 de mayo de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
24 de marzo de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
22 de marzo de 2017
Última verificación
1 de marzo de 2017
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Desordenes mentales
- Enfermedades del Sistema Nervioso
- Trastornos del Sueño Intrínsecos
- Disomnias
- Trastornos del sueño y la vigilia
- Síntomas del tracto urinario inferior
- Manifestaciones Urológicas
- Trastornos de somnolencia excesiva
- Somnolencia
- Nicturia
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Inductores de enzimas de citocromo P-450
- Inductores de citocromo P-450 CYP3A
- Estimulantes del Sistema Nervioso Central
- Agentes promotores de la vigilia
- Modafinilo
Otros números de identificación del estudio
- Pro00028116
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .