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

Phase 3

Completed

• Conditions: Central Neuropathic Pain in Multiple Sclerosis
• Interventions: Drug: Placebo; Drug: Dronabinol

• Registration Number: NCT00959218
• Lead Sponsor: Bionorica Research GmbH

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 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 Timeline

• Study Start: 2007-06
• Study First Submitted: 2009-08-13
• Study First Submitted QC: 2009-08-13
• Study First Posted: 2009-08-14
• Primary Completion: 2010-03
• Study Completion: 2010-04
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-02
• Last Update Posted: 2012-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Dronabinol	Dronabinol	-

Primary Outcome Measures

Name	Time	Method
Mean change of baseline pain severity score on the 11-point Likert Numerical Rating Scale recorded in patient diary	max. 2.5 years

Secondary Outcome Measures

Name	Time	Method
SF-36 (QoL-questionnaire)	max. 2.5 years
Intake of rescue medication	48 weeks
Likert Numerical Rating Scale pain relief	max. 2.5 years
Pain-related sleep interference	max. 2.5 years

Trial Locations

Locations (1)

Maerkische Kliniken GmbH, Klinikum Luedenscheid, Akademisches Lehrkrankenhaus der Universitaet Bonn, Klinik fuer Neurologie; 🇩🇪 Luedenscheid, Germany