A Phase III Study of Civamide Nasal Solution (Zucapsaicin) for the Treatment of Episodic Cluster Headache

A Phase III, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Evaluation of Civamide (Zucapsaicin) Nasal Solution in the Treatment of Episodic Cluster Headache

Patrocinadores

Patrocinador principal: Winston Laboratories

Fuente Winston Laboratories
Resumen breve

This is a 49-day study to evaluate the effectiveness of Intranasal Civamide (Zucapsaicin) in the treatment of an episodic cluster headache period compared to placebo (medically inactive substance which does not contain any active ingredients).

Estado general Completed
Fecha de inicio January 2002
Fecha de Terminación July 2003
Fecha de finalización primaria July 2003
Fase Phase 3
Tipo de estudio Interventional
Inscripción 60
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: Civamide (Zucapsaicin)

Elegibilidad

Criterios:

- At least 2 year history of episodic cluster headache (meeting IHS criteria)

- At least 2 previous episodes

- Expected duration of cluster period is at least 6 weeks but not longer than 16 weeks

- At least 1 but not more than 8 headaches on each of the 3 days immediately prior to treatment

Género: All

Edad mínima: 18 Years

Edad máxima: N/A

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Scott B. Phillips, M.D. Study Director Winston Laboratories
Ubicación
Instalaciones:
Valley Neurological Headache & Research Center | Phoenix, Arizona, 85020, United States
Neurological Associates of Tucson | Tucson, Arizona, 85712, United States
Northern California Headache Clinic | Mountain View, California, 94040, United States
San Francisco Clinical Research Center | San Francisco, California, 94109, United States
California Medical Clinic for Headache | Santa Monica, California, 90404, United States
New England Center for Headache, PC | Stamford, Connecticut, 06902, United States
Neurology Clinical Research, Inc. | Plantation, Florida, 33324, United States
Neurology and Headache Specialists of Atlanta | Decatur, Georgia, 30033, United States
Diamond Headache Clinic | Chicago, Illinois, 60614, United States
Boston Clinical Research Center | Wellesley Hills, Massachusetts, 02481, United States
Michigan Headache Pain & Neurological Institute | Ann Arbor, Michigan, 48104, United States
Henry Ford Hospital Department of Neurology | Detroit, Michigan, 48202, United States
Department of Neurology Mayo Clinic | Rochester, Minnesota, 55905, United States
Mercy Health Research | Chesterfield, Missouri, 63017, United States
Headache Care Center/Clinvest | Springfield, Missouri, 65804, United States
Dartmouth Hitchcock Medical Center | Lebanon, New Hampshire, 03756, United States
New York Headache Center | New York, New York, 10021, United States
The Headache Wellness Center | Greensboro, North Carolina, 27401, United States
Cincinnati Headache Clinic | Cincinnati, Ohio, 45219, United States
Cleveland Clinic Foundation | Cleveland, Ohio, 44195, United States
University of Oklahoma | Oklahoma City, Oklahoma, 73104, United States
Neurological Associates of Tulsa, Inc. | Tulsa, Oklahoma, 74136, United States
Jefferson Headache Center | Philadelphia, Pennsylvania, 19107, United States
Nashville Neuroscience Center | Nashville, Tennessee, 37203, United States
Houston Headache Clinic | Houston, Texas, 77004, United States
The Neurology and Headache Treatment Center (Innovative Clinical Research) | Alexandria, Virginia, 22304, United States
Ubicacion Paises

United States

Fecha de verificación

June 2011

Fiesta responsable

Nombre Titulo: Scott B. Phillips, M.D., Study Director

Organización: Winston Laboratories, Inc.

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Treatment

Enmascaramiento: Double

Fuente: ClinicalTrials.gov