Study of Pregabalin in the Prevention of Central Neuropathic Pain in Acute Spinal Cord Injury
Can Pregabalin Prevent the Development of Neuropathic Pain Following Spinal Cord Injury? A Double-Blind, Randomized, Placebo Controlled Trial.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Pregabalin is one of the few agents that have demonstrated effectiveness in the treatment of central NeP in SCI. Research is now proving that it is possible to prevent the development of pain in certain conditions. Pregabalin has been proven effective in this area with post surgical pain. Therefore, after traumatic SCI there may be a small window of time where we could prevent the development of NeP by administering an agent like Pregabalin.
Objective: To test the hypothesis that pregabalin is an effective treatment in preventing post-spinal cord injury neuropathic pain.
Design: double-blind, placebo controlled, randomized, trial Setting: Spinal cord injury program, neurosurgery and tertiary care rehabilitation center Subjects: 30 patients with acute traumatic spinal cord injury Method: Pregabalin will be offered to patients with acute traumatic spinal cord injury pain in a double blind crossover, placebo control design.
Main Outcome Measures: The primary outcome measures will be the development of Neuropathic Pain and intensity of pain Secondary outcome measures will be Ashworth's Scale for spasticity and ASIA motor and Sensory Scores.
Results: To be determined. Conclusion: To be determined.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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Nova Scotia
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Halifax, Nova Scotia, Canadá, B3h 4K4
- N.S Rehabilitation Center ,Capital Health
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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:
- Eligible participants will be 18 years of age or older
- Have suffered a traumatic spinal cord injury (complete or incomplete)
- Be free of Neuropathic pain
- Be in stable medical condition
Exclusion Criteria:
- Pregnant or lactating women: Because we do not know the risks of pregabalin in pregnancy, females of child bearing years must have a negative pregnancy test (performed on screening and subsequent follow up visits) and be using a reliable method of birth control including oral or injectible birth control hormones, barriers, intrauterine devices or tubal ligation, or abstinence throughout the duration of the study.
- Should a female become pregnant while participating in the study she will be un-blinded and, if on pregabalin, she will be weaned from the medication as quickly as is safe and withdrawn from the study. Appropriate follow-up for any pregnancy complications will be conducted.
- Persons with known hypersensitivity to pregabalin or its constituents
- Persons with Neuropathic pain at the time of enrollment
- Persons with a chronic pain diagnoses that may interfere with the evaluation of the presence of Neuropathic pain
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador de placebos: Pregabalin, (other name) Lyrica
Study subjects wil be randomized to either the Pregabalin or Placebo group.
There is a 5o ,50 chance of being in either group.
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study participants will start will be on 150mg of Pregabalin or placebo capsules by mouth , twice a day.They will be on drug approx.
49 weeks and followed for another 49 weeks after stopping the medication.
Otros nombres:
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Comparador de placebos: pregabalin, drug
study subjects that are randomized to the placebo group will receive matching placebo
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150 mg by mouth ,twice a day for 49 weeks
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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The primary outcome measures will be the development of Neuropathic Pain and intensity of pain .
Periodo de tiempo: the trial is 74 weeks in length
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the trial is 74 weeks in length
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Secondary outcome measures will be Ashworth's Scale for spasticity and ASIA motor and Sensory Scores.
Periodo de tiempo: trail is 74 weeks in length
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trail is 74 weeks in length
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Christine A. Short, Md FRCPC, Capital Health DHA Canada
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Dolor
- Manifestaciones neurológicas
- Heridas y Lesiones
- Enfermedades Neuromusculares
- Enfermedades del Sistema Nervioso Periférico
- Trauma, Sistema Nervioso
- Enfermedades de la médula espinal
- Neuralgia
- Lesiones de la médula espinal
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Depresores del sistema nervioso central
- Agentes del sistema nervioso periférico
- Analgésicos
- Agentes del sistema sensorial
- Agentes tranquilizantes
- Drogas psicotropicas
- Moduladores de transporte de membrana
- Agentes contra la ansiedad
- Anticonvulsivos
- Hormonas y agentes reguladores del calcio
- Bloqueadores de los canales de calcio
- Pregabalina
Otros números de identificación del estudio
- Pregabalin and SCI-Short
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