- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00242268
A Safety Study of Combination Treatment With Avonex and Zocor in Relapsing Remitting Multiple Sclerosis
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Multiple Sclerosis (MS) is an inflammatory demyelinating disease of the Central Nervous System (CNS). There are many forms of MS; althoughthe majority are Relapsing Remitting (RRMS) representing approximately 80% of the cases. The disease appears to be more inflammatory in RRMS as manisfested by an increase inGadolinium enhancement on MRI and an increase in inflammatory bioassay markers.
Zocor is in a class of drugs (statins) that are used to lower cholesterol. Statins also have an anti-inflammatory effect on the CNS. Zocor has been shown in a small clinical trial to reduce the number of new MRI-detected brain lesions over a six month treatment period in patients with RRMS. This study is to evaluate the safety of combining Avonex with Zocor for a a period of fourteen months in patients with RRMS and to evaluate the effect of treatment on new or enlarging lesions as measured by MRI.
Tipo de estudio
Inscripción
Fase
- Fase 3
Contactos y Ubicaciones
Estudio Contacto
- Nombre: William T. White, Pharm.D.
- Número de teléfono: 205-979-7555
- Correo electrónico: bwhite@sdr.us
Ubicaciones de estudio
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Alabama
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Birmingham, Alabama, Estados Unidos, 35209
- Reclutamiento
- Alabama Neurology Associates
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Investigador principal:
- Emily S. Riser, MD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Male or non-pregnant females age 18-55 who have clinically and laboratory definite relapsing-remitting MS using the MacDonald criteria.
Subjects must be taking some form of interferon therapy (Rebif, Avonex or Betaseron) for a duration of 12 months with documented breakthrough disease as defined:
- or = 1 documented clinical relapse in past 12 months while on interferon therapy. For eligibility, a pre-study relapse is defined as neurologic symptoms and signs documented by review of the history with the subject or in the medical record, of sufficient severity and duration to be determined by the investigator as consistent with an acute MS relapse.
The relapse does not need to have been treated to qualify. the timing of the relapse is defined based on the onset of symptoms.
OR
> or = 1 documented Gd-enhancing lesion on cranial or spinal MRI. The presence of a Gd-enhancing lesion must be documented either by a report in the medical record or review of the films by the investigator.
- The Kurtzke EDSS score must be between 0- 5.0.
- All subjects must give written consent prior to evaluation and testing.
Exclusion Criteria:
- Subjects with primary or secondary progressive MS.
- Female patients may not be pregnant, attempting pregnancy or breastfeeding.
- Female subjects must use an acceptable form of contraception during the study as defined by the investigators. The rhythm method is not to be used as the sole method of contraception.
- Subjects unwilling or unable to give informed consent.
- Subjects that are NAB+ (titers > or = 20).
Abnormal baseline blood test exceeding any of the limits defined below:
- ALT or AST > 2x upper limit of normal (ULN)
- CPK > 2x upper limit of normal (ULN)
- Total WBC < 3,000/mm3
- No chronic infections (including HIV and Hepatitis B/C) may be present.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
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1. To evaluate the safety of combining Avonex with Zocor for a period of fourteen months in patients with RRMS
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2. To evaluate the effect of treatment on MRI, specifically new or enlarging T2 lesions burden
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Medidas de resultado secundarias
Medida de resultado |
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1. To evaluate the effect on Relapse Rates
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2. To evaluate the effect on disease progression as measured with EDSS and MSFC
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Emily S. Riser, MD
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Enfermedades del Sistema Nervioso
- Enfermedades del sistema inmunológico
- Enfermedades Autoinmunes Desmielinizantes, SNC
- Enfermedades Autoinmunes del Sistema Nervioso
- Enfermedades desmielinizantes
- Enfermedades autoinmunes
- Esclerosis múltiple
- Esclerosis
- Esclerosis Múltiple Recurrente-Remitente
- Mecanismos moleculares de acción farmacológica
- Inhibidores de enzimas
- Antimetabolitos
- Agentes Anticolesterolémicos
- Agentes hipolipidémicos
- Agentes reguladores de lípidos
- Inhibidores de la hidroximetilglutaril-CoA reductasa
- Simvastatina
Otros números de identificación del estudio
- IST 03-09
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. .
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