Evaluation of the Efficacy of Cesamet™ for the Treatment of Pain in Patients With Multiple Sclerosis

A Multicenter Trial Evaluating the Efficacy of Cesamet™ for the Symptomatic Treatment of Pain in Patients With Multiple Sclerosis

This study was designed to evaluate the safety and efficacy of Cesamet™ in controlling pain in subjects experiencing pain due to Multiple Sclerosis.

The purpose of this study is to determine the safety and efficacy of Cesamet™ in the symptomatic treatment of pain due to Multiple Sclerosis.

This is a phase IV, multi-center, open label outpatient clinical trial evaluating Cesamet™ treatment for control of pain due MS. The study has two phases: a Pretreatment Phase and a Treatment Phase.

Inclusion Criteria:

• Patients diagnosed with MS
• Chronic daily pain present for at least 2 months.
• On stable analgesic regimen for one month
• Baseline pain score greater than 40mm on a visual analog scale.

Exclusion Criteria:

• Hypersensitivity to compounds in study drug or similar drugs
• Pregnant or lactating females
• Drug or alcohol abuse
• Unstable medical condition