Clinical Neuropharmacology of Pain in Spinal Cord Injury- Dextromethorphan/Lidocaine Combination Clinical Trial

Clinical Neuropharmacology of Pain in Spinal Cord Injury- Dextromethorphan/Lidocaine Combination (Factorial Design) Clinical Trial

Patrocinadores

Patrocinador principal: Brigham and Women's Hospital

Colaborador: National Institute of Neurological Disorders and Stroke (NINDS)

Fuente Brigham and Women's Hospital
Resumen breve

This randomized, placebo-controlled, double-blind 4x4 crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO) dextromethorphan and intravenous (IV) lidocaine in central neuropathic pain following spinal cord injury.

Descripción detallada

This trial has several objectives:

Primary Objective To determine which combination (dose-ratio) of dextromethorphan and lidocaine provides the best balance of pain reduction and toxicity.

Secondary Objectives include To evaluate the analgesic efficacy of both dextromethorphan and lidocaine in attenuating pain related to central nervous system sensitization, specifically spontaneous pain, mechanical allodynia, and hyperalgesia.

Estado general Completed
Fecha de inicio April 2003
Fecha de Terminación January 2008
Fecha de finalización primaria January 2008
Fase Phase 2
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Percent Change in Peak Pain Intensity 30 minutes post-infusion (Cmax)
Inscripción 26
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: Dextromethorphan

Descripción: Administered in 4 periods (placebo, low dose, medium dose, and high dose) for each subject, relative to each subject's MTD)

Tipo de intervención: Drug

Nombre de intervención: Lidocaine

Descripción: 0mg, 1mg, 2mg, and 4mg Lidocaine per kg of lean body mass (LBM), during each of the 4 dextromethorphan periods (placebo, low dose, medium dose, and high dose)

Tipo de intervención: Drug

Nombre de intervención: Placebo (Dextromethorphan)

Descripción: 0mg Dextromethorphan

Tipo de intervención: Drug

Nombre de intervención: Placebo (Lidocaine)

Descripción: 0mg/kg LBM Lidocaine

Elegibilidad

Criterios:

Inclusion Criteria:

1. Healthy male or female adults, age 18 to 70 with central neuropathic pain for a minimum of 3 months following SCI as confirmed by neurologic evaluation, with an average pain intensity score of at least moderate over at least 50% of the day for the 7 days prior to the screening visit and over the 7 days prior to starting study medication.

2. Subjects used no medication or a stabilized medication regimen for chronic and well-controlled medical conditions

3. Serum laboratory examination obtained at study entry:

4. Normal cognitive function.

5. Signed informed consent.

Exclusion Criteria:

1. Pregnancy or breast-feeding.

2. Renal or hepatic dysfunction.

3. Significant cardiac disease (e.g. MI within 1 year).

4. Signs or symptoms of central neurological disorder, excluding SCI.

5. Severe psychological disorder requiring treatment.

6. History of hypersensitivity or intolerance to dextromethorphan or lidocaine.

7. Participation in a study of an investigational drug or device within 30 days prior to screening for this study.

Género: All

Edad mínima: 18 Years

Edad máxima: 70 Years

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Christine N. Sang, MD, MPH Principal Investigator Translational Pain Research, Brigham and Women's Hospital (Disclosure: Patent)
Ubicación
Instalaciones: Translational Pain Research, Brigham and Women's Hospital
Ubicacion Paises

United States

Fecha de verificación

March 2018

Fiesta responsable

Tipo: Principal Investigator

Afiliación del investigador: Brigham and Women's Hospital

Nombre completo del investigador: Christine N. Sang, MD, MPH

Título del investigador: Director, Translational Pain Research

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 16
Grupo de brazo

Etiqueta: Placebo- 0mg/kg Lido

Tipo: Placebo Comparator

Descripción: Placebo in combination with 0mg/kg LBM lidocaine

Etiqueta: Placebo - 1mg/kg Lido

Tipo: Experimental

Descripción: Placebo in combination with 1mg/kg LBM lidocaine

Etiqueta: Placebo - 2mg/kg Lido

Tipo: Experimental

Descripción: Placebo in combination with 2mg/kg LBM lidocaine

Etiqueta: Placebo - 4mg/kg Lido

Tipo: Experimental

Descripción: Placebo in combination with 4mg/kg LBM lidocaine

Etiqueta: Low Dose Dex - 0mg/kg Lido

Tipo: Experimental

Descripción: Low dose dextromethorphan in combination with 0mg/kg LBM lidocaine

Etiqueta: Low Dose Dex - 1mg/kg Lido

Tipo: Experimental

Descripción: Low dose dextromethorphan in combination with 1mg/kg LBM lidocaine

Etiqueta: Low Dose Dex - 2mg/kg Lido

Tipo: Experimental

Descripción: Low dose dextromethorphan in combination with 2mg/kg LBM lidocaine

Etiqueta: Low Dose Dex - 4mg/kg Lido

Tipo: Experimental

Descripción: Low dose dextromethorphan in combination with 4mg/kg LBM lidocaine

Etiqueta: Medium Dose Dex - 0mg/kg Lido

Tipo: Experimental

Descripción: Medium dose dextromethorphan in combination with 0mg/kg LBM lidocaine

Etiqueta: Medium Dose Dex - 1mg/kg Lido

Tipo: Experimental

Descripción: Medium dose dextromethorphan in combination with 1mg/kg LBM lidocaine

Etiqueta: Medium Dose Dex - 2mg/kg Lido

Tipo: Experimental

Descripción: Medium dose dextromethorphan in combination with 2mg/kg LBM lidocaine

Etiqueta: Medium Dose Dex - 4mg/kg Lido

Tipo: Experimental

Descripción: Medium dose dextromethorphan in combination with 4mg/kg LBM lidocaine

Etiqueta: High Dose Dex - 0mg/kg Lido

Tipo: Experimental

Descripción: High dose dextromethorphan in combination with 0mg/kg LBM lidocaine

Etiqueta: High Dose Dex - 1mg/kg Lido

Tipo: Experimental

Descripción: High dose dextromethorphan in combination with 1mg/kg LBM lidocaine

Etiqueta: High Dose Dex - 2mg/kg Lido

Tipo: Experimental

Descripción: High dose dextromethorphan in combination with 2mg/kg LBM lidocaine

Etiqueta: High Dose Dex - 4mg/kg Lido

Tipo: Experimental

Descripción: High dose dextromethorphan in combination with 4mg/kg LBM lidocaine

Datos del paciente Undecided
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Factorial Assignment

Propósito primario: Treatment

Enmascaramiento: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Fuente: ClinicalTrials.gov