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

Central Neuropathic Pain in Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00959218
• Other study ID #: cnp-MS-0601 / MC-2006-01
• Status: Completed
• Phase: Phase 3
• First received: August 13, 2009
• Last updated: February 2, 2012
• Start date: June 2007
• Est. completion date: April 2010

Study information

• Verified date: February 2012
• Source: Bionorica Research GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesAustria: Federal Office for Safety in Health Care
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: April 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Central Neuropathic Pain in Multiple Sclerosis
• Multiple Sclerosis
• Neuralgia
• Sclerosis

Intervention

Drug:
• Dronabinol
oral solution, daily dose up to 15 mg, treatment up to 2.5 years
• Placebo
oral solution

Locations

Country	Name	City	State
Germany	Maerkische Kliniken GmbH, Klinikum Luedenscheid, Akademisches Lehrkrankenhaus der Universitaet Bonn, Klinik fuer Neurologie	Luedenscheid

Sponsors (1)

Lead Sponsor	Collaborator
Bionorica Research GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change of baseline pain severity score on the 11-point Likert Numerical Rating Scale recorded in patient diary		max. 2.5 years	No
Secondary	Likert Numerical Rating Scale pain relief		max. 2.5 years	No
Secondary	Pain-related sleep interference		max. 2.5 years	No
Secondary	SF-36 (QoL-questionnaire)		max. 2.5 years	No
Secondary	Intake of rescue medication		48 weeks	No