Status:
COMPLETED
Efficacy and Safety of the Pain Relieving Effect of Dronabinol in Central Neuropathic Pain Related to Multiple Sclerosis
Lead Sponsor:
Bionorica Research GmbH
Conditions:
Central Neuropathic Pain in Multiple Sclerosis
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether Dronabinol is effective and safe in relieving central neuropathic pain in multiple sclerosis patients.
Detailed 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 m...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00959218
Start Date
June 1 2007
End Date
April 1 2010
Last Update
February 3 2012
Active Locations (1)
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1
Maerkische Kliniken GmbH, Klinikum Luedenscheid, Akademisches Lehrkrankenhaus der Universitaet Bonn, Klinik fuer Neurologie
Lüdenscheid, Germany, 58515