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Sponsors and Collaborators: |
Washington University School of Medicine Celgene Corporation |
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Information provided by: | Washington University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00284505 |
This pilot study will evaluate whether thalidomide decreases pain in patients with arachnoiditis.
Condition | Intervention | Phase |
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Arachnoiditis |
Drug: thalidomide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Prospective Study of the Use of Thalidomide in Patients With Arachnoiditis |
Estimated Enrollment: | 3 |
Study Start Date: | July 2005 |
Study Completion Date: | July 2006 |
Arachnoiditis, a neuropathic disease caused by inflamation of the arachnoid membrane that surrounds and protects the spinal nerves,can result in a debilitating state that is characterized by numbing and tingling, stinging and burning in the lower back or legs, and possible muscle cramps, twitching and spasms. Current treatments are not always effective in treating the pain associated with arachnoiditis. Recent research has indicated that a group of chemicals called cytokines that are produced by various cells in the body may be responsible for generating the pain response. Medications that effect the release of cytokines or block the action of cytokines may reduce the pain response. Various anti-cytokine medications are now being used to treat painful disease states such as rheumotoid arthritis and Crohn's Disease. In this study the anti-cytokine medication, Thalidomide, is being evaluated for it's effect in treating pain associated with arachnoiditis.
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Missouri | |
Washington University Pain Management Center | |
St. Louis, Missouri, United States, 63141 |
Principal Investigator: | Anthony H Guarino, MD | Washington University in St. Louis |
Study ID Numbers: | CG0678 |
Study First Received: | January 30, 2006 |
Last Updated: | December 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00284505 History of Changes |
Health Authority: | United States: Food and Drug Administration |
cytokine arachnoiditis neuropathic pain tumor necrosis factor |
Anti-Infective Agents Anti-Bacterial Agents Necrosis Immunologic Factors Thalidomide Central Nervous System Infections |
Central Nervous System Diseases Pain Arachnoiditis Angiogenesis Inhibitors Immunosuppressive Agents Meningitis |
Anti-Infective Agents Thalidomide Immunologic Factors Antineoplastic Agents Growth Substances Nervous System Diseases Physiological Effects of Drugs Central Nervous System Diseases Arachnoiditis Angiogenesis Inhibitors |
Immunosuppressive Agents Pharmacologic Actions Meningitis Anti-Bacterial Agents Central Nervous System Infections Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Leprostatic Agents |