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NCT Number: NCT00959218

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

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

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Key information

Conditions

Central Neuropathic Pain in Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Nervous System Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Maerkische Kliniken GmbH, Klinikum Luedenscheid, Akademisches Lehrkrankenhaus der Universitaet Bonn, Klinik fuer Neurologie

Lüdenscheid, 58515, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dronabinol

Drug

oral solution, daily dose up to 15 mg, treatment up to 2.5 years

Other names: (-)trans-delta9-tetrahydrocannabinol

Placebo

Drug

oral solution

Primary outcomes

  1. 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 outcomes

  1. Likert Numerical Rating Scale pain relief

    Time frame: max. 2.5 years

  2. Pain-related sleep interference

    Time frame: max. 2.5 years

  3. SF-36 (QoL-questionnaire)

    Time frame: max. 2.5 years

  4. Intake of rescue medication

    Time frame: 48 weeks

Sponsors and collaborators

Lead sponsor

Bionorica Research GmbH

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Aug 14, 2009
Registry last updated
Feb 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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