Efficacy and Safety of the Pain Relieving Effect of Dronabinol in Central Neuropathic Pain Related to Multiple Sclerosis

Multi-centre, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of the Pain Relieving Effect of Dronabinol in Patients With Multiple Sclerosis Associated With Central Neuropathic Pain

The purpose of this study is to determine whether Dronabinol is effective and safe in relieving central neuropathic pain in multiple sclerosis patients.

Multiple sclerosis (MS) is in all probability an autoimmune disease causing severe neurological disability due to inflammation and degeneration in the central nervous system (CNS). MS affects over 1 million people worldwide. Central neuropathic pain is associated with approximately 30% of all patients with MS. MS-accompanying pain has a major impact on the patients' quality of life as usual conventional analgesics are little effective. The aim of this clinical study is to determine whether Dronabinol is effective and safe in relieving central neuropathic pain in multiple sclerosis patients.

Inclusion Criteria:

• Diagnosis of multiple sclerosis acc. to McDonald diagnostic criteria
• EDSS score between 3 and 8 (incl.)
• Patients who are in a stable phase of multiple sclerosis
• Patients with MS-related central neuropathic pain for at least 3 months

Exclusion Criteria:

• Severe concomitant diseases
• Certain concomitant therapies (in particular: pain influencing concomitant therapies)
• Dronabinol intake within the last 12 months prior to study entry or Marihuana use within one month prior to study entry