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

This study has been completed.
Information provided by (Responsible Party):
Bionorica Research GmbH Identifier:
First received: August 13, 2009
Last updated: February 2, 2012
Last verified: February 2012
The purpose of this study is to determine whether Dronabinol is effective and safe in relieving central neuropathic pain in multiple sclerosis patients.

Condition Intervention Phase
Central Neuropathic Pain in Multiple Sclerosis
Drug: Dronabinol
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Bionorica Research GmbH:

Primary Outcome Measures:
  • Mean change of baseline pain severity score on the 11-point Likert Numerical Rating Scale recorded in patient diary [ Time Frame: max. 2.5 years ]

Secondary Outcome Measures:
  • Likert Numerical Rating Scale pain relief [ Time Frame: max. 2.5 years ]
  • Pain-related sleep interference [ Time Frame: max. 2.5 years ]
  • SF-36 (QoL-questionnaire) [ Time Frame: max. 2.5 years ]
  • Intake of rescue medication [ Time Frame: 48 weeks ]

Enrollment: 240
Study Start Date: June 2007
Study Completion Date: April 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dronabinol Drug: Dronabinol
oral solution, daily dose up to 15 mg, treatment up to 2.5 years
Other Name: (-)trans-delta9-tetrahydrocannabinol
Placebo Comparator: Placebo Drug: Placebo
oral solution

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.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00959218

Maerkische Kliniken GmbH, Klinikum Luedenscheid, Akademisches Lehrkrankenhaus der Universitaet Bonn, Klinik fuer Neurologie
Luedenscheid, Germany, 58515
Sponsors and Collaborators
Bionorica Research GmbH
Principal Investigator: Sebastian Schimrigk, MD Klinikum Luedenscheid
  More Information

Responsible Party: Bionorica Research GmbH Identifier: NCT00959218     History of Changes
Other Study ID Numbers: cnp-MS-0601 / MC-2006-01
Study First Received: August 13, 2009
Last Updated: February 2, 2012

Keywords provided by Bionorica Research GmbH:
central neuropathic pain
multiple sclerosis
Central neuropathic pain related to multiple sclerosis

Additional relevant MeSH terms:
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Neurologic Manifestations
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists processed this record on May 25, 2017