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

Study Overview
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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.

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.

Official Title
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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

Conditions
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Central Neuropathic Pain in Multiple Sclerosis

Intervention / Treatment
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* Drug: Dronabinol
* Drug: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dronabinol<br> | Drug: Dronabinol<br>* oral solution, daily dose up to 15 mg, treatment up to 2.5 years<br>* Other names: (-)trans-delta9-tetrahydrocannabinol;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* oral solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change of baseline pain severity score on the 11-point Likert Numerical Rating Scale recorded in patient diary |  | max. 2.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Likert Numerical Rating Scale pain relief |  | max. 2.5 years | 
| Pain-related sleep interference |  | max. 2.5 years | 
| SF-36 (QoL-questionnaire) |  | max. 2.5 years | 
| Intake of rescue medication |  | 48 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dronabinol, (-)trans-delta9-tetrahydrocannabinol, central neuropathic pain, multiple sclerosis, analgesic, Central neuropathic pain related to multiple sclerosis