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

Bionorica Research GmbH240 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

240

Conditions

Central Neuropathic Pain in Multiple Sclerosis

Interventions

DronabinolDRUG

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

PlaceboDRUG

oral solution

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

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

Lüdenscheid, Germany

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

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