Trial | NCT00959218  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    dronabinol ...

  • Study Participants

    240
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.
Study Started
Jun 30
2007
Primary Completion
Mar 31
2010
Study Completion
Apr 30
2010
Last Update
Feb 03
2012
Estimate

Drug Dronabinol

oral solution, daily dose up to 15 mg, treatment up to 2.5 years

  • Other names: (-)trans-delta9-tetrahydrocannabinol

Drug Placebo

oral solution

Dronabinol Experimental

Placebo Placebo Comparator

Criteria 

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
No Results Posted