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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:
ClinicalTrials.gov Identifier:
NCT00959218
First Posted: August 14, 2009
Last Update Posted: February 3, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bionorica Research GmbH
  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
Intervention Model: Parallel Assignment
Masking: Double (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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Bionorica Research GmbH
ClinicalTrials.gov Identifier: NCT00959218     History of Changes
Other Study ID Numbers: cnp-MS-0601 / MC-2006-01
First Submitted: August 13, 2009
First Posted: August 14, 2009
Last Update Posted: February 3, 2012
Last Verified: February 2012

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:
Sclerosis
Multiple Sclerosis
Neuralgia
Pathologic Processes
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
Dronabinol
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists