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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dronabinol | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dronabinol | Drug | oral solution, daily dose up to 15 mg, treatment up to 2.5 years |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sebastian Schimrigk, MD | Klinikum Luedenscheid | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maerkische Kliniken GmbH, Klinikum Luedenscheid, Akademisches Lehrkrankenhaus der Universitaet Bonn, Klinik fuer Neurologie | Lüdenscheid | 58515 | Germany |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D013759 | Dronabinol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| Placebo | Drug | oral solution |
|
| max. 2.5 years |
| Intake of rescue medication | 48 weeks |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |