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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.
Sponsor:
Information provided by (Responsible Party):
Bionorica Research GmbH
ClinicalTrials.gov Identifier:
NCT00959218
First received: August 13, 2009
Last updated: February 2, 2012
Last verified: February 2012
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

Drug Information available for: Dronabinol
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Likert Numerical Rating Scale pain relief [ Time Frame: max. 2.5 years ] [ Designated as safety issue: No ]
  • Pain-related sleep interference [ Time Frame: max. 2.5 years ] [ Designated as safety issue: No ]
  • SF-36 (QoL-questionnaire) [ Time Frame: max. 2.5 years ] [ Designated as safety issue: No ]
  • Intake of rescue medication [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00959218

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

No publications provided

Responsible Party: Bionorica Research GmbH
ClinicalTrials.gov 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
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Austria: Federal Office for Safety in Health Care

Keywords provided by Bionorica Research GmbH:
Dronabinol
(-)trans-delta9-tetrahydrocannabinol
central neuropathic pain
 multiple sclerosis
analgesic
Central neuropathic pain related to multiple sclerosis

Additional relevant MeSH terms:
Multiple Sclerosis
Neuralgia
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pain
Neurologic Manifestations
Peripheral Nervous System Diseases
Neuromuscular Diseases
 Signs and Symptoms
Pathologic Processes
Tetrahydrocannabinol
Hallucinogens
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 21, 2013