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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2010-04-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Central Neuropathic Pain in Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Dronabinol

Group Type EXPERIMENTAL

Dronabinol

Intervention Type DRUG

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

oral solution

Interventions

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Dronabinol

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

Intervention Type DRUG

Placebo

oral solution

Intervention Type DRUG

Other Intervention Names

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(-)trans-delta9-tetrahydrocannabinol

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No