Use of Thalidomide in Patients With Arachnoiditis
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Purpose
This pilot study will evaluate whether thalidomide decreases pain in patients with arachnoiditis.
| Condition | Intervention | Phase |
|---|---|---|
|
Arachnoiditis |
Drug: thalidomide |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Prospective Study of the Use of Thalidomide in Patients With Arachnoiditis |
- 1. To evaluate the change in pain as measured by the McGill Pain Questionnaire, short form, (SF-MPQ) and consumption of adjuvant opioid medications in three patients with arachnoiditis who receive thalidomide.
- 2. To evaluate the change in physical functionality as measured by the Roland-Morris Low Back Pain and Disability Questionnaire in three patients with arachnoiditis who receive thalidomide.
- 1. To measure change in the patient's health status as measured by the SF36 in three patients with arachnoiditis who receive thalidomide.
| 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.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Radiographically confirmed Arachnoiditis
- Involvement of the lower limb(s)
Exclusion Criteria:
- Subjects with baseline peripheral neuropathy to include diabetic neuropathy and other metabolic or toxic neuropathies.
Contacts and Locations| 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 |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00284505 History of Changes |
| Other Study ID Numbers: | CG0678 |
| Study First Received: | January 30, 2006 |
| Last Updated: | December 4, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Washington University School of Medicine:
|
cytokine arachnoiditis neuropathic pain tumor necrosis factor |
Additional relevant MeSH terms:
|
Arachnoiditis Meningitis Central Nervous System Infections Central Nervous System Diseases Nervous System Diseases Thalidomide Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents |
ClinicalTrials.gov processed this record on June 17, 2013