gw-1000 and Spinal-Cord-Injuries

Spasticity in chronic spinal cord injury is a condition that can have negative repercussions on the patient's quality of life. Its treatment is complex and sometimes the outcome is insufficient. Cannabinoids have recently been used in multiple sclerosis to successfully treat spasticity that is refractory to other therapies.. To quantify the clinical response of a group of patients with spastic chronic spinal cord injury to the orally administered drug delta-9-tetrahydrocannabinol-cannabidiol (Sativex ®) as medication for use in special situations.. The research consists of a six-month observational study in patients with chronic spinal cord injuries with refractory spasticity. The variables collected were: modified Ashworth scale, Penn spasm frequency scale, Numeric Rating Scale, and Visual Analogue Scale for pain. Additionally, clinical variables and side effects of the treatment were also collected.. Fifteen patients took part in this study. A significant improvement was observed on three of the scales recorded: modified Ashworth scale (z = -2.97; p = 0.003), Penn spasm frequency scale (z = -2.76; p = 0.006) and Numeric Rating Scale (z = -3.21; p = 0.001). The use of the drug was withdrawn in two patients due to side effects.. Sativex can be considered an alternative in patients with spasticity associated with chronic spinal cord injury for whom other therapeutic measures have been insufficient. Further studies need to be conducted before the use of this drug can be recommended and so as to define a complete profile of its long-term side effects.. Delta-9-tetrahidrocannabinol-cannabidiol en el tratamiento de la espasticidad en la lesion medular cronica: una experiencia clinica.. Introduccion. La espasticidad en la lesion medular cronica es una condicion que puede repercutir negativamente en la calidad de vida del paciente. Su tratamiento es complejo y, en ocasiones, el resultado es insuficiente. Recientemente, en la esclerosis multiple los cannabinoides se han empleado con exito en el tratamiento de la espasticidad refractaria a otras terapias. Objetivo. Cuantificar la respuesta clinica de un grupo de pacientes con lesion medular cronica espastica al farmaco delta-9-tetrahidrocannabinol-cannabidiol (Sativex ®), de administracion oral, como medicamento de uso en situaciones especiales. Pacientes y metodos. Estudio observacional durante seis meses en lesionados medulares cronicos con espasticidad refractaria. Las variables recogidas fueron: escala modificada de Ashworth, escala de frecuencia de espasmos de Penn, Numeric Rating Scale y escala visual analogica del dolor. De forma adicional se recogieron variables clinicas y efectos secundarios del tratamiento. Resultados. Quince pacientes tomaron parte en el estudio. Se observo mejoria significativa en tres de las escalas registradas: escala de Ashworth modificada (z = -2,97; p = 0,003), escala de frecuencia de espasmos de Penn (z = -2,76; p = 0,006) y Numeric Rating Scale (z = -3,21; p = 0,001). Se suspendio el uso del farmaco en dos pacientes por efectos secundarios. Conclusiones. Sativex se muestra como una alternativa en pacientes con espasticidad asociada a lesion medular cronica, en las que otras medidas terapeuticas resultan insuficientes. Son necesarios mas estudios para recomendar el uso de este farmaco y definir un perfil completo de sus efectos adversos a largo plazo.

Topics: Adult; Aged; Cannabidiol; Chronic Disease; Dronabinol; Drug Combinations; Female; Humans; Male; Middle Aged; Muscle Spasticity; Spinal Cord Injuries; Treatment Outcome

GW Pharmaceuticals is developing GW-1000 (Sativex), a narrow ratio delta9-tetrahydrocannabinol:cannabidiol product for the potential treatment of multiple sclerosis, spinal cord injury, neurogenic pain and peripheral neuropathy. In March 2003, the company filed for approval for the treatment of MS with the UK Medicines Control Agency, and in May 2004, filed for new drug submission with Health Canada.

Topics: Administration, Oral; Analgesics; Animals; Biological Availability; Canada; Cannabidiol; Clinical Trials, Phase I as Topic; Clinical Trials, Phase II as Topic; Clinical Trials, Phase III as Topic; Dronabinol; Drug Approval; Drug Combinations; Drug Evaluation, Preclinical; Drug Industry; Humans; Hyperalgesia; Investigational New Drug Application; Mice; Molecular Structure; Multiple Sclerosis; Patents as Topic; Peripheral Nervous System Diseases; Phytotherapy; Plant Extracts; Plant Preparations; Randomized Controlled Trials as Topic; Spinal Cord Injuries; Structure-Activity Relationship