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

Bionorica

Status and phase

Completed

Phase 3

Conditions

Central Neuropathic Pain in Multiple Sclerosis

Treatments

Drug: Placebo

Drug: Dronabinol

Study type

Interventional

Funder types

Industry

Identifiers

NCT00959218

cnp-MS-0601 / MC-2006-01

Details and patient eligibility

About

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

Full description

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.

Enrollment

240 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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